Osteoporosis risk to one in three woman in UAE
Alison McMeans
Last Updated: October 19. 2009 10:55PM UAE / October 19. 2009 6:55PM GMT ABU DHABI // One in three women in the Emirates is at risk of developing osteoporosis, a disease that causes fragile bones and can sometimes be fatal, according to a study to be released today.
The research, released in conjunction with World Osteoporosis Day, was conducted on 50,000 women in the UAE, Saudi Arabia and Kuwait since the beginning of last year. The women were approached in public venues, such as malls, and offered free bone screening. Half of those in Saudi Arabia were at risk, while the average across the region was two out of five.
When low bone density develops into osteoporosis, bones become brittle and more likely to break. The most serious are hip and spine fractures; overall they take longer to heal in osteoporosis patients, with 20 per cent of people dying and 50 per cent left with a permanent disability. Spinal fractures can also cause compression and lead to “dowager’s hump”, a mostly untreatable and painful ailment.
Yet the disease is “entirely preventable”, said Joanne Todd, a nutritionist and a researcher at Anlene, a line of dairy products fortified with vitamin D that backed the study.
Vitamin D, which is produced by exposure to sunlight and through diet and helps the body absorb calcium, is essential for strong bones. Low levels – common to the region – can lead to a host of health problems including osteoporosis.
Popular Posts
-
Dr. Humeira Badsha Medical center, Beach Park Plaza , Jumeira Beach Road Next to Neurospinal hospital. Phone +9714-3856009. Email info@dr...
-
Methotrexate is commonly prescribed and effectively used to treat rheumatoid arthritis and other rheumatic conditions . Methotrexate has t...
-
Yesterday I saw a lovely lady from the UK. She has been seeing her GP in the NHS system for many months with severe back pain radiating to ...
-
Articles - Peer Reviewed: 1. Badsha H, Gunes B, Grossman J, Brahn E. Troponin I assessment of cardiac involvement in patients with con...
-
Patients in Dubai still have a really hard time finding the right doctors for a variety of conditions. The right Specialists exist and usua...
-
PHILADELPHIA -- Milnacipran (Savella) improved pain and mental functioning in patients suffering from fibromyalgia, researchers said here. ...
-
I see many patients in Dubai whose fibromyalgia is not recognized or diagnosed for years. What Is Fibromyalgia? Fibromyalgia is a common con...
-
Being a Rheumatologist in the UAE is a unique experience. Most of my patients have had 3, 4 opinions for their disease, finding no solution...
-
UAE Residents Need to Get Out in the Sun More 24 May 2007 High Level of Osteopenia and Osteoporosis detected in recent screening programmes ...
Translate
Pages
Monday, November 16, 2009
Monday, October 26, 2009
Fibromyalgia Treatment - Posted by Humeira badsha Rheumatology Doctor in Dubai UAE
PHILADELPHIA -- Milnacipran (Savella) improved pain and mental functioning in patients suffering from fibromyalgia, researchers said here.
"Significant improvements in pain were seen by the second week of the dose escalation period and were sustained throughout the three-month treatment period," said Lesley M. Arnold, MD, a psychiatrist at the University of Cincinnati College of Medicine.
"An important benefit of milnacipran therapy may be the demonstrated ability to improve mental functioning in addition to pain," she told attendees at the American College of Rheumatology meeting.
Arnold said patients with fibromyalgia suffer a "constellation of symptoms that affect all parts of the body." The symptoms often interfere with sleep, and in turn cause difficulty concentrating.
Milnacipran is a selective, dual serotonin-norepinephrine reuptake inhibitor that was approved by the FDA earlier this year for the management of fibromyalgia.
Arnold reported that 27.7% of patients on milnacipran experienced at least a 50% decrease in 24-hour recall pain scores from baseline to endpoint compared with 18.1% of patients taking placebo (P<0.001).
In addition, after three months of therapy, a greater proportion of patients treated with milnacipran experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment.
"Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week one of treatment with a stable dose of milnacipran that persisted throughout the study," Arnold told MedPageToday.
Patients also showed significant improvements with the drug relative to placebo on the Mental Component Summary of the Short Form-36 (SF-36) assessment and the Fibromyalgia Impact Questionnaire (FIQ), which evaluates patients' overall ability to function.
Whereas placebo patients had a 0.5-point decrease in SF-36 mental scores from baseline, those on milnacipran had an increase of 1.54 points (P<0.001).
There was also a 5-point improvement in FIQ scores with milnacipran relative to placebo (P<0.001), Arnold reported.
She said the results are consistent with previous trials that have demonstrated the safety and efficacy of milnacipran at doses of 100 mg/day and 200 mg/day.
This phase III, double-blind, placebo-controlled trial of 1,025 fibromyalgia patients was designed to further evaluate the efficacy and tolerability of milnacipran 100 mg/day.
Arnold and her colleagues randomly assigned 516 patients to milnacipran 100 mg/day. Another 509 patients were assigned placebo. The patients underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.
"Fibromyalgia is a huge problem for a great many people," said Daniel Lewis, MD, of the Deakin University Integrative Health Research Unit in Melbourne, Australia. "This study shows that milnacipran appears to be helpful in reducing pain, but its impact in other areas is worth noting."
Lewis said the sleep disturbances and mental confusion are major problems for patients with fibromyalgia.
Arnold reported that the most common adverse event in both treatment groups was nausea, which, like other adverse events, tended to be mild to moderate in severity, with approximately 70% of the incidences in both groups resolved within three weeks after onset.
Discontinuations due to adverse events were 13.9% in the placebo group and 17.8% in the milnacipran group. About eight serious adverse events were experienced by milnacipran patients, six occurred among placebo patients.
"For most patients, milnacipran was well tolerated during the three-month treatment period," Arnold said.
"Significant improvements in pain were seen by the second week of the dose escalation period and were sustained throughout the three-month treatment period," said Lesley M. Arnold, MD, a psychiatrist at the University of Cincinnati College of Medicine.
"An important benefit of milnacipran therapy may be the demonstrated ability to improve mental functioning in addition to pain," she told attendees at the American College of Rheumatology meeting.
Arnold said patients with fibromyalgia suffer a "constellation of symptoms that affect all parts of the body." The symptoms often interfere with sleep, and in turn cause difficulty concentrating.
Milnacipran is a selective, dual serotonin-norepinephrine reuptake inhibitor that was approved by the FDA earlier this year for the management of fibromyalgia.
Arnold reported that 27.7% of patients on milnacipran experienced at least a 50% decrease in 24-hour recall pain scores from baseline to endpoint compared with 18.1% of patients taking placebo (P<0.001).
In addition, after three months of therapy, a greater proportion of patients treated with milnacipran experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment.
"Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week one of treatment with a stable dose of milnacipran that persisted throughout the study," Arnold told MedPageToday.
Patients also showed significant improvements with the drug relative to placebo on the Mental Component Summary of the Short Form-36 (SF-36) assessment and the Fibromyalgia Impact Questionnaire (FIQ), which evaluates patients' overall ability to function.
Whereas placebo patients had a 0.5-point decrease in SF-36 mental scores from baseline, those on milnacipran had an increase of 1.54 points (P<0.001).
There was also a 5-point improvement in FIQ scores with milnacipran relative to placebo (P<0.001), Arnold reported.
She said the results are consistent with previous trials that have demonstrated the safety and efficacy of milnacipran at doses of 100 mg/day and 200 mg/day.
This phase III, double-blind, placebo-controlled trial of 1,025 fibromyalgia patients was designed to further evaluate the efficacy and tolerability of milnacipran 100 mg/day.
Arnold and her colleagues randomly assigned 516 patients to milnacipran 100 mg/day. Another 509 patients were assigned placebo. The patients underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.
"Fibromyalgia is a huge problem for a great many people," said Daniel Lewis, MD, of the Deakin University Integrative Health Research Unit in Melbourne, Australia. "This study shows that milnacipran appears to be helpful in reducing pain, but its impact in other areas is worth noting."
Lewis said the sleep disturbances and mental confusion are major problems for patients with fibromyalgia.
Arnold reported that the most common adverse event in both treatment groups was nausea, which, like other adverse events, tended to be mild to moderate in severity, with approximately 70% of the incidences in both groups resolved within three weeks after onset.
Discontinuations due to adverse events were 13.9% in the placebo group and 17.8% in the milnacipran group. About eight serious adverse events were experienced by milnacipran patients, six occurred among placebo patients.
"For most patients, milnacipran was well tolerated during the three-month treatment period," Arnold said.
New treatment for Osteoarthritis. Reported By Dr. Humeira Badsha Rheumatologist Dubai, United Arab Emirates
PHILADELPHIA -- Patients who were treated with tanezumab, an investigational monoclonal antibody against nerve growth factor, had relief of osteoarthritis knee pain over the course of a year, researchers said here.
At a dosage of 50 mcg/kg, mean pain scores declined 26 points (SD 30) from a baseline mean of 67 after 16 weeks in the initial randomized, placebo-controlled study, according to Thomas Schnitzer, MD, PhD, of Northwestern University, who presented the findings at a poster session at the American College of Rheumatology's annual meeting.
After another 32 weeks of treatment at that dosage, mean scores declined an additional 9 points, settling at 35 (SD 27) at the end of the extension phase.
Pain scores in patients on higher and lower doses of the drug during the randomized portion appeared to converge toward the mid-30s when they were switched to the 50-mcg/kg dose during the extension.
"Repeated dosing with this compound gives sustained pain relief," Schnitzer said.
Tanezumab's target, nerve growth factor, plays an important role in the development of chronic pain states, such that the pain often takes on a life of its own, Schnitzer said.
Injured and inflamed tissues often show elevated levels of nerve growth factor, which in turns seems to mediate heightened perceptions of pain.
In addition to being studied for osteoarthritis knee pain, tanezumab has also been investigated as a treatment for pain associated with endometriosis, prostatitis, and bone metastases in cancer.
The current osteoarthritis study was an extension of a dose-ranging, placebo-controlled trial that found tanezumab significantly better than placebo in improving patients' walking pain and overall global assessment of response to treatment. That study tested five doses of tanezumab.
In the extension trial, patients on placebo, 10 mcg/kg of tanezumab or 25 mcg/kg of tanezumab said they achieved greater pain relief when switched to the 50 mcg/kg dose of tanezumab.
Schnitzer said patients who had been taking 100 mcg/kg and 200 mcg/kg said they experienced slightly decreased efficacy.
However, the mean pain scores by the end of the study were similar across all the treatment groups, he reported.
"Administration of repeat doses of tanezumab 50 mcg/kg in patients with moderate to severe osteoarthritis knee pain was safe and well tolerated for up to one year," Schnitzer said.
He said 281 patients entered the extension phase of the study. About 40% of the patients were men. The mean age of the group was 59, and 90% were white.
Most adverse events were rated as mild and transient, and none of the serious adverse events experienced in the study were considered drug-related. None of the participants died.
About 11% of the patients discontinued the study for lack of efficacy.
Asked whether a biologic drug could ever be cost-effective as a pain reliever in osteoarthritis -- having no impact on the underlying joint erosion -- Schnitzer said it was not out of the question.
He said it was conceivable that a year's treatment cost with the drug could be in the vicinity of $1,000, which would be competitive with more conventional brand-name drugs.
For example, the COX-2 inhibitor celecoxib (Celebrex) retails for about $1,500 per year at the most common dosage.
Joanne Jordan, MD, MPH, director of the arthritis center at the University of North Carolina in Chapel Hill, N.C., said that an alternative to opioid drugs would be welcome for patients whose pain is not controlled with nonsteroidal anti-inflammatory drugs.
"Patients don't like [opioids]," she said. "They're afraid of them, they worry about dependence."
Jordan agreed that pain in osteoarthritis cases "often doesn't match up with their structural abnormalities," suggesting a neurogenic component that may need to be targeted specifically in therapy.
Poster session discussant Timothy McAlindon, MD, of Tufts Medical Center in Boston, said there was increasing recognition that chronic pain from osteoarthritis may require treatments that go beyond the affected joints.
"We're beginning to recognize that chronic pain [from somatic conditions] has a neurological component," he said.
Treatments targeting pain regulators in the central nervous system are likely to attract more attention from rheumatologists in the future, McAlindon predicted
At a dosage of 50 mcg/kg, mean pain scores declined 26 points (SD 30) from a baseline mean of 67 after 16 weeks in the initial randomized, placebo-controlled study, according to Thomas Schnitzer, MD, PhD, of Northwestern University, who presented the findings at a poster session at the American College of Rheumatology's annual meeting.
After another 32 weeks of treatment at that dosage, mean scores declined an additional 9 points, settling at 35 (SD 27) at the end of the extension phase.
Pain scores in patients on higher and lower doses of the drug during the randomized portion appeared to converge toward the mid-30s when they were switched to the 50-mcg/kg dose during the extension.
"Repeated dosing with this compound gives sustained pain relief," Schnitzer said.
Tanezumab's target, nerve growth factor, plays an important role in the development of chronic pain states, such that the pain often takes on a life of its own, Schnitzer said.
Injured and inflamed tissues often show elevated levels of nerve growth factor, which in turns seems to mediate heightened perceptions of pain.
In addition to being studied for osteoarthritis knee pain, tanezumab has also been investigated as a treatment for pain associated with endometriosis, prostatitis, and bone metastases in cancer.
The current osteoarthritis study was an extension of a dose-ranging, placebo-controlled trial that found tanezumab significantly better than placebo in improving patients' walking pain and overall global assessment of response to treatment. That study tested five doses of tanezumab.
In the extension trial, patients on placebo, 10 mcg/kg of tanezumab or 25 mcg/kg of tanezumab said they achieved greater pain relief when switched to the 50 mcg/kg dose of tanezumab.
Schnitzer said patients who had been taking 100 mcg/kg and 200 mcg/kg said they experienced slightly decreased efficacy.
However, the mean pain scores by the end of the study were similar across all the treatment groups, he reported.
"Administration of repeat doses of tanezumab 50 mcg/kg in patients with moderate to severe osteoarthritis knee pain was safe and well tolerated for up to one year," Schnitzer said.
He said 281 patients entered the extension phase of the study. About 40% of the patients were men. The mean age of the group was 59, and 90% were white.
Most adverse events were rated as mild and transient, and none of the serious adverse events experienced in the study were considered drug-related. None of the participants died.
About 11% of the patients discontinued the study for lack of efficacy.
Asked whether a biologic drug could ever be cost-effective as a pain reliever in osteoarthritis -- having no impact on the underlying joint erosion -- Schnitzer said it was not out of the question.
He said it was conceivable that a year's treatment cost with the drug could be in the vicinity of $1,000, which would be competitive with more conventional brand-name drugs.
For example, the COX-2 inhibitor celecoxib (Celebrex) retails for about $1,500 per year at the most common dosage.
Joanne Jordan, MD, MPH, director of the arthritis center at the University of North Carolina in Chapel Hill, N.C., said that an alternative to opioid drugs would be welcome for patients whose pain is not controlled with nonsteroidal anti-inflammatory drugs.
"Patients don't like [opioids]," she said. "They're afraid of them, they worry about dependence."
Jordan agreed that pain in osteoarthritis cases "often doesn't match up with their structural abnormalities," suggesting a neurogenic component that may need to be targeted specifically in therapy.
Poster session discussant Timothy McAlindon, MD, of Tufts Medical Center in Boston, said there was increasing recognition that chronic pain from osteoarthritis may require treatments that go beyond the affected joints.
"We're beginning to recognize that chronic pain [from somatic conditions] has a neurological component," he said.
Treatments targeting pain regulators in the central nervous system are likely to attract more attention from rheumatologists in the future, McAlindon predicted
Vitamin D deficiency in kids
The AP (10/26, Tanner) reports that, according to a study published in Pediatrics, "at least one in five US children aged one to 11 don't get enough vitamin D and could be at risk for a variety of health problems, including weak bones." Harvard University researchers analyzed "data from a 2001-06 government health survey of nearly 3,000 children" who had undergone "blood tests measuring vitamin D levels." The investigators found that "about 20 percent of kids" under 12 had "blood levels that are too low." In addition, "applying a less strict, higher cutoff," the study authors found that "two-thirds of children that age, including 90 percent of black kids and 80 percent of Hispanics, are deficient in vitamin D."
Free Yoga Classes in Dubai UAE (And yoga specifically for arthritis)
Elevate your well-being with yoga!
Every Monday in the month of November At the Helipad Area, Festival Marina, Dubai Festival City with Dr. Vishwas Chhabra.
2nd November : 7.30am
9th November : 5.30pm
16th November : 7.30am
23rd November : 5.30pm
30th November : 7.30am
Duration of each class : 30mins to 45 mins.
All participants must remember to bring their own mats and drinking water.
Classes are free but we accept donations that go towards funding medical care for arthritis sufferers in the UAE. Donations are encouraged but not an obligation.
About Emirates Arthritis Foundation.
Emirates Arthritis Foundation is a non-profit organization that strives to breathe life into leading ideas of health, hope and happiness and to raise awareness about the rigours of arthritis. We launch a number of initiatives across the country to encourage education and understanding of arthritis; what it is, who it affects and how it affects them.
To learn more about the Emirates Arthritis Foundation and how you can help, please visit our website www.arthritis.ae.
Every Monday in the month of November At the Helipad Area, Festival Marina, Dubai Festival City with Dr. Vishwas Chhabra.
2nd November : 7.30am
9th November : 5.30pm
16th November : 7.30am
23rd November : 5.30pm
30th November : 7.30am
Duration of each class : 30mins to 45 mins.
All participants must remember to bring their own mats and drinking water.
Classes are free but we accept donations that go towards funding medical care for arthritis sufferers in the UAE. Donations are encouraged but not an obligation.
About Emirates Arthritis Foundation.
Emirates Arthritis Foundation is a non-profit organization that strives to breathe life into leading ideas of health, hope and happiness and to raise awareness about the rigours of arthritis. We launch a number of initiatives across the country to encourage education and understanding of arthritis; what it is, who it affects and how it affects them.
To learn more about the Emirates Arthritis Foundation and how you can help, please visit our website www.arthritis.ae.
Gout Treatment. Posted by Dr. Badsha, Rheumatologist, Dubai, United Arab Emirates
PHILADELPHIA -- Going beyond the recommended dosing of allopurinol (Zyloprim) to treat patients with gout may help prevent recurrence safely, researchers contended here.
"While allopurinol is the mainstay of treatment, physicians have concerns about increasing the dose above recommended guidelines particularly in patients with impaired kidney function, "said Lisa Stamp, MD, PhD, of the University of Otago in Christchurch, New Zealand.
"This has led to poor control of gout which causes significant pain, impacts on quality of life, and can lead to permanent joint damage," she said at the annual meeting of the American College of Rheumatology.
Stamp argued instead for a "treat-to-target" approach for urate lowering therapy.
She said using sufficient allopurinol to keep serum urate to less than 6 mg/dL may be a better strategy than persisting with doses perceived to be safe but which are inadequate to achieve the goals of treatment.
She explained that recommendations for allopurinol use are tied partly to kidney function. But these conservative doses may fail to achieve adequate serum uric acid reduction, she said.
Stamp and colleagues recruited 90 people with gout who were on a stable dose of allopurinol for at least one month. The average age of the participants was 58.3; 87.8% were male. At the initial visit, 52 participants had serum uric acid levels greater than 6 mg/dL, the critical level above which gout is more likely to occur.
For 45 participants their dose of allopurinol was increased anywhere from 50 to 400 milligrams above the recommended range. Of these, three developed rashes and discontinued the drug or went back to a lower dose, and six failed to attend follow-up appointments or developed intervening medical problems unrelated to gout.
Of the 36 patients who completed the 12-month study, 86% saw a drop in serum urate levels to 6 mg/dL or less.
"There was no increase in toxicity with higher doses of allopurinol in this cohort, including those with renal impairment," Stamp said. Three patients on high-dose allopurinol had rashes.
Baseline doses of allopurinol were about 35% higher in patients co-treated with furosemide (248 mg/day versus 180 mg/day in patients not given furosemide), Stamp reported.
But similar proportions of patients achieved the 6-mg/dL urate target whether they were on furosemide of not (72% versus 89%, P=0.24).
Increasing the dose of allopurinol above the recommended levels could help reduce gout attacks, agreed Eric Matteson, MD, of the Mayo Clinic in Rochester, Minn.
"The key message in this study is that in those patients who can tolerate the 300 mg dose of allopurinol, the dose can be safely pushed higher," Matteson said. "We may be far too conservative in treating these patients to prevent gout."
He noted, though, that 10% to 20% of people who are prescribed allopurinol cannot tolerate the drug because of adverse side effects.
"While allopurinol is the mainstay of treatment, physicians have concerns about increasing the dose above recommended guidelines particularly in patients with impaired kidney function, "said Lisa Stamp, MD, PhD, of the University of Otago in Christchurch, New Zealand.
"This has led to poor control of gout which causes significant pain, impacts on quality of life, and can lead to permanent joint damage," she said at the annual meeting of the American College of Rheumatology.
Stamp argued instead for a "treat-to-target" approach for urate lowering therapy.
She said using sufficient allopurinol to keep serum urate to less than 6 mg/dL may be a better strategy than persisting with doses perceived to be safe but which are inadequate to achieve the goals of treatment.
She explained that recommendations for allopurinol use are tied partly to kidney function. But these conservative doses may fail to achieve adequate serum uric acid reduction, she said.
Stamp and colleagues recruited 90 people with gout who were on a stable dose of allopurinol for at least one month. The average age of the participants was 58.3; 87.8% were male. At the initial visit, 52 participants had serum uric acid levels greater than 6 mg/dL, the critical level above which gout is more likely to occur.
For 45 participants their dose of allopurinol was increased anywhere from 50 to 400 milligrams above the recommended range. Of these, three developed rashes and discontinued the drug or went back to a lower dose, and six failed to attend follow-up appointments or developed intervening medical problems unrelated to gout.
Of the 36 patients who completed the 12-month study, 86% saw a drop in serum urate levels to 6 mg/dL or less.
"There was no increase in toxicity with higher doses of allopurinol in this cohort, including those with renal impairment," Stamp said. Three patients on high-dose allopurinol had rashes.
Baseline doses of allopurinol were about 35% higher in patients co-treated with furosemide (248 mg/day versus 180 mg/day in patients not given furosemide), Stamp reported.
But similar proportions of patients achieved the 6-mg/dL urate target whether they were on furosemide of not (72% versus 89%, P=0.24).
Increasing the dose of allopurinol above the recommended levels could help reduce gout attacks, agreed Eric Matteson, MD, of the Mayo Clinic in Rochester, Minn.
"The key message in this study is that in those patients who can tolerate the 300 mg dose of allopurinol, the dose can be safely pushed higher," Matteson said. "We may be far too conservative in treating these patients to prevent gout."
He noted, though, that 10% to 20% of people who are prescribed allopurinol cannot tolerate the drug because of adverse side effects.
Thursday, October 8, 2009
New Medicine for osteoarthritis, by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE
NicOx SA has filed a New Drug Application (NDA) for the first in a new class of anti-inflammatory agents, the CINODs (cyclooxygenase-inhibiting nitric oxide donators). The new drug, naproxcinod, is intended for the relief of the signs and symptoms of osteoarthritis (OA).
NicOx also expected to seek European approval for Naproxcinod
The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.
Michele Garufi, Chairman and CEO of NicOx, declared, "The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx's planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx's future commercial operations in the US."
No untoward blood pressure effects seen with naproxcinod
The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.
Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, said, "To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."
NicOx also expected to seek European approval for Naproxcinod
The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.
Michele Garufi, Chairman and CEO of NicOx, declared, "The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx's planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx's future commercial operations in the US."
No untoward blood pressure effects seen with naproxcinod
The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.
Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, said, "To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."
30 % of Back pain patients recover within a year. Article posted by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE
A third of patients may completely recover from chronic lower back pain by 9 months, according to a BMJ study.
Researchers enrolled some 400 patients who presented to general practitioners, physiotherapists, or chiropractors soon after experiencing low back pain and who had persistent pain at 3 months. The patients were followed for 1 year. By 9 months, some 35% had fully recovered (i.e., they were pain-free, had no back-related disability, and had fully returned to work), and by 12 months, 41% had.
The following groups were at increased risk for delayed recovery: those with previous sick leave related to low back pain, high disability levels at enrollment, lower education levels, and a higher perceived risk for persistent pain.
Link(s):
BMJ article (Free) http://click.jwatch.org/cts/click?q=227%3B67291090%3BTwT0Ho0B0jeunokFTBFf4qznfZCd4J%2F1IKrXW7GcEu8%3D
Researchers enrolled some 400 patients who presented to general practitioners, physiotherapists, or chiropractors soon after experiencing low back pain and who had persistent pain at 3 months. The patients were followed for 1 year. By 9 months, some 35% had fully recovered (i.e., they were pain-free, had no back-related disability, and had fully returned to work), and by 12 months, 41% had.
The following groups were at increased risk for delayed recovery: those with previous sick leave related to low back pain, high disability levels at enrollment, lower education levels, and a higher perceived risk for persistent pain.
Link(s):
BMJ article (Free) http://click.jwatch.org/cts/click?q=227%3B67291090%3BTwT0Ho0B0jeunokFTBFf4qznfZCd4J%2F1IKrXW7GcEu8%3D
Tuesday, September 15, 2009
New Treatment for Osteoarthritis.
The osteoporosis drug teriparatide (Forteo) stopped and even reversed cartilage loss in a mouse model of osteoarthritis," according to University of Rochester researchers. During the study, they severed the "medial collateral ligament in the legs of mice, which quickly leads to degeneration of cartilage in the affected joints -- much as similar injuries in human knees eventually induce osteoarthritis." After some eight weeks, "cartilage area was reduced about 20 percent, compared with mice given a sham surgery." Then, the injured mice received either "teriparatide or placebo immediately, continuing treatment for 12 weeks." By trial end, "teriparatide was associated with 20 to 27 percent more joint cartilage than in placebo-treated mice." The team was even more intrigued by the "mice who did not start drug treatment until eight weeks after the injury." Those mice "had 31 to 35 percent more cartilage at study week 12 (four weeks after starting treatment) than placebo-treated mice."
Sunday, September 13, 2009
Fasting and your arthritis.
During the holy month of Ramadan, Muslims including those with arthritis will fast from sunrise to sunset. There has been some evidence of the benefits of fasting and detoxification diets helping arthritis. However, some general precautions should be adhered to. For patients with arthritis, it is always wise to check with your Rheumatologist as to whether you can continue to fast and take medications which may be immune suppressants, or irritant to the stomach. Also the timing of your medications may vary during Ramadan and hence check with your doctor. If you have gout avoid red meats and shellfish. With all forms of arthritis a healthy, balanced diet is helpful. It is important during Ramadan to make sure one does not get dehydrated so take at least 8 -10 glasses of water between iftar and suhoor. Dehydration can be especially bad for those with gout or high uric acid levels, those with multiple medicines for rheumatoid arthritis, or anyone with kidney problems due to lupus. Fruit juices can be consumed in moderation. In fact pineapples contain an enzyme bromelain, which is useful for arthritis. Cherry juice may be helpful for gout. Oily fish or omega or fish oil supplements, ginger, garlic, turmeric, soya bean, avocadoes are some foods which are helpful. Remember to get 1000 mg of calcium from dairy products (1 glass of low fat milk has 290 mg of calcium, 1 cup of yogurt has 250 mg) and enough vitamin D through sun exposure, or else take a calcium supplement with vitamin D. Exercise in moderation. If exercising during fasting it may be wise to reduce your usual exercise duration and intensity by 30%, and be sure to warm up and cool down. Fasting during Ramadan can have many health and spiritual benefits. The Emirates Arthritis Foundation and doctors at Dubai Bone and Joint Center wish you a happy and peaceful holy month.
Sunday, August 9, 2009
Study of arthritis in the Emirates
The Emirates Foundation, Abu Dhabi, has awarded the
Emirates Arthritis Foundation a grant of AED 250,000.00 towards research
The welcome funding received from The Emirates Foundation has been allocated to assist with the study of Rheumatoid Arthritis in patients of Arab ancestry. This important research will result in a nationwide database of Rheumatoid Arthritis patients and will help to ascertain the need for financial support, disability and workplace assistance. From this information, EAF will be able to provide relevant assistance to people who most need it.
Rheumatoid Arthritis is a painful disease causing inflammation in the joints. It occurs in patients of all ages, but most prominently in women after the age of 25.
Emirates Arthritis Foundation formed under the patronage of Her Royal Highness Princess Haya Bint Al Hussein
Emirates Arthritis Foundation a grant of AED 250,000.00 towards research
The welcome funding received from The Emirates Foundation has been allocated to assist with the study of Rheumatoid Arthritis in patients of Arab ancestry. This important research will result in a nationwide database of Rheumatoid Arthritis patients and will help to ascertain the need for financial support, disability and workplace assistance. From this information, EAF will be able to provide relevant assistance to people who most need it.
Rheumatoid Arthritis is a painful disease causing inflammation in the joints. It occurs in patients of all ages, but most prominently in women after the age of 25.
Emirates Arthritis Foundation formed under the patronage of Her Royal Highness Princess Haya Bint Al Hussein
Early Treatment for Rheumatoid Arthritis. Posted Aug 10, Dubai, United Arab Emirates
Investigators say TNF blockers may benefit certain patients with early RA.
HealthDay (8/6, Preidt) reported, "Patients with early rheumatoid arthritis (RA) who respond poorly to standard treatment with methotrexate may benefit from additional treatment with tumor necrosis factor (TNF) blockers," according to a Swedish study published in The Lancet. "Previous research has shown that 20 to 40 percent of patients have a good response to methotrexate therapy and don't need more intensive combination treatment." Aiming to find a way to help the remaining percentage, researchers looked to "487 patients with early RA (less than one year's duration) who were initially treated with methotrexate." Some three to four months after treatment started, "the 258 patients with an inadequate response to methotrexate were randomly assigned to receive either the TNF blocker infliximib (Remicade) or the conventional disease-modifying antirheumatic drugs [DMARDs], sulfasalazine and hydroxychloroquine."
According to WebMD (8/6, Hitti), "one year later, 39 percent of the patients taking methotrexate plus Remicade had only low levels of RA symptoms, compared to 25 percent of patients taking methotrexate plus sulfasalazine and hydroxychloroquine." Lead investigator R.F. van Vollenhoven, MD, was quick to point out that the "difference between the two groups didn't happen right away; the Remicade-plus-methotrexate group took the lead after six months of treatment." Nevertheless, "the researchers aren't recommending anti-TNF drugs for everyone with RA, because anti-TNF drugs are more expensive than conventional drugs and aren't always needed or appropriate."
MedPage Today (8/6, Gever) quoted the authors, "In patients with early rheumatoid arthritis in whom methotrexate treatment failed, addition of a tumor necrosis factor antagonist to methotrexate monotherapy is clinically superior to addition of conventional disease-modifying antirheumatic drugs." The authors of an accompanying editorial, however, "argued that the study should not be interpreted as showing that infliximab is superior to oral DMARDs as the proper partner with methotrexate." In fact, "they noted that a statistical advantage can be found for biologic agents, even though only 20 percent of patients with suboptimal response to methotrexate do better on them." In other words, "the most important information to be gathered from clinical trials in rheumatoid arthritis is not necessarily comparisons of agents, but rather the strategy of tight control, aiming for remission."
HealthDay (8/6, Preidt) reported, "Patients with early rheumatoid arthritis (RA) who respond poorly to standard treatment with methotrexate may benefit from additional treatment with tumor necrosis factor (TNF) blockers," according to a Swedish study published in The Lancet. "Previous research has shown that 20 to 40 percent of patients have a good response to methotrexate therapy and don't need more intensive combination treatment." Aiming to find a way to help the remaining percentage, researchers looked to "487 patients with early RA (less than one year's duration) who were initially treated with methotrexate." Some three to four months after treatment started, "the 258 patients with an inadequate response to methotrexate were randomly assigned to receive either the TNF blocker infliximib (Remicade) or the conventional disease-modifying antirheumatic drugs [DMARDs], sulfasalazine and hydroxychloroquine."
According to WebMD (8/6, Hitti), "one year later, 39 percent of the patients taking methotrexate plus Remicade had only low levels of RA symptoms, compared to 25 percent of patients taking methotrexate plus sulfasalazine and hydroxychloroquine." Lead investigator R.F. van Vollenhoven, MD, was quick to point out that the "difference between the two groups didn't happen right away; the Remicade-plus-methotrexate group took the lead after six months of treatment." Nevertheless, "the researchers aren't recommending anti-TNF drugs for everyone with RA, because anti-TNF drugs are more expensive than conventional drugs and aren't always needed or appropriate."
MedPage Today (8/6, Gever) quoted the authors, "In patients with early rheumatoid arthritis in whom methotrexate treatment failed, addition of a tumor necrosis factor antagonist to methotrexate monotherapy is clinically superior to addition of conventional disease-modifying antirheumatic drugs." The authors of an accompanying editorial, however, "argued that the study should not be interpreted as showing that infliximab is superior to oral DMARDs as the proper partner with methotrexate." In fact, "they noted that a statistical advantage can be found for biologic agents, even though only 20 percent of patients with suboptimal response to methotrexate do better on them." In other words, "the most important information to be gathered from clinical trials in rheumatoid arthritis is not necessarily comparisons of agents, but rather the strategy of tight control, aiming for remission."
Tuesday, August 4, 2009
New medicine for Osteoporosis in breast cancer patients.Dr. Humeira Badsha, Consultant Rheumatologist Dubai, United Arab Emirates
Amgen says denosumab met goals in late-stage study.
The AP (8/4) reports, "Biotechnology company Amgen Inc. said Monday its drug denosumab met the goals of a late-stage study in treating patients with cancer that has spread to their bones." For the trial, researchers "compared denosumab and" Novartis AG's "Zometa [zoledronic acid] in the treatment of bone metastases in 1,776 advanced cancer patients." Amgen reported that "the two drugs had similar effects in delaying the length of time until a patient's first bone injury and subsequent bone injuries."
The trial also showed that "the time to a subsequent event, the secondary endpoint, was also better than Zometa's, though not by a statistically significant amount," Dow Jones Newswires (8/4, Gryta) reports. Currently, "the US Food and Drug Administration is also reviewing denosumab as a treatment for osteoporosis and bone loss caused by hormone treatment in patients with breast and prostate cancer."
Reuters (8/4, Berkrot) reports that the trial is the second of three planned studies testing the drug in patients with cancer that has spread to their bones. According to Amgen, full details of the trial are expected to be presented at a future medical meeting.
The AP (8/4) reports, "Biotechnology company Amgen Inc. said Monday its drug denosumab met the goals of a late-stage study in treating patients with cancer that has spread to their bones." For the trial, researchers "compared denosumab and" Novartis AG's "Zometa [zoledronic acid] in the treatment of bone metastases in 1,776 advanced cancer patients." Amgen reported that "the two drugs had similar effects in delaying the length of time until a patient's first bone injury and subsequent bone injuries."
The trial also showed that "the time to a subsequent event, the secondary endpoint, was also better than Zometa's, though not by a statistically significant amount," Dow Jones Newswires (8/4, Gryta) reports. Currently, "the US Food and Drug Administration is also reviewing denosumab as a treatment for osteoporosis and bone loss caused by hormone treatment in patients with breast and prostate cancer."
Reuters (8/4, Berkrot) reports that the trial is the second of three planned studies testing the drug in patients with cancer that has spread to their bones. According to Amgen, full details of the trial are expected to be presented at a future medical meeting.
Thursday, July 30, 2009
Rheumatoid Arthritis treatment in Dubai UAE, Emirates
In a recent study published in the Annals of Rheumatic Diseases it was found that care of Rheumatoid Arthritis in the uAE has improved and is now comparable to other High GDP countries. The only disparity is low access and use of the newer Biological agents due to their expense and lack of coverage.
Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST–RA database
T Sokka,1 H Kautiainen,2 T Pincus,3 S Toloza,4 G da Rocha Castelar Pinheiro,5
J Lazovskis,6 M L Hetland,7 T Peets,8 K Immonen,9 J F Maillefert,10 A A Drosos,11
R Alten,12 C Pohl,12 B Rojkovich,13 B Bresnihan,14 P Minnock,15 M Cazzato,16
S Bombardieri,16 S Rexhepi,17 M Rexhepi,17 D Andersone,18 S Stropuviene,19
M Huisman,20 S Sierakowski,21 D Karateev,22 V Skakic,23 A Naranjo,24 E Baecklund,25
D Henrohn,25 F Gogus,26 H Badsha,27 A Mofti,28 P Taylor,29 C McClinton,29 Y Yazici3
For numbered affiliations see
end of article
Correspondence to:
Dr T Sokka, Arkisto/Tutkijat,
Jyva¨skyla¨ Central Hospital,
40620 Jyva¨skyla¨, Finland;
tuulikki.sokka@ksshp.fi
Accepted 19 May 2009
Published Online First
This paper is freely available
online under the BMJ Journals
unlocked scheme, see http://
ard.bmj.com/info/unlocked.dtl
ABSTRACT
Objective: To analyse associations between the clinical
status of patients with rheumatoid arthritis (RA) and the
gross domestic product (GDP) of their resident country.
Methods: The Quantitative Standard Monitoring of
Patients with Rheumatoid Arthritis (QUEST–RA) cohort
includes clinical and questionnaire data from 6004
patients who were seen in usual care at 70 rheumatology
clinics in 25 countries as of April 2008, including 18
European countries. Demographic variables, clinical
characteristics, RA disease activity measures, including
the disease activity score in 28 joints (DAS28), and
treatment-related variables were analysed according to
GDP per capita, including 14 ‘‘high GDP’’ countries with
GDP per capita greater than US$24 000 and 11 ‘‘low
GDP’’ countries with GDP per capita less than US$11 000.
Results: Disease activity DAS28 ranged between 3.1 and
6.0 among the 25 countries and was significantly
associated with GDP (r = 20.78, 95% CI 20.56 to
20.90, r2 = 61%). Disease activity levels differed
substantially between ‘‘high GDP’’ and ‘‘low GDP’’
countries at much greater levels than according to
whether patients were currently taking or not taking
methotrexate, prednisone and/or biological agents.
Conclusions: The clinical status of patients with RA was
correlated significantly with GDP among 25 mostly
European countries according to all disease measures,
associated only modestly with the current use of
antirheumatic medications. The burden of arthritis
appears substantially greater in ‘‘low GDP’’ than in ‘‘high
GDP’’ countries. These findings may alert healthcare
professionals and designers of health policy towards
improving the clinical status of patients with RA in all
countries.
Health disparities, including high mortality rates,
are associated with low socioeconomic status in
many specific diseases in many countries.1–6
Furthermore, differences in gross domestic product
(GDP) in different countries are associated significantly
with differences in mortality rates among
countries.7–9 Most reports of these observations are
based on surveys and national databases, with
relatively limited information from clinical settings
based on physical examination, laboratory tests,
medications and patient self-report information
concerning functional status, pain, psychosocial
distress, etc, to understand further the basis for
these disparities. Furthermore, little is known
concerning associations of GDP and clinical outcomes
of chronic disabling musculoskeletal conditions
such as rheumatoid arthritis (RA).
A multinational database Quantitative Standard
Monitoring of Patients with Rheumatoid Arthritis
(QUEST–RA)10 11 was established to assess 100
unselected consecutive patients with RA per clinic
and included 25 countries by April 2008.
Considerable variation was observed in clinical
status in different countries according to most
clinical measures, whether derived from the physician,
patient or laboratory, as well as the
composite RA disease activity score in 28 joints
(DAS28) index.12 In this report, we compare
demographic characteristics, RA disease activity
measures and treatment-related variables between
‘‘high GDP’’ and ‘‘low GDP’’ countries, and analyse
associations between DAS28 and GDP.
Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST–RA database
T Sokka,1 H Kautiainen,2 T Pincus,3 S Toloza,4 G da Rocha Castelar Pinheiro,5
J Lazovskis,6 M L Hetland,7 T Peets,8 K Immonen,9 J F Maillefert,10 A A Drosos,11
R Alten,12 C Pohl,12 B Rojkovich,13 B Bresnihan,14 P Minnock,15 M Cazzato,16
S Bombardieri,16 S Rexhepi,17 M Rexhepi,17 D Andersone,18 S Stropuviene,19
M Huisman,20 S Sierakowski,21 D Karateev,22 V Skakic,23 A Naranjo,24 E Baecklund,25
D Henrohn,25 F Gogus,26 H Badsha,27 A Mofti,28 P Taylor,29 C McClinton,29 Y Yazici3
For numbered affiliations see
end of article
Correspondence to:
Dr T Sokka, Arkisto/Tutkijat,
Jyva¨skyla¨ Central Hospital,
40620 Jyva¨skyla¨, Finland;
tuulikki.sokka@ksshp.fi
Accepted 19 May 2009
Published Online First
This paper is freely available
online under the BMJ Journals
unlocked scheme, see http://
ard.bmj.com/info/unlocked.dtl
ABSTRACT
Objective: To analyse associations between the clinical
status of patients with rheumatoid arthritis (RA) and the
gross domestic product (GDP) of their resident country.
Methods: The Quantitative Standard Monitoring of
Patients with Rheumatoid Arthritis (QUEST–RA) cohort
includes clinical and questionnaire data from 6004
patients who were seen in usual care at 70 rheumatology
clinics in 25 countries as of April 2008, including 18
European countries. Demographic variables, clinical
characteristics, RA disease activity measures, including
the disease activity score in 28 joints (DAS28), and
treatment-related variables were analysed according to
GDP per capita, including 14 ‘‘high GDP’’ countries with
GDP per capita greater than US$24 000 and 11 ‘‘low
GDP’’ countries with GDP per capita less than US$11 000.
Results: Disease activity DAS28 ranged between 3.1 and
6.0 among the 25 countries and was significantly
associated with GDP (r = 20.78, 95% CI 20.56 to
20.90, r2 = 61%). Disease activity levels differed
substantially between ‘‘high GDP’’ and ‘‘low GDP’’
countries at much greater levels than according to
whether patients were currently taking or not taking
methotrexate, prednisone and/or biological agents.
Conclusions: The clinical status of patients with RA was
correlated significantly with GDP among 25 mostly
European countries according to all disease measures,
associated only modestly with the current use of
antirheumatic medications. The burden of arthritis
appears substantially greater in ‘‘low GDP’’ than in ‘‘high
GDP’’ countries. These findings may alert healthcare
professionals and designers of health policy towards
improving the clinical status of patients with RA in all
countries.
Health disparities, including high mortality rates,
are associated with low socioeconomic status in
many specific diseases in many countries.1–6
Furthermore, differences in gross domestic product
(GDP) in different countries are associated significantly
with differences in mortality rates among
countries.7–9 Most reports of these observations are
based on surveys and national databases, with
relatively limited information from clinical settings
based on physical examination, laboratory tests,
medications and patient self-report information
concerning functional status, pain, psychosocial
distress, etc, to understand further the basis for
these disparities. Furthermore, little is known
concerning associations of GDP and clinical outcomes
of chronic disabling musculoskeletal conditions
such as rheumatoid arthritis (RA).
A multinational database Quantitative Standard
Monitoring of Patients with Rheumatoid Arthritis
(QUEST–RA)10 11 was established to assess 100
unselected consecutive patients with RA per clinic
and included 25 countries by April 2008.
Considerable variation was observed in clinical
status in different countries according to most
clinical measures, whether derived from the physician,
patient or laboratory, as well as the
composite RA disease activity score in 28 joints
(DAS28) index.12 In this report, we compare
demographic characteristics, RA disease activity
measures and treatment-related variables between
‘‘high GDP’’ and ‘‘low GDP’’ countries, and analyse
associations between DAS28 and GDP.
Saturday, July 18, 2009
New treatment for Rheumatoid Arthritis soon in Dubai, United Arab Emirates
Starting September 2009, we will beable to offer a new treatment for Rheumatoid Arthritis,Actemra.
Patients with rheumatoid arthritis treated with ACTEMRA™ (tocilizumab) experienced a rapid and significant reduction in the signs and symptoms of their disease, according to a study published in this week's issue of The Lancet.
Results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial
a major Phase III international study - demonstrated that rheumatoid arthritis (RA) patients not only achieved greater improvement of symptoms but also a higher quality-of-life with ACTEMRA, an innovative interleukin-6 (IL-6) receptor inhibitor, compared with methotrexate, a commonly used RA treatment.
"Results of this pivotal study convincingly demonstrate that tocilizumab can effectively and rapidly diminish the painful and debilitating effects of rheumatoid arthritis," said Josef Smolen, M.D., lead investigator of the OPTION trial and Professor of Medicine at the Department of Internal Medicine at the Medical University of Vienna, Austria. "These trial findings are significant because we know that many rheumatoid arthritis patients continue to experience symptoms of joint pain and stiffness, physical disability and fatigue despite treatment with existing therapies."
Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling and ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and it represents a novel mechanism of action to treat RA. Research has shown that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, reduces inflammation of the joints and relieves certain systemic effects of RA.
About the OPTION Study
In the OPTION trial, a three-arm, double-blind, controlled Phase III study, 623 patients were randomized to receive ACTEMRA intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries outside the United States.
At 24 weeks, 58.5% of ACTEMRA patients (8mg/kg) achieved a 20% reduction in RA symptoms (ACR20)1, compared with 26.5% of patients in placebo plus metrotrexate patients. In the study, 43.9% of patients treated with ACTEMRA (8 mg/kg) plus methotrexate achieved at least a 50% (ACR50) reduction in symptoms compared to 10.8% of patients receiving placebo and methotrexate; ACR70 was achieved in 22% of the treatment group versus 2% in the control group. A rapid decrease in disease activity (DAS28)2 was seen as early as two weeks in a greater proportion of patients treated with ACTEMRA plus methotrexate, with 27.5% achieving clinical remission (DAS28≤ 2.6) by 24 weeks.
Additionally, results showed that 80% of patients in the ACTEMRA (8mg/kg) plus methotrexate group responded with moderate to good improvements in RA symptoms, according to the EULAR response criteria3, compared with 35% for those treated with placebo and methotrexate at 24 weeks.
The OPTION trial also assessed physical function and quality-of-life at baseline and every four weeks thereafter. Patients receiving ACTEMRA achieved significantly greater improvement in areas of fatigue and mental function at 24 weeks, and achieved normal levels of hemoglobin and C-reactive protein (CRP), a marker of inflammation due to RA, compared with patients receiving placebo plus methotrexate.
About ACTEMRA
ACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of ACTEMRA. Three other studies are completed and have reported meeting their primary endpoints. A fifth trial, a two-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is currently underway and is expected to report preliminary first-year data in 2008. ACTEMRA is awaiting approval in the United States and Europe. In Japan, ACTEMRA was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2006, additional indications for rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis were also filed in Japan.
ACTEMRA is generally well tolerated. The overall safety profile of ACTEMRA is consistent across all global clinical studies. The most common, non-serious, adverse events reported are upper respiratory tract infection, nasopharyngitis, headache and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections and hypersensitivity reactions including a few cases of anaphylaxis, have been reported in some patients treated with ACTEMRA. Increases in liver transaminases (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.
Patients with rheumatoid arthritis treated with ACTEMRA™ (tocilizumab) experienced a rapid and significant reduction in the signs and symptoms of their disease, according to a study published in this week's issue of The Lancet.
Results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial
a major Phase III international study - demonstrated that rheumatoid arthritis (RA) patients not only achieved greater improvement of symptoms but also a higher quality-of-life with ACTEMRA, an innovative interleukin-6 (IL-6) receptor inhibitor, compared with methotrexate, a commonly used RA treatment.
"Results of this pivotal study convincingly demonstrate that tocilizumab can effectively and rapidly diminish the painful and debilitating effects of rheumatoid arthritis," said Josef Smolen, M.D., lead investigator of the OPTION trial and Professor of Medicine at the Department of Internal Medicine at the Medical University of Vienna, Austria. "These trial findings are significant because we know that many rheumatoid arthritis patients continue to experience symptoms of joint pain and stiffness, physical disability and fatigue despite treatment with existing therapies."
Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling and ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and it represents a novel mechanism of action to treat RA. Research has shown that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, reduces inflammation of the joints and relieves certain systemic effects of RA.
About the OPTION Study
In the OPTION trial, a three-arm, double-blind, controlled Phase III study, 623 patients were randomized to receive ACTEMRA intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries outside the United States.
At 24 weeks, 58.5% of ACTEMRA patients (8mg/kg) achieved a 20% reduction in RA symptoms (ACR20)1, compared with 26.5% of patients in placebo plus metrotrexate patients. In the study, 43.9% of patients treated with ACTEMRA (8 mg/kg) plus methotrexate achieved at least a 50% (ACR50) reduction in symptoms compared to 10.8% of patients receiving placebo and methotrexate; ACR70 was achieved in 22% of the treatment group versus 2% in the control group. A rapid decrease in disease activity (DAS28)2 was seen as early as two weeks in a greater proportion of patients treated with ACTEMRA plus methotrexate, with 27.5% achieving clinical remission (DAS28≤ 2.6) by 24 weeks.
Additionally, results showed that 80% of patients in the ACTEMRA (8mg/kg) plus methotrexate group responded with moderate to good improvements in RA symptoms, according to the EULAR response criteria3, compared with 35% for those treated with placebo and methotrexate at 24 weeks.
The OPTION trial also assessed physical function and quality-of-life at baseline and every four weeks thereafter. Patients receiving ACTEMRA achieved significantly greater improvement in areas of fatigue and mental function at 24 weeks, and achieved normal levels of hemoglobin and C-reactive protein (CRP), a marker of inflammation due to RA, compared with patients receiving placebo plus methotrexate.
About ACTEMRA
ACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of ACTEMRA. Three other studies are completed and have reported meeting their primary endpoints. A fifth trial, a two-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is currently underway and is expected to report preliminary first-year data in 2008. ACTEMRA is awaiting approval in the United States and Europe. In Japan, ACTEMRA was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2006, additional indications for rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis were also filed in Japan.
ACTEMRA is generally well tolerated. The overall safety profile of ACTEMRA is consistent across all global clinical studies. The most common, non-serious, adverse events reported are upper respiratory tract infection, nasopharyngitis, headache and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections and hypersensitivity reactions including a few cases of anaphylaxis, have been reported in some patients treated with ACTEMRA. Increases in liver transaminases (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.
Rheumatoid Arthritis in Arab Patients
Dr. Humeira Badsha presented her findings as part of findings from the QUEST RA database. Seen here at the EULAR conference in Copenhagen (June 2009)with collaborators. Data from Morocco and Egypt was presented and compared to that from other developed countries. patients from North Africa had higher disease activity and more disability.
Wednesday, July 15, 2009
Higher weight increased risk for arthritis
the Los Angeles Times (7/14) Booster Shots blog, Jeannine Stein observed that, according to a study published in the August issue of the journal Radiology, being overweight "can be bad for the cartilage in your knees." Researchers from Boston University examined "data from the Multicenter Osteoarthritis Study of 3,026 people 50 to 79 who were at risk for osteoarthritis or had early evidence of the disease," focusing on "347 knees in 336 patients with an average BMI of 29.5." At study start, "most knees did not show evidence of tibiofemoral osteoarthritis," but after 30 months, "20 percent showed slow cartilage loss, and almost six percent showed rapid cartilage loss." Notably, "the only demographic feature that predicted rapid cartilage loss was having a high BMI at the start of the study."
"In fact, for every one-unit increase in body mass index, the chances of rapid cartilage loss increased 11 percent," HealthDay (7/14, Reinberg) reported. Moreover, the "association between obesity and rapid cartilage loss remained even after taking into account age, gender, and ethnic background." Study author Frank W. Roemer, MD, concluded, "We know that weight loss is probably the most important factor to slow disease progression." He added, "Osteoarthritis is the most common musculoskeletal disorder with major health and socioeconomic impact in our aging society."
"In fact, for every one-unit increase in body mass index, the chances of rapid cartilage loss increased 11 percent," HealthDay (7/14, Reinberg) reported. Moreover, the "association between obesity and rapid cartilage loss remained even after taking into account age, gender, and ethnic background." Study author Frank W. Roemer, MD, concluded, "We know that weight loss is probably the most important factor to slow disease progression." He added, "Osteoarthritis is the most common musculoskeletal disorder with major health and socioeconomic impact in our aging society."
Wednesday, February 18, 2009
Muscle pains in Dubai United Arab Emirates
RESEARCH IN DUBAI BONE AND JOINT CENTER
A diagnosis of Fibromyalgia or non-specific muscle pains in Arab or Indo-Pakistani women living in Dubai could mean vitamin D deficiency. This was equally true of veiled and non-veiled, but conservatively dressed populations, suggesting that sun exposure may not be the only factor involved. Prompt treatment with high dose Vitamin D could lead to resolution of all symptoms. If left untreated this severe vitamin D deficiency could have serious implications for the future bone health of the community. Further study of these populations and fortification of foods with Vitamin D may be required in future.
A diagnosis of Fibromyalgia or non-specific muscle pains in Arab or Indo-Pakistani women living in Dubai could mean vitamin D deficiency. This was equally true of veiled and non-veiled, but conservatively dressed populations, suggesting that sun exposure may not be the only factor involved. Prompt treatment with high dose Vitamin D could lead to resolution of all symptoms. If left untreated this severe vitamin D deficiency could have serious implications for the future bone health of the community. Further study of these populations and fortification of foods with Vitamin D may be required in future.
Life with Arthritis in Dubai
My name is Nael Hammad. I have been a rheumatoid apatient for 4 years and my medications have been sponsored by the Foundation for 2 years. When I was 29 years old I started feeling an intermittent, severe pain in my hips and some other joints. I started facing a lot of challenges in my daily activities. I was newly married and my social responsibilities were increasing in parallel with my disease complications. I started struggling with walking and faced limitations in dressing, however the biggest disaster concerned my professional life. I was growing in my career as a Regional Technical Manager in an international company when my employer noticed I was not performing well and I was unable to complete my objectives. The company decided to give my responsibilities to someone else and terminated me.
A lot of questions came to my mind, like, “Why me?”, “What have I done in my life to face such challenges?”, “Why at this stage of my life?”
I didn’t give up, but I started looking for a proper diagnosis. I spent a lot of time, money and effort visiting many doctors and receiving a variety of reports from apologies stating that doctors are unable to deal with my case to replacing both my hips with artificial joints. I did not find a good level of humanitarian and empathetic experience with any of the doctors or clinics that I had visited locally or regionally until I came to know about Dubai Bone & Joint Centre through the Emirates Arthritis Foundation. I feel that they gave me a unique experience in medical care and rebuilt the medical care image in my mind.
The unique smile which never evaporates from any of the DBAJ and EAF staff at any moment gives the patient comfort on a first impression. They give me sufficient time to explain my disease history and symptoms. They have introduced me to seminars where I met patients with experience on modifying their lifestyle to facilitate their existing situation. Social relationships with the patient’s family have been initiated to give better understanding for the patient’s day-to-day requirements. They remind me when it is time for my next injections which are fully funded by the
Foundation. I am informed and invited to any activity or event related to my disease.
Two years have passed since my first visit to DBAJ. There has been a remarkable change in my situation where I am able to live a normal life, act as a normal person and am not only responsible for myself but also support my wife and child. I have a better view of life today and will continue to grow in my career as I start my MBA program.
Best regards,
Nael Hammad
A lot of questions came to my mind, like, “Why me?”, “What have I done in my life to face such challenges?”, “Why at this stage of my life?”
I didn’t give up, but I started looking for a proper diagnosis. I spent a lot of time, money and effort visiting many doctors and receiving a variety of reports from apologies stating that doctors are unable to deal with my case to replacing both my hips with artificial joints. I did not find a good level of humanitarian and empathetic experience with any of the doctors or clinics that I had visited locally or regionally until I came to know about Dubai Bone & Joint Centre through the Emirates Arthritis Foundation. I feel that they gave me a unique experience in medical care and rebuilt the medical care image in my mind.
The unique smile which never evaporates from any of the DBAJ and EAF staff at any moment gives the patient comfort on a first impression. They give me sufficient time to explain my disease history and symptoms. They have introduced me to seminars where I met patients with experience on modifying their lifestyle to facilitate their existing situation. Social relationships with the patient’s family have been initiated to give better understanding for the patient’s day-to-day requirements. They remind me when it is time for my next injections which are fully funded by the
Foundation. I am informed and invited to any activity or event related to my disease.
Two years have passed since my first visit to DBAJ. There has been a remarkable change in my situation where I am able to live a normal life, act as a normal person and am not only responsible for myself but also support my wife and child. I have a better view of life today and will continue to grow in my career as I start my MBA program.
Best regards,
Nael Hammad
Saturday, February 7, 2009
Friday, January 23, 2009
Sunday, January 11, 2009
Arthritis Awards Dubai
Khaleej Times Online >> News >> NATION Perils of Juvenile ArthritisAsma Ali Zain
7 January 2009 Print E-mail
DUBAI - When five-year-old Mustafa Atef started to moan of pain in his knees and legs, his mother, Abeer, dismissed his complaints, chiding him instead for wanting to skip school.
It was only when the complaining became frequent and Mustafa’s knee joints became swollen that his 40-year-old mother took notice.
“I did not take his complaints seriously, thinking he might have hurt himself while playing,” explains Abeer. But she and her husband, Atef Lasheen, became extremely worried, she recalls, when day-by-day Mustafa’s condition started worsening and his legs became swollen and stiff.
For six months, the Egyptian couple ran from pillar to post. “It was a nightmare. Doctors treated him for a heart condition but no one here seemed to know what was wrong with Mustafa while his condition seemed to worsen, especially during the morning time,” she explains. It was during a trip to Egypt three years ago that Mustafa was diagnosed with Juvenile Idiopathic Arthritis or Rheumatoid Arthritis, a relatively rare disease affecting 0.5-1 per cent of children worldwide.
“We did not believe this diagnosis one bit because I remembered my grandmother complaining of knee pains and my five-year-old could not possibly have it,” she says, sill in disbelief.
Over the six months time until he was diagnosed, Mustafa changed from a happy child to a dejected one. He was in constant pain; could no longer play with his friends as he used to earlier and, even worse, his legs couldn’t bear his weight anymore.
It was also a frustrating time for the couple and their elder daughter who have been living in Sharjah for the past 14 years. “Handling a boy of his age and trying to explain to him why he was different from others was really a trying time for us,” says the mother. He became increasingly grumpy, moody and withdrawn.
“My heart ached to see him turn from a lively boy to a grumpy, bedridden lad,” says Abeer. Wintertime was worse. Mustafa had to wear double layers of clothes but still could not lessen the pain and stiffness in his joints.
For nearly a year after his diagnosis, Mustafa, now eight and a Grade 3 student of Westminster School, could not attend school. “I missed my friends and most of all, I missed playing football. It is my favourite game,” says an extremely shy Mustafa. Asking his mother to translate his feelings, Mustafa says he felt enormous pain in his legs as well as other parts of his body.
On the school front, Abeer had to pass special instructions to his teachers while his friends helped gather class notes for him.
“While back in the UAE, we were at a loss. We went to several experts in Sharjah but no one was really qualified. We were then referred to Al Mafraq in Al Ain,” explains Abeer.
However, for a working couple, it was an exhausting journey every 10 days. “We were finally referred to the Dubai Bone and Joint Centre (DBAJ) in Jumeirah where Mustafa is currently being treated free of cost for the past two years. “We still have to pay up to Dh1,500 for two injections per week,” adds Abeer.
Says Dr Humeira Badshah, Rheumatologist at DBAJ, “It is a rare disease affecting up to one per cent of children in the world. The cause of the disease remains unknown but the immune system gets overactive and the white blood cells attack one’s own body.”
Referring to Mustafa’s case, Dr Badsha says it was likely he would outgrow the disease when he turned 18. “But in some cases the patients have to continue treatment lifelong,” she explains.
“When he came to us, he was limping and his knees were extremely swollen, but luckily, his parents had caught the disease in time,” she says.
“In another case at the centre, an 11-year-old has his hand frozen at 90 degrees angle only because there was a delay in the treatment,” she says.
In severe cases, children with this disease may never grow properly and may also need bone replacement surgeries.
On December 16, Mustafa, and four other people were given the “Heroes for Arthritis” Award by Princess Haya bint Hussein, wife of His Highness Shaikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minster of the UAE and Ruler of Dubai, and Patron of the Emirates Arthritis Foundation (EAF) for their courage, selflessness and support in raising awareness on a number of arthritis-related diseases.
Mustafa now has to exercise regularly to keep his joints oiled. He also plays football and basketball and takes part in swimming.
asmaalizain@khaleejtimes.com
7 January 2009 Print E-mail
DUBAI - When five-year-old Mustafa Atef started to moan of pain in his knees and legs, his mother, Abeer, dismissed his complaints, chiding him instead for wanting to skip school.
It was only when the complaining became frequent and Mustafa’s knee joints became swollen that his 40-year-old mother took notice.
“I did not take his complaints seriously, thinking he might have hurt himself while playing,” explains Abeer. But she and her husband, Atef Lasheen, became extremely worried, she recalls, when day-by-day Mustafa’s condition started worsening and his legs became swollen and stiff.
For six months, the Egyptian couple ran from pillar to post. “It was a nightmare. Doctors treated him for a heart condition but no one here seemed to know what was wrong with Mustafa while his condition seemed to worsen, especially during the morning time,” she explains. It was during a trip to Egypt three years ago that Mustafa was diagnosed with Juvenile Idiopathic Arthritis or Rheumatoid Arthritis, a relatively rare disease affecting 0.5-1 per cent of children worldwide.
“We did not believe this diagnosis one bit because I remembered my grandmother complaining of knee pains and my five-year-old could not possibly have it,” she says, sill in disbelief.
Over the six months time until he was diagnosed, Mustafa changed from a happy child to a dejected one. He was in constant pain; could no longer play with his friends as he used to earlier and, even worse, his legs couldn’t bear his weight anymore.
It was also a frustrating time for the couple and their elder daughter who have been living in Sharjah for the past 14 years. “Handling a boy of his age and trying to explain to him why he was different from others was really a trying time for us,” says the mother. He became increasingly grumpy, moody and withdrawn.
“My heart ached to see him turn from a lively boy to a grumpy, bedridden lad,” says Abeer. Wintertime was worse. Mustafa had to wear double layers of clothes but still could not lessen the pain and stiffness in his joints.
For nearly a year after his diagnosis, Mustafa, now eight and a Grade 3 student of Westminster School, could not attend school. “I missed my friends and most of all, I missed playing football. It is my favourite game,” says an extremely shy Mustafa. Asking his mother to translate his feelings, Mustafa says he felt enormous pain in his legs as well as other parts of his body.
On the school front, Abeer had to pass special instructions to his teachers while his friends helped gather class notes for him.
“While back in the UAE, we were at a loss. We went to several experts in Sharjah but no one was really qualified. We were then referred to Al Mafraq in Al Ain,” explains Abeer.
However, for a working couple, it was an exhausting journey every 10 days. “We were finally referred to the Dubai Bone and Joint Centre (DBAJ) in Jumeirah where Mustafa is currently being treated free of cost for the past two years. “We still have to pay up to Dh1,500 for two injections per week,” adds Abeer.
Says Dr Humeira Badshah, Rheumatologist at DBAJ, “It is a rare disease affecting up to one per cent of children in the world. The cause of the disease remains unknown but the immune system gets overactive and the white blood cells attack one’s own body.”
Referring to Mustafa’s case, Dr Badsha says it was likely he would outgrow the disease when he turned 18. “But in some cases the patients have to continue treatment lifelong,” she explains.
“When he came to us, he was limping and his knees were extremely swollen, but luckily, his parents had caught the disease in time,” she says.
“In another case at the centre, an 11-year-old has his hand frozen at 90 degrees angle only because there was a delay in the treatment,” she says.
In severe cases, children with this disease may never grow properly and may also need bone replacement surgeries.
On December 16, Mustafa, and four other people were given the “Heroes for Arthritis” Award by Princess Haya bint Hussein, wife of His Highness Shaikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minster of the UAE and Ruler of Dubai, and Patron of the Emirates Arthritis Foundation (EAF) for their courage, selflessness and support in raising awareness on a number of arthritis-related diseases.
Mustafa now has to exercise regularly to keep his joints oiled. He also plays football and basketball and takes part in swimming.
asmaalizain@khaleejtimes.com
Saturday, January 3, 2009
Subscribe to:
Posts (Atom)