Rheumatologist in Dubai, UAE

Dr Badsha new location : Dr. Humeira Badsha Medical center, Beach Park Plaza , Jumeira Beach Road Next to Neurospinal hospital.  Phone +9714-3856009.  Email info@drbadshamedical.com

website: www.drbadshamedical.com

New Oral medication for Rheumatoid Arthritis!!

An FDA advisory committee has voted 8-2 in favor of recommending approval of the oral JAK inhibitor tofacitinib for the treatment of rheumatoid arthritis.
The agency's Arthritis Advisory Committee voted Wednesday that the efficacy and safety data support the use of tofacitinib for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
The panel was unanimous in its assessment of the drug's overall efficacy. "The evidence was compelling and was at least as good as for other biologics," said panelist Maria E. Suarez-Almazor, MD, PhD, of MD Anderson Cancer Center in Houston.
The efficacy was demonstrated in five phase III studies in which the primary endpoint was met, showing American College of Rheumatology 20% response rates ranging from 17% to 33% for the 5 mg dose and from 23% to 39% for the 10 mg dose.
"Statistically significant increases were seen on ACR20, 50, and 70 response rates in all five studies," said Nikolay Nikolov, MD, an FDA clinical reviewer.
Less clear was the efficacy as demonstrated on radiographic outcomes, which were assessed in only one study.
Analysis of this structural outcome was hampered by the fact that very little radiographic progression was seen in the placebo group.
In addition, the change in modified total Sharp scores seen in the 10 mg group appeared to be driven by one or more statistical outliers, and the small effect size was influenced by missing data and imputation methods.
"Radiographic outcome studies are difficult to do with limitations on the duration of placebo controls," said panel member David Blumenthal, MD, of Case Western Reserve University in Cleveland.
"We don't need certainty about radiographic outcomes today. That can be followed during postmarketing," Blumenthal added.
There also was considerable discussion about safety concerns that were raised in the phase III trials.
One area of concern was serious infections, which were seen at a rate of three per 100 patient-years, and most commonly were pneumonia and skin and soft tissue infections.
There also were 12 cases of tuberculosis, mostly in countries where the incidence is high, and 19 cases of serious herpes zoster.
Richard Riese, MD, PhD, of Pfizer noted that the company intends to have an action plan for zoster, in which immunization will be encouraged and follow-up data collected.

Osteoporosis gaps in treatment

I spoke at the Musculoskeletal conference in Vienna Austria on May 5th at the Osteoporosis symposium along Prof Ferrari and Resch.  The topic explored missed opportunities in the diagnosis and treatment of osteoporosis and new guideline by the French Society 2012 to address these.