Researchers studied the effectiveness and safety of tofacitinib (brand name Xeljanz) in combination with non-biologic DMARDs. Tofacitinib is a JAK (Janus kinase) inhibitor. There were 792 patients with active rheumatoid arthritis involved in the study which was conducted in 114 centers in 19 countries. The study participants were randomly assigned oral tofacitinib (5 mg or 10 mg twice daily) or placebo. At 3 months, patients in the placebo group who did not respond were blindly switched to 5 or 10 mg. tofacitinib twice daily.
Results, published August 20, 2013 in the Annals of Internal Medicine, revealed that response at 6 months was 21% greater for patients taking 5 mg. tofacitinib and 26% greater for patients taking 10 mg. tofacitinib compared to patients who were on placebo for 3 months and then switched to tofacitinib. Optimistic results, yes -- but the study had limitations. Placebo groups were smaller than the tofacitinib groups. Placebo was given for a shorter duration. Patients primarily received methotrexate, not other non-biologic DMARDs. Plus, the assessment of drug combinations other than tofacitinib plus methotrexate was limited. For example, patients were allowed to continue taking corticosteroids during the study.
