Pfizer has reported that tofacitinib, an investigational oral JAK inhibitor being evaluated in moderate-to-severe rheumatoid arthritis, has met the primary endpoints of a Phase III study.
The drug showed statistically significant changes compared to a placebo for reducing the signs and symptoms of rheumatoid arthritis, improving physical function and in reaching DAS28-4(ESR) <2.6 at six months.
The safety profile of tofacitinib was consistent with previously seen results of clinical programme, and no new safety signals were identified.
The study evaluated the efficacy and safety of tofacitinib doses 5mg and 10mg given twice daily compared to a placebo, in patients with moderately to severely active rheumatoid arthritis.
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet. Approximately 1.3 million people suffer from the condition in the US