The oral Janus kinase inhibitor tofacitinib was effective at treating rheumatoid arthritis in patients who had never before taken or had an inadequate response to biological disease-modifying antirheumatic drugs, according to a combined analysis of results from four phase II and five phase III trials conducted by Dr. Christina Charles-Schoeman and her associates.
Each of the two main study groups, consisting of 2,812 patients naive to biological disease-modifying antirheumatic drugs (bDMARDs) and 705 bDMARD patients with an inadequate response (IR), was further split into three subgroups: a placebo group, a group receiving 5 mg tofacitinib twice daily, and a group receiving 10 mg tofacitinib twice daily. All subgroups receiving medication had a significantly improved clinical response over the placebo group, although tofacitinib had greater efficacy in the bDMARD-naive group.
The rate of adverse events was similar in all groups receiving tofacitinib, though the numerical amount of both adverse events and clinical responses was somewhat higher in the 10-mg twice-daily group. In addition, a subpopulation of patients who also were receiving glucocorticoids tended to have more serious adverse events and discontinuations as a result of serious infections and herpes zoster.
Although bDMARD-IR patients did not respond as well to tofacitinib, “bDMARD-IR patients had longer disease duration and slightly greater disease activity at baseline compared with bDMARD-naive patients, which could have influenced these results,” the investigators noted.
Find the full study in Annals of the Rheumatic Diseases (doi: 10.1136/annrheumdis-2014-207178).