Drug Updates

Results of the phase 3 clinical trials for tofacitinib, an oral janus kinase inhibitor, were recently reported at EULAR.²⁰ At six months, an ACR20 response was achieved in 58% of patients who received tofacitinib 10 mg twice daily (BID) in those who had not previously responded to disease-modifying antirheumatic drugs (DMARDs). Placebo-treated patients had a 31% response. Background DMARDs included MTX, leflunomide, sulfasalazine, hydroxychloroquine, penicillamine, and gold (as single and combination therapies). Significant improvements were also seen in the 5 mg BID tofacitinib-dosed group. Adverse events were mostly mild, and no new safety signals were reported. Multinational 12-month clinical trial results (n=792) showed ACR50 and ACR70 responses in 36.6% and 16.2% of patients, respectively, in the tofacitinib 10-mg BID group, versus 12.7% and 3.2%, respectively, for placebo-treated patients. These results were considered significant symptom improvements. Significant improvements compared with placebo were also observed in the DAS physician index and the Health Assessment Questionnaire Disease Index. According to researchers, significant ACR 20, ACR50, and ACR70 responses were seen after two weeks of therapy.

Michele Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

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