In a 6-month phase 3 study, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis (RA) in patients who had had an inadequate response to disease-modifying drugs. Improvement in physical function also was seen.
Fleischmann and colleagues randomly assigned 611 patients to 5 mg of tofacitinib bid; 10 mg of tofacitinib bid; placebo for 3 months, followed by 5 mg of tofacitinib bid; or placebo for 3 months, followed by 10 mg of tofacitinib bid. End points included American College of Rheumatology (ACR) 20 response and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores.
At 3 months, the criteria for an ACR 20 response were met by 59.8% and 65.7% of patients in the 5-mg and 10-mg tofacitinib groups, respectively, compared with 26.7% in the combined placebo groups. Reductions from baseline in HAQ-DI scores were greater in the 5-mg and 10-mg tofacitinib groups. The percentage of patients with a 28-joint Disease Activity Score based on the erythrocyte sedimentation rate was not significantly higher with tofacitinib. Adverse events with tofacitinib included headache and upper respiratory tract infection.
The authors noted that tofacitinib safety must be evaluated in a larger number of patients who have received treatment for longer periods.