Tofacitinib Efficacy Investigated in Patients With Psoriatic Arthritis
(HealthDay News) — For patients with active psoriatic arthritis who have an inadequate response to tumor necrosis factor (TNF) inhibitors or to conventional synthetic disease-modifying antirheumatic drugs (DMARDs), tofacitinib is superior to placebo, according to two studies published online Oct. 18 in the New England Journal of Medicine.
Dafna Gladman, M.D., from the University of Toronto, and colleagues randomized 395 patients with active psoriatic arthritis who had an inadequate response to TNF inhibitors in a 2-to-2-to-1-to-1 ratio to receive 5 or 10 mg tofacitinib twice daily or placebo with a switch to 5 mg or 10 mg tofacitinib at three months. The researchers found that the percentage of patients who had at least 20 percent improvement according to the American College of Rheumatology criteria (ACR20) at three months was 50 and 47 percent, respectively, for the 5- and 10-mg doses of tofacitinib and 24 percent for the placebo group.
Philip Mease, M.D., from the University of Washington in Seattle, and colleagues conducted a 12-month trial in which 422 patients with active psoriatic arthritis who had an inadequate response to synthetic DMARDs were randomized in a 2-to-2-to-2-to-1-to-1 ratio to receive tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg once every two weeks, or placebo with a blinded switch to tofacitinib 5 mg or 10 mg at three months. The researchers found that the ACR20 response rates at three months were 50 and 61 percent in the 5- and 10-mg tofacitinib groups compared with 33 percent in the placebo groups; the rate was 52 percent in the adalimumab group.
"The efficacy of tofacitinib was superior to that of placebo at month three in patients with psoriatic arthritis. Adverse events were more frequent with tofacitinib than with placebo," Mease and colleagues write.
Both studies were funded by Pfizer.