By Deborah Abrams Kaplan

Tofacitinib is showing promise for patients with active psoriatic arthritis, a new study shows.

The study’s lead author, Philip J. Mease of the University of Washington in Seattle, presented the results of this randomized, double-blind, multicenter trial on Nov. 15 at the American College of Rheumatology annual meeting in Washington, D.C.

The clinical trial of 422 randomized patients - 405 who completed three months and 373 who completed 12 months - showed significant improvements in ACR20 response rates and the Health Assessment Questionnaire Disability Index at three months.

Patients received either 5 mg tofacitinib twice a day (107 patients), 10 mg tofacitinib twice a day (104 patients), or a 40 mg adalimumab subcutaneous injection every two weeks (106 patients). After two months of receiving placebos, the remaining 105 patients began receiving 5 mg (52 patients) or 10 mg (53 patients) of tofacitinib twice a day in a blinded way at month three. Investigators followed patients for 12 months and all patients received a stable dose of one csDMARD.

They found much higher ACR20 response rate improvements and ÎHAQ-DI scores for those starting on tofacitinib at study initiation, versus the placebo group who switched over in the third month, even though they were maintained on it through 12 months.

The ACR20 response rate to tofacitinib was higher for both tofacitinib groups compared to the placebo groups, as early as the second week (22.4% for the 5 mg group, 31.7% for the 10 mg group, and 5.7% for the placebo group). The safety findings were comparable in all the groups, with the most common adverse incidents being upper respiratory tract infection, nasopharyngitis and headache.

The patients in the trial met these criteria: a PsA diagnosis for at least six months; fulfilled classification criteria for psoriatic arthritis (CASPAR), active arthritis (three or more painful and swollen joints); active plaque psoriasis; inadequate response to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD); and tumor necrosis factor inhibitor-naive.

No new safety risks were identified vs previous studies in RA or psoriasis patients, but the most common adverse events over 12 months were upper respiratory tract infection (7.5–10.6% of pts across groups), nasopharyngitis (7.5–11.5%) and headache (3.8–10.6%)

Dr. Mease and his co-authors have ties with AbbVie, Amgen, Astellas, Biogen Idec, Boeringer Ingelheim, BMS, Celgene, Crescendo, Corrona, Daiichi, Dermira, Eli-Lilly, Galapagos, Imaging Rheumatology, Janssen, Momenta, Mallinckrodt, Novartis, Pfizer Inc, Roche, Sanofi-Aventis, Sun, UCB and Zynerba.

. "Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or Adalimumab in Patients with Active Psoriatic Arthritis and an Inadequate Response to Conventional Synthetic DMARDs: A Randomized, PlaceboâControlled, Phase 3 Trial,"

 11:15 a.m., Nov. 15, 2016. ACR/ARHP 2016 Annual Meeting.

Author | By Deborah Abrams Kaplan

Articles

Tofacitinib Shows Promise for PsA