• Kim A Papp, James G Krueger, Steven R Feldman, Richard G Langley, Diamant Thaci, Hideshi Torii, Stephen Tyring, Robert Wolk, Annie Gardner, Charles Mebus, Huaming Tan, Yingchun Luo, Pankaj Gupta, Lotus Mallbris, and Svitlana Tatulych.
• Probity Medical Research and K. Papp Clinical Research Inc, Waterloo, Ontario, Canada.
• J. Am. Acad. Dermatol. 2016 May 1; 74 (5): 841-50.

BackgroundTofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis.ObjectivesWe sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis.MethodsData from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID.ResultsAt week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure.LimitationsThere was no dose comparison beyond week 52.ConclusionsOral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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