Tofacitinib For Treatment of Chronic Plaque Psoriasis and Psoriatic Arthritis

Abstract

Background: Tofacitinib is an oral Janus Kinase Inhibitor, that leads to decreased expression of signal transducers and transcription factors. Tofacitinib is evaluated in patients with poor response to conventional DMARDs.Methods: In this 6-month randomized, placebo-controlled, double-blind trial, we randomly assigned 60 patients, in a 1:1:1 ratio, to three regimens: 5 mg of tofacitinib administered orally twice daily (20 patients); 10 mg of tofacitinib twice daily (20 patients); placebo twice daily (20 patients). The primary end points were the percentage of patients who had at least 50% improvement according to the criteria of the American College of Rheumatology (ACR50 response), the change from baseline score on the Health Assessment Questionnaire–Disability Index (HAQ-DI; scores range from 0 to 3 with higher scores indicating greater disability) at the month 3 analysis and PASI75 scores for patients who had 75% improvement from baseline PASI score.Results: At 6 months, the rates of ACR50 response were 40% with the 5-mg dose of tofacitinib and 50% with the 10-mg dose, as compared with 30% with placebo (P<0.001 for both comparisons); the corresponding mean changes from baseline in HAQ-DI score were −0.34 and −0.44, as compared with −0.30 (P<0.001 for both comparisons) and PASI75 scores were 57% and 75%, as compared to 50% with placebo. Serious adverse events occurred in one of the patients who received the 5-mg dose of tofacitinib continuously and in three patients who received the 10-mg dose continuously.Conclusions: In this trial involving patients with active chronic plaque psoriasis and psoriatic arthritis who had had an inadequate response to conventional DMARDS, tofacitinib was more effective than placebo over 6 months in reducing disease activity. Adverse events were more frequent with tofacitinib than with placebo.