Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo‐controlled phase 3 trial

Tofacitinibis an oral Janus kinase inhibitor. These post-hoc analyses assessed tofacitinibefficacy and safety in Japanese patients with psoriasis enrolled in a 52-week global phase 3 study. Patients received tofacitinib5 mg, tofacitinib10 mg or placebo twice daily (b.i.d.); placebo-treated patients advanced to tofacitinibat week 16. Primary efficacy end-points were the proportions of patients with 75% or more reduction from baseline Psoriasis Areaand Severity Index(PASI-75) and Physician's Global Assessment (PGA) of “clear” or “almost clear” (PGA response) at week 16. Other end-points included: Itch Severity Item (ISI), Dermatology Life Quality Index(DLQI) score and Nail PsoriasisSeverity Index (NAPSI). Adverse events (AEs) were recorded throughout the study. Overall, 58 Japanese patients were included in this analysis ( tofacitinib5 mg b.i.d., n = 22; 10 mg b.i.d., n = 24; placebo, n = 12); 29 completed the study. At week 16, significantly more patients receiving tofacitinib5 and 10 mg b.i.d. versus placebo achieved PASI-75 (50% and 75% vs 0%, P < 0.01) and PGA response (59% and 75% vs 0%, P < 0.001). Substantial improvements in ISI, DLQI and NAPSI score were observed with both tofacitinibdoses. Over 52 weeks, similar rates of AEs were reported across treatment groups; one serious AE occurred with tofacitinib10 mg b.i.d. Herpes zoster occurred in three patients receiving tofacitinib10 mg b.i.d. No deaths, serious infections, malignancies or gastrointestinal perforationswere reported. Results were generally consistent with global analysis, suggesting sustained efficacy and a manageable safety profile, with increased herpes zoster incidence, of tofacitinibin Japanese patients with psoriasis.