Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two, randomised, placebo-controlled, Phase 3 trials (original) (raw)

Tofacitinib is an oral JAK inhibitor being investigated for psoriasis. To determine 16-week efficacy and safety of two oral tofacitinib doses vs placebo in patients with moderate to severe chronic plaque psoriasis. Patients in two similarly designed Phase 3 studies (OPT Pivotal 1, NCT01276639 [N=901]; OPT Pivotal 2, NCT01309737 [N=960]) were initially randomised 2:2:1 to tofacitinib 10 mg, 5 mg or placebo, twice daily. Co-primary efficacy endpoints (Week 16) included proportion of patients achieving Physician's Global Assessment (PGA) of "clear" or "almost clear" (PGA response) and proportion achieving ≥75% reduction in Psoriasis Area and Severity Index (PASI75). Across OPT Pivotal 1 and OPT Pivotal 2, 745 patients received tofacitinib 5 mg, 741 received tofacitinib 10 mg and 373 received placebo. At Week 16, a greater proportion of patients achieved PGA responses with tofacitinib 5 and 10 mg twice daily vs placebo (OPT Pivotal 1: 41.9% and 59.2% vs 9.0%; OPT...