Background: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical\nagents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small\nmolecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMethods: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of\ntofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque\npsoriasis. Primary endpoint: proportion of patients with Calculated Physician�s Global Assessment (PGA-C) clear or\nalmost clear and �2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of\npatients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75)\nresponse; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item\n(ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nResults: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients\nwith PGA-C clear or almost clear and �2 grade improvement from baseline at Week 8 was 18.6 % for 2 %\ntofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib\nBID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference\nvs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 %\ntofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus\nwas significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting\nDay 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced\nserious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nConclusions: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater\nefficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.
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