Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, improves patient-reported outcomes in a phase 2b, randomized, double-blind, placebo-controlled study in patients with moderate-to-severe psoriasis


  • Conflict of interest

    CM and HT are employees of Pfizer Inc.; JH was a full-time employee of Pfizer Inc. during the conduct and reporting of the study and now works at Novartis Pharma AG, Basel, Switzerland. AM has been on the Advisory Board (A), been a consultant to (C), been an investigator for (I), been a speaker for (S), obtained a research grant from (G) or obtained honoraria from (H) the following 16 groups: Abbott (A, C, I, S, G, H), Allergan (I, G), Amgen (A, C, I, S, G, H), Astellas (A, C, I, S, G, H), Asubio (I, G), Celgene (I, G), Centocor (A, C, I, S, G, H), DUSA (I, G), Eli Lilly (C, I, G), Galderma (A, C, S, H), Genentech (A, C, I, S, G, H), Novartis (I, G), Novo Nordisk (I, G), Pfizer Inc. (I, G), Promius (I, G), Stiefel (C, I, G, H), Syntrix Biosystems (I, G), Warner Chilcott (A, C, I, S, H) and Wyeth (A, C, I, S, H)

  • Funding sources

    This study was funded by Pfizer Inc.



Psoriasis is a chronic, inflammatory skin disease with a significant impact on health–related quality of life (HRQoL). Tofacitinib (CP-690,550) is a novel, oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator.


This Phase 2b study assessed three tofacitinib dosage regimens vs. placebo to characterize the efficacy and safety of tofacitinib in patients with moderate–to-severe chronic plaque psoriasis. We report the patient-reported outcome (PRO) data.


A total of 197 patients were randomized to tofacitinib 2, 5, 15 mg twice daily or placebo for 12 weeks. Six PRO questionnaires were completed during the study: Dermatology Life Quality Index, Itch Severity Score (ISS), Short Form-36 questionnaire, version 2 (SF-36), Pain/Discomfort Assessment (PDA), Patient Satisfaction with Study Medication (PSSM) item and Patient Global Assessment of psoriasis.


Treatment with tofacitinib resulted in significant, dose-dependent improvements in several PROs vs. placebo from week 2 onwards. At week 12, least squares mean changes from baseline for Dermatology life quality index, ISS and SF-36 mental component scores were significantly greater for all active drug arms vs. placebo (P < 0.05), and significantly greater for tofacitinib 5 and 15 mg for SF-36 physical component scores vs. placebo (P < 0.05). At week 12, all dose groups had significantly greater numbers of patients reporting ‘Clear’ or ‘Almost clear’ on the PtGA vs. placebo.


In patients with moderate–to–severe chronic plaque psoriasis, short-term (12–week) treatment with oral twice-daily tofacitinib improves HRQoL outcomes and patient assessment of disease severity and symptoms, with an early onset noted.