title: 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.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: C
authors.initials: C
authors.lastname: Mamolo
authors.affiliation: Pfizer Inc, Groton, CT, USA.|Novartis Pharma AG, Basel, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Harness
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: H
authors.initials: H
authors.lastname: Tan
authors.affiliation: Baylor Research Institute, Dallas, TX, USA.
authors.forename: A
authors.initials: A
authors.lastname: Menter
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053616:Janus Kinase 3 / Q000037:antagonists & inhibitors; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D053616:Janus Kinase 3