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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
Author(s) -
Mamolo C.,
Harness J.,
Tan H.,
Menter A.
Publication year - 2014
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.12081
Subject(s) - tofacitinib , medicine , janus kinase inhibitor , placebo , dermatology life quality index , psoriasis , quality of life (healthcare) , psoriasis area and severity index , randomized controlled trial , gastroenterology , dermatology , pathology , rheumatoid arthritis , alternative medicine , nursing
Background Psoriasis is a chronic, inflammatory skin disease with a significant impact on health–related quality of life ( HRQ oL). 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 PRO s 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 Pt GA vs. placebo. Conclusion In patients with moderate–to–severe chronic plaque psoriasis, short‐term (12–week) treatment with oral twice‐daily tofacitinib improves HRQ oL outcomes and patient assessment of disease severity and symptoms, with an early onset noted.