B E Strober1,2, A B Gottlieb3, P C M van de Kerkhof4, L Puig5, H Bachelez6, E Chouela7, S Imafuku8, D Thaçi9, H Tan10, H Valdez10, P Gupta10, M Kaur11, V Frajzyngier12, R Wolk10. 1. Department of Dermatology, University of Connecticut Health Center, Farmington, CT, U.S.A. 2. Probity Medical Research, Waterloo, ON, Canada. 3. New York Medical College at Metropolitan Hospital, New York, NY, U.S.A. 4. Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. 5. Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona Medical School, Barcelona, Spain. 6. Sorbonne Paris Cité Université Paris Diderot, Assistance Publique-Hôpitaux de Paris, Service de Dermatologie, Hôpital Saint-Louis, Paris, France. 7. Universidad de Buenos Aires, Buenos Aires, Argentina. 8. Department of Dermatology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan. 9. Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. 10. Pfizer Inc., Groton, CT, U.S.A. 11. Pfizer Inc., Collegeville, PA, U.S.A. 12. Pfizer Inc., New York, NY, U.S.A.
Abstract
BACKGROUND: Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate-to-severe chronic plaque psoriasis. OBJECTIVES: To consider the benefits and risks of tofacitinib in patients with moderate-to-severe psoriasis. METHODS: Data were pooled from one phase II, four phase III and one long-term extension study comprising 5204 patient-years of tofacitinib treatment. Efficacy end points included patients achieving Physician's Global Assessments of 'clear' or 'almost clear', ≥ 75% and ≥ 90% reduction in Psoriasis Area and Severity Index (coprimary end points) and improvements in Dermatology Life Quality Index score, Hospital Anxiety and Depression Scale depression score and Itch Severity Item score, at weeks 16 and 52. Safety data were summarized for 3 years of tofacitinib exposure. RESULTS: Tofacitinib 5 and 10 mg twice daily (BID) showed superiority over placebo for all efficacy end points at week 16, with response maintained for 52 weeks of continued treatment. Tofacitinib improved patients' quality of life and was well tolerated. Rates of safety events of interest (except herpes zoster) were similar to those in the published literature and healthcare databases for other systemic psoriasis therapies. Tofacitinib 10 mg BID demonstrated greater efficacy than 5 mg BID. CONCLUSIONS: Tofacitinib has a benefit-risk profile in moderate-to-severe psoriasis consistent with that of other systemic treatments.
BACKGROUND: Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate-to-severe chronic plaque psoriasis. OBJECTIVES: To consider the benefits and risks of tofacitinib in patients with moderate-to-severe psoriasis. METHODS: Data were pooled from one phase II, four phase III and one long-term extension study comprising 5204 patient-years of tofacitinib treatment. Efficacy end points included patients achieving Physician's Global Assessments of 'clear' or 'almost clear', ≥ 75% and ≥ 90% reduction in Psoriasis Area and Severity Index (coprimary end points) and improvements in Dermatology Life Quality Index score, Hospital Anxiety and Depression Scale depression score and Itch Severity Item score, at weeks 16 and 52. Safety data were summarized for 3 years of tofacitinib exposure. RESULTS:Tofacitinib 5 and 10 mg twice daily (BID) showed superiority over placebo for all efficacy end points at week 16, with response maintained for 52 weeks of continued treatment. Tofacitinib improved patients' quality of life and was well tolerated. Rates of safety events of interest (except herpes zoster) were similar to those in the published literature and healthcare databases for other systemic psoriasis therapies. Tofacitinib 10 mg BID demonstrated greater efficacy than 5 mg BID. CONCLUSIONS:Tofacitinib has a benefit-risk profile in moderate-to-severe psoriasis consistent with that of other systemic treatments.
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