Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: pooled analysis across six clinical trials
Por:
Strober, BE, Gottlieb, AB, van de Kerkhof, PCM, Puig, L, Bachelez, H, Chouela, E, Imafuku, S, Thaci, D, Tan, H, Valdez, H, Gupta, P, Kaur, M, Frajzyngier, V, Wolk, R
Publicada:
1 ene 2019
Resumen:
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.
Filiaciones:
Strober, BE:
Univ Connecticut, Ctr Hlth, Dept Dermatol, Farmington, CT USA
Prob Med Res, Waterloo, ON, Canada
Gottlieb, AB:
Metropolitan Hosp, New York Med Coll, New York, NY USA
van de Kerkhof, PCM:
Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands
Puig, L:
Univ Autonoma Barcelona, Sch Med, Hosp Santa Creu & St Pau, Dept Dermatol, Barcelona, Spain
Bachelez, H:
Univ Paris Diderot, Hop St Louis, AP HP, Sorbonne Paris Cite,Serv Dermatol, Paris, France
Chouela, E:
Univ Buenos Aires, Buenos Aires, DF, Argentina
Imafuku, S:
Fukuoka Univ, Dept Dermatol, Fac Med, Fukuoka, Fukuoka, Japan
Thaci, D:
Univ Hosp Schleswig Holstein, Comprehens Ctr Inflammat Med, Campus Lubeck, Lubeck, Germany
Tan, H:
Pfizer Inc, Groton, CT 06340 USA
Valdez, H:
Pfizer Inc, Groton, CT 06340 USA
Gupta, P:
Pfizer Inc, Groton, CT 06340 USA
Kaur, M:
Pfizer Inc, Collegeville, PA USA
Frajzyngier, V:
Pfizer Inc, New York, NY USA
Wolk, R:
Pfizer Inc, Groton, CT 06340 USA
Green Published, Hybrid Gold
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