Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis : pooled analysis across six clinical trials
Strober, Bruce (Probity Medical Research)
Gottlieb, Alice B (New York Medical College at Metropolitan Hospital)
van de Kerkhof, P. C. M. (Radboud University Nijmegen Medical Centre)
Puig Sanz, Lluís. (Institut d'Investigació Biomèdica Sant Pau)
Bachelez, Hervé (Sorbonne Paris Cité Université Paris Diderot. Assistance Publique-Hôpitaux de Paris. Service de Dermatologie. Hôpital Saint-Louis)
Chouela, E. (Universidad de Buenos Aires)
Imafuku, S. (Department of Dermatology. Faculty of Medicine. Fukuoka University)
Thaçi, Diamant (Universitätsklinikum Schleswig-Holstein (Alemanya))
Tan, H. (Pfizer Inc.)
Valdez, H. (Pfizer Inc.)
Gupta, P. (Pfizer Inc.)
Kaur, M. (Pfizer Inc.)
Frajzyngier, V. (Pfizer Inc.)
Wolk, R. (Pfizer Inc.)
Universitat Autònoma de Barcelona

Fecha:	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.
Nota:	Altres ajuts: This study was funded by Pfizer Inc. The authors would like to thank Maryam Asgari and Charlie Quesenberry, principal investigators of the KPNC database cohort study, and Kevin Winthrop and Jeffrey Curtis, principal investigators of the Medicare database cohort. This study was supported by Pfizer Inc. Medical writing support under the guidance of the authors was provided by Sandrine M. Dupré, PhD, and Carole Evans, PhD, at and on behalf of Complete Medical Communications, Manchester, U.K., and was funded by Pfizer Inc., New York, NY, U.S.A., in accordance with the Good Publication Practice (GPP3) guidelines.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	British journal of dermatology, Vol. 180 Núm. 1 (january 2019) , p. 67-75, ISSN 1365-2133

DOI: 10.1111/bjd.17149
PMID: 30188571

9 p, 453.9 KB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut de Recerca Sant Pau
Artículos > Artículos de investigación
Artículos > Artículos publicados