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.
| Original language | English |
|---|---|
| Journal | British Journal of Dermatology |
| Volume | 180 |
| Issue number | 1 |
| Pages (from-to) | 67-75 |
| Number of pages | 9 |
| ISSN | 0007-0963 |
| DOIs | |
| Publication status | Published - 01.2019 |
Funding
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.44 Conflicts of interest: B.E.S. has been a consultant and advisory board member for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene, Cutanea-Maruho, Dermira, Janssen, LEO Pharma, Lilly, Medac, Novartis, Pfizer Inc., Sun Pharma, UCB and Valeant (honoraria for all); an investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Novartis, Janssen, Lilly, Merck, Pfizer Inc. and Sun Pharma (payments to the University of Connecticut, not to B.E.S.) and scientific director for the CORRONA Psoriasis Registry (consulting fee); and received grant support to the University of Connecticut for a fellowship programme from AbbVie and Janssen (payments to the University of Connecticut, not to B.E.S.). A.B.G. has been a consultant or advisory board member for AbbVie, Aclaris, Actelion, Akros, Allergan, Amgen, Amicus, Astellas, Baxalta, Beiersdorf, Bristol-Myers Squibb, Canfite, Catabasis, Celgene, Centocor (Janssen), Coronado, Crescendo Bioscience, CSL Behring Biotherapies for Life, Der-mipsor, Dermira, Genentech, GlaxoSmithKline, Incyte, Karyo-pharm, Kineta One, KPI Therapeutics, Lilly, Meiji Seika Pharma Co., Mitsubishi Tanabe Pharma Development America, Novartis, Novo Nordisk, Pfizer Inc., Reddy Labs, Takeda, TEVA, UCB, Valeant, Vertex and Xenoport; and received research or educational grants from Janssen Incyte. P.C.M.vdK. has been a consultant for Abbott, Almirall, Amgen, Celgene, Centocor, Galderma, Janssen-Cilag, LEO Pharma, Lilly, Mit-subishi, Novartis, Pfizer Inc., Philips and Sandoz; and an investigator for AbbVie, Amgen, Basilea, Janssen-Cilag, LEO Pharma, Lilly, Pfizer Inc. and Philips. L.P. has been an advisory board member, speaker, consultant or investigator for AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer Inc., Regeneron, Roche, Sandoz, Sanofi and Sun Pharma. H.B. has been an advisory board member, speaker, consultant or investigator for AbbVie, Amgen, Anaptysbio, Baxalta, Bayer, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer Inc., Pierre Fabre, Sun Pharma and Takeda. E.C. has been a speaker, consultant or investigator for AbbVie, Galderma, Lilly, Merck, Novartis, Pfizer Inc. and Roche. S.I. has been a speaker or consultant for AbbVie, Celgene, Janssen, Lilly, Maruho, Novartis, Pfizer Inc. and Torii Yakuhin. D.T. has received research support from AbbVie, Almirall, Amgen, Astellas, Biogen Idec, Boehringer Ingelheim, Celgene, Dignity, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Lilly, MSD, Novartis, Pfizer Inc., Regeneron and Sandoz; has received honoraria from AbbVie, Biogen Idec, Celgene, Janssen, LEO Pharma, Novartis and Pfizer Inc.; has been a consultant for AbbVie, Celgene, Dignity, Galapagos, Novartis, Pfizer Inc. and Xenoport; and has been on scientific advisory boards for Abb-Vie, Celgene, GlaxoSmithKline, Janssen, LEO Pharma, Lilly, Novartis, Pfizer Inc., Sandoz and Sanofi. H.T., H.V., P.G., V.F. and R.W. are employees and shareholders of Pfizer Inc. M.K. was an employee of Pfizer Inc. at the time the studies were conducted.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
