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Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study - 14/04/16

Doi : 10.1016/j.jaad.2016.01.013 
Kim A. Papp, MD, PhD a, James G. Krueger, MD, PhD b, Steven R. Feldman, MD, PhD c, Richard G. Langley, MD d, Diamant Thaci, MD e, Hideshi Torii, MD, PhD f, Stephen Tyring, MD, PhD g, Robert Wolk, MD, PhD, DSc h, Annie Gardner, MS i, Charles Mebus, PhD h, Huaming Tan, PhD h, Yingchun Luo, PhD h, Pankaj Gupta, PhD h, Lotus Mallbris, MD, PhD j, Svitlana Tatulych, MD h,
a Probity Medical Research and K. Papp Clinical Research Inc, Waterloo, Ontario, Canada 
b Rockefeller University, New York, New York 
c Wake Forest Baptist Health, Winston-Salem, North Carolina 
d Dalhousie University, Halifax, Nova Scotia, Canada 
e Comprehensive Center for Inflammation Research, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany 
f Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan 
g Department of Dermatology, University of Texas Medical School, Houston, Texas 
h Pfizer Inc, Groton, Connecticut 
i Pfizer Inc, Cambridge, Massachusetts 
j Dermatology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden 

Reprint requests: Svitlana Tatulych, MD, Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340.Pfizer Inc558 Eastern Point RdGrotonCT06340

Abstract

Background

Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis.

Objectives

We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis.

Methods

Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID.

Results

At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure.

Limitations

There was no dose comparison beyond week 52.

Conclusions

Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.

Le texte complet de cet article est disponible en PDF.

Key words : efficacy, Janus kinase inhibitor, long-term, psoriasis, randomized controlled trial, safety, tofacitinib

Abbreviations used : AE, BID, CI, HZ, IR, LTE, NMSC, OPT, PASI, PASI75, PASI90, PGA, SAE, UV


Plan


 Sponsored by Pfizer Inc. Medical writing support was provided by Alice Palmer, PhD, of Complete Medical Communications and funded by Pfizer Inc.
 Disclosure: Dr Papp has participated in advisory boards or panels for AbbVie, Allergan, Amgen, Apotex, Astellas, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, Genentech, Janssen, Leo, Merck, Merck Serono, Novartis, Pfizer Inc, Stiefel, and UCB; has acted as a consultant for AbbVie, Allergan, Amgen, Astellas, Baxter, Boehringer Ingelheim, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Merck, Merck Serono, Novartis, Pfizer Inc, Regeneron, Stiefel, Takeda, and UCB; and has received grants or is an investigator for AbbVie, Allergan, Amgen, Anacor, Astellas, Boehringer Ingelheim, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen, Leo, Merck, Merck Serono, Novartis, Pfizer Inc, Regeneron, Stiefel, Takeda, and UCB. Dr Krueger has received grants and consultancy fees from Pfizer Inc. Dr Feldman has participated in advisory boards or panels for AbbVie, Novartis, and Pfizer Inc; has acted as a consultant for AbbVie, Amgen, Celgene, Galderma, Merck, Novartis, and Pfizer Inc; and has participated in speakers' bureaus for Celgene, Galderma, and Janssen. Dr Langley has participated in advisory boards or panels and acted as a consultant for, and received research grants from, AbbVie, Amgen, Celgene, Centocor, Eli Lilly, Novartis, and Pfizer Inc; and has participated in speakers' bureaus for AbbVie, Amgen, Celgene, Centocor, Novartis, and Pfizer Inc. Dr Thaci has acted as a consultant, investigator, and speaker for, and has participated in advisory boards for, AbbVie, Amgen, Biogen Idec, Celgene, Eli Lilly, Janssen-Cilag, Leo, MSD, Novartis, Pfizer Inc, Regeneron, and Sanofi; and has received research/educational grants from AbbVie and Pfizer Inc. Dr Torii has acted as a consultant for AbbVie, Janssen, Mitsubishi Tanabe Pharma, Novartis, and Pfizer Inc. Dr Tyring has conducted research sponsored by Pfizer Inc. Drs Wolk, Mebus, Tan, Luo, Gupta, and Tatulych and Ms Gardner are employees and shareholders of Pfizer Inc. Dr Mallbris was an employee of Pfizer Inc at the time of the analysis.


© 2016  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 74 - N° 5

P. 841-850 - mai 2016 Retour au numéro
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