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A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis - 15/11/14

Doi : 10.1016/j.jaad.2014.07.048 
Kenneth B. Gordon, MD a, , Craig L. Leonardi, MD b, Mark Lebwohl, MD c, Andrew Blauvelt, MD, MBA d, Gregory S. Cameron, PhD e, Daniel Braun, MD, PhD e, Janelle Erickson, PhD e, Michael Heffernan, MD e
a Northwestern University, Feinberg School of Medicine, Chicago, Illinois 
b Saint Louis University School of Medicine, St Louis, Missouri 
c Icahn School of Medicine at Mount Sinai, New York, New York 
d Oregon Medical Research Center, Portland, Oregon 
e Eli Lilly and Company, Indianapolis, Indiana 

Reprint requests: Kenneth B. Gordon, MD, Department of Dermatology, Northwestern University, NMH/Galter Room 19-150, 675 N Saint Clair, Chicago, IL 60611.

Abstract

Background

Patients with moderate to severe plaque psoriasis demonstrated positive responses to ixekizumab, an anti-interleukin-17A monoclonal antibody, in a phase-II, randomized, placebo-controlled trial.

Objective

We sought to evaluate long-term efficacy and safety of ixekizumab.

Methods

After receiving 10, 25, 75, or 150 mg of ixekizumab or placebo during randomized, placebo-controlled trial, patients with less than 75% improvement from baseline on the Psoriasis Area and Severity Index (PASI) score (PASI75) entered open-label extension (OLE); patients with PASI75 or higher entered a treatment-free period (weeks 20-32), then entered OLE after meeting response criteria. During OLE, patients received 120 mg of subcutaneous ixekizumab every 4 weeks.

Results

In all, 120 patients entered OLE; 103 completed 52 weeks or more of treatment. Overall, 77% of patients achieved PASI75 at week 52 (nonresponder imputation). Patients who responded to treatment in the randomized, placebo-controlled trial maintained a high-level response by week 52 of OLE (PASI75 = 95%; 90% improvement from baseline on the PASI score = 94%; 100% improvement from baseline on the PASI score = 82%). Irrespective of dose in the randomized, placebo-controlled trial, each group had similar response rates at week 52 of OLE. The exposure-adjusted incidence rate for adverse events was 0.47 and for serious adverse events was 0.06 per patient-year during OLE.

Limitations

No control group, small sample sizes, and bias toward retention of patients with positive responses limit interpretation.

Conclusion

A high proportion of patients responded to ixekizumab therapy and maintained clinical responses over 1 year of treatment with no unexpected safety signals.

Le texte complet de cet article est disponible en PDF.

Key words : interleukin 17, ixekizumab, long-term, monoclonal antibodies, open label, psoriasis, 1 year

Abbreviations used : AE, NRI, OLE, PASI, PASI75, PASI90, PASI100, RCT, SAE, sPGA


Plan


 Supported by Eli Lilly and Company.
 Disclosure: Dr Gordon is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Centocor, Merck, Eli Lilly and Company, Novartis, and Pfizer. Dr Leonardi is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Celgene Corp, Centocor, Eli Lilly and Company, Galderma, Genentech, Genzyme, GlaxoSmithKline, Incyte, Novartis, Novo Nordisk, Pfizer, Schering-Plough, Sirtris, Stiefel, Vascular Biogenics, and Wyeth, and is a speaker for AbbVie Inc. Dr Lebwohl has been a consultant and/or investigator for Inbios, Coronado Biosciences, AbbVie Inc, Valeant, Taro, Pfizer, UCB Pharma, Forward Pharma, DermiPsor, Galderma, Ranbaxy, Novartis, Dermira, Merz, Merck, LEO Pharma Inc, Janssen-Biotech, GlaxoSmithKline, Eli Lilly and Company, Celgene Corp, Can-Fite Biopharma Ltd, Anacor Pharmaceuticals Inc, and Amgen Inc. Dr Blauvelt is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Boehringer Ingelheim, Celgene Corp, Janssen Biotech, Merck, Novartis, Pfizer, and Eli Lilly and Company. Drs Cameron, Braun, Erickson, and Heffernan are employees and shareholders of Eli Lilly and Company.


© 2014  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 71 - N° 6

P. 1176-1182 - décembre 2014 Retour au numéro
Article précédent Article précédent
  • Comparative effectiveness of less commonly used systemic monotherapies and common combination therapies for moderate to severe psoriasis in the clinical setting
  • Junko Takeshita, Shuwei Wang, Daniel B. Shin, Kristina Callis Duffin, Gerald G. Krueger, Robert E. Kalb, Jamie D. Weisman, Brian R. Sperber, Michael B. Stierstorfer, Bruce A. Brod, Stephen M. Schleicher, Andrew D. Robertson, Kristin A. Linn, Russell T. Shinohara, Andrea B. Troxel, Abby S. Van Voorhees, Joel M. Gelfand
| Article suivant Article suivant
  • Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment
  • Kim Papp, Craig Leonardi, Alan Menter, Elizabeth H.Z. Thompson, Cassandra E. Milmont, Greg Kricorian, Ajay Nirula, Paul Klekotka

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