Article

4 Iconography
Access to the text (HTML) Access to the text (HTML)
PDF Access to the PDF text
Advertising


Access to the full text of this article requires a subscription.
  • If you are a subscriber, please sign in 'My Account' at the top right of the screen.

  • If you want to subscribe to this journal, see our rates



Journal of the American Academy of Dermatology
Volume 71, n° 6
pages 1176-1182 (décembre 2014)
Doi : 10.1016/j.jaad.2014.07.048
accepted : 27 July 2014
Original Articles

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
 

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.

The full text of this article is available in PDF format.

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



 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.@@#104156@@
EM-CONSULTE.COM is registrered at the CNIL, déclaration n° 1286925.
As per the Law relating to information storage and personal integrity, you have the right to oppose (art 26 of that law), access (art 34 of that law) and rectify (art 36 of that law) your personal data. You may thus request that your data, should it be inaccurate, incomplete, unclear, outdated, not be used or stored, be corrected, clarified, updated or deleted.
Personal information regarding our website's visitors, including their identity, is confidential.
The owners of this website hereby guarantee to respect the legal confidentiality conditions, applicable in France, and not to disclose this data to third parties.
Close
Article Outline