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Journal of the American Academy of Dermatology
Volume 77, n° 5
pages 855-862 (novembre 2017)
Doi : 10.1016/j.jaad.2017.06.153
accepted : 26 June 2017
Original Articles

Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3)
 

Andrew Blauvelt, MD, MBA a, , Melinda Gooderham, MD, MSc b, Lars Iversen, MD, DMSc c, Susan Ball, PhD d, Lu Zhang, MS d, Noah O. Agada, MD d, Kristian Reich, MD e
a Oregon Medical Research Center, Portland, Oregon 
b Queen's University, SKiN Centre for Dermatology, Peterborough, Canada 
c Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark 
d Eli Lilly and Company, Indianapolis, Indiana 
e Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany 

Reprint requests: Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, 9495 SW Locus St, Suite G, Portland, OR 97223.Oregon Medical Research Center9495 SW Locus St, Suite GPortlandOR97223
Abstract
Background

Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, is efficacious in treating moderate-to-severe plaque psoriasis through 60 weeks.

Objective

To evaluate the efficacy and safety of ixekizumab through 108 weeks of treatment in UNCOVER-3.

Methods

Patients (N = 1346) were randomized 2:2:2:1 to 80 mg ixekizumab every 2 or 4 weeks, 50 mg etanercept twice weekly, or placebo. At week 12, patients switched to ixekizumab every 4 weeks during a long-term extension (LTE) period. Efficacy data were summarized using as-observed, multiple imputation (MI), and modified MI (mMI) methods.

Results

For patients (N = 385) receiving the recommended dose (ixekizumab every 2 weeks on weeks 0-12 and every 4 weeks during LTE), the 108-week as-observed, MI, and mMI response rates were 93.4%, 88.3%, and 83.6%, respectively, for patients achieving ≥75% improvement from baseline in the Psoriasis Area and Severity Index, and the 108-week as-observed, MI, and mMI response rates were 82.6%, 78.3%, and 74.1%, respectively, for patients with a static Physician's Global Assessment score of 0 or 1. During LTE, 1077 (84.5%) patients reported ≥1 treatment-emergent adverse event, and 85% were mild or moderate in severity. Discontinuation because of adverse events occurred in 6.4% of patients.

Limitations

There was no comparison treatment group after week 12.

Conclusion

Ixekizumab is well tolerated and demonstrates persistent efficacy through 108 weeks.

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

Key words : efficacy, interleukin 17, ixekizumab, long-term, psoriasis, safety, UNCOVER-3

Abbreviations used : AE, CI, IL, LTE, MI, mMI, NAPSI, NRI, PASI, PPASI, PSSI, sPGA, TEAE



 Funding sources: Supported by Eli Lilly and Company.
 Conflicts of interest: Dr Blauvelt has served as a scientific adviser and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GlaxoSmithKline, Janssen, Eli Lilly and Company, Merck Sharp & Dohme Corp, Novartis, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, UCB, and Valeant Pharmaceuticals International Inc and as a paid speaker for Eli Lilly and Company, Regeneron, and Sanofi Genzyme. Dr Gooderham has served as an investigator, speaker, and advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Novartis, and Pfizer and as an investigator for Akros, Dermira, UCB, and Coherus. Dr Iversen has been an investigator, paid speaker, consultant, and advisory board member for MSD, Pfizer, AbbVie, Janssen-Cilag, Eli Lilly and Company, Leo Pharma, and Novartis; has been a paid speaker, consultant, and advisory board member for Almirall; has been an investigator for Amgen; has been an advisory board member for UCB; and has received research and educational grants from Pfizer, AbbVie, Novartis, MSD, and Leo Pharma. Dr Reich has been an advisory board member, speaker, consultant, or has participated in clinical studies for AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo Pharma, Eli Lilly and Company, Medac, Merck Sharp & Dohme Corp, Novartis, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Ball, Dr Agada, and Ms Lu Zhang own stock in and are employees of Eli Lilly and Company.
 Portions of this work have previously been presented in the form of an abstract at the American Academy of Dermatology Annual Meeting, Orlando, Florida, March 5, 2017.



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