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Inflammatory bowel disease among patients with psoriasis treated with ixekizumab: A presentation of adjudicated data from an integrated database of 7 randomized controlled and uncontrolled trials - 18/04/17

Doi : 10.1016/j.jaad.2016.10.027 
Kristian Reich, MD a, Craig Leonardi, MD, PC b, Richard G. Langley, MD, FRCPC c, Richard B. Warren, MBChB (Hons), PhD d, Hervé Bachelez, MD, PhD e, Ricardo Romiti, MD f, Mamitaro Ohtsuki, MD, PhD g, Wen Xu, PhD h, Nayan Acharya, MBBS, MRCP, MFPM h, Kathleen Solotkin, MSN h, Jean-Frederic Colombel, MD i, Dana S. Hardin, MD h,
a Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany 
b Department of Dermatology, Saint Louis University School of Medicine, Saint Louis, Missouri 
c Division of Clinical Dermatology and Cutaneous Science, Dallhousie University, Halifax, Nova Scotia, Canada 
d Dermatology Centre, Salford Royal Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom 
e Sorbonne Paris Cité Université Paris Diderot, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherché 1163, Imagine Institute, Necker Hospital, Paris, France 
f Department of Dermatology Hospital das Clínicas University of São Paulo, São Paulo, Brazil 
g Jichi Medical University, Shimotsuke, Japan 
h Eli Lilly and Company, Indianapolis, Indiana 
i Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York 

Reprint requests: Dana S. Hardin, MD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285.Eli Lilly and CompanyLilly Corporate CenterIndianapolisIN46285

Abstract

Background

Inflammatory bowel disease (IBD) occurs more frequently in patients with psoriasis. The 2 diseases have significant genetic overlap, but the pathogenesis underlying their co-occurrence is unknown.

Objective

We sought to report adjudicated IBD cases (Crohn's disease [CD] and ulcerative colitis [UC]) in patients exposed to ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A.

Methods

Adverse events (AEs) integrated from 7 randomized controlled and uncontrolled trials were analyzed for the controlled induction period, controlled maintenance period, and all ixekizumab-treated patients. Suspected IBD cases were reviewed by blinded external experts using internationally recognized criteria (Registre Epidemiologique des Maladies de l'Appareil Digestif registry).

Results

In all, 4209 patients (6480 patient-exposure years) were exposed to ixekizumab. Suspected CD (N = 12) or UC (N = 17) AEs were reported; 19 were adjudicated as definite/probable IBD (CD, N = 7, incidence rate = 1.1/1000 patient-exposure years; UC, N = 12, incidence rate = 1.9/1000 patient-exposure years). Among these, 3 occurred during induction (CD, N = 1; UC, N = 2) and 7 during maintenance (CD, N = 4; UC, N = 3). Twelve of 16 patients with reported IBD history have not had an IBD treatment-emergent AE/serious AE to date.

Limitations

Clinical review (adjudication) was not prespecified. AE data collected post-hoc may have been limited by length of time from occurrence.

Conclusion

From an integrated database of 7 ixekizumab psoriasis trials, CD and UC cases were uncommon (<1%).

Le texte complet de cet article est disponible en PDF.

Key words : biologic therapy, Crohn's disease, inflammatory bowel disease, interleukin-17 antagonists, ixekizumab, psoriasis, ulcerative colitis

Abbreviations used : AE, CD, EPIMAD, IBD, IL, SAE, TEAE, UC


Plan


 Funding for the clinical trials and this publication provided by Eli Lilly and Company.
 Disclosure: Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by Abbvie, Amgen, Biogen, Boehringer-Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Eli Lilly and Company, Medac, Merck Sharp & Dohme Corp, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Leonardi has been a consultant/advisory board member for Abbvie, Amgen, Boehringer-Ingelheim, Dermira, Eli Lilly and Company, Janssen, LEO Pharma, Pfizer, Sandoz, and VCB; an investigator for Actavis, Abbvie, Amgen, Celgene, Coherus, Dermira, Eli Lilly and Company, Galderma, Janssen, Merck, Pfizer, Sandoz, Stiefel, LEO Pharma, Novartis, and Wyeth; and a member of the speaker's bureau of Abbvie, Celgene, and Novartis. Dr Langley has been a consultant/advisory board member/paid speaker for Abbvie, Amgen, Celgene, Centocor, Eli Lilly and Company, Novartis, and Pfizer. Dr Warren has acted as a speaker and/or consultant for Abbvie, Amgen, Allmirall, Pfizer, Novartis, Eli Lilly and Company, LEO Pharma, Janssen, and Xenoport. Dr Bachelez has served on an advisory board and/or as a consult for Abbvie, Amgen, Baxalta, Boehringer-Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly and Company, MSD, Novartis, Pfizer, Pierre Fabre, Sun Pharma, and UCB Pharma; and has been a speaker for Abbvie, Amgen, Bayer, Boehringer-Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly and Company, Novartis, Pfizer, Sun Pharma, and UCB Pharma. Dr Romiti has served on an advisory board and/or as a consult for Abbvie, Galderma, Janssen, LEO Pharma, Eli Lilly and Company, MSD, Novartis, Pfizer, and UCB Pharma; and has been a speaker for Abbvie, Janssen, LEO Pharma, Eli Lilly and Company, MSD, Novartis, Pfizer, and UCB Pharma. Dr Ohtsuki has received honoraria as a consultant and/or advisory board member and/or acted as paid speaker and/or participated in clinical trials sponsored by Abbvie, Boehringer-Ingelheim, Celgene, Eisai, Janssen, Kyowa-Kirin, LEO Pharma, Eli Lilly and Company, Maruho, Novartis, Pfizer, and Tanabe-Mitsubishi. Dr Colombel has served as a consultant or advisory board member for Abbvie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen and Janssen, Eli Lilly and Company, Medimmune, Merck & Co, Pfizer, Protagonist, Second Genome, Seres, Shire, Takeda, and Theradiag; has been a speaker for Abbvie and Ferring; has been a member of the speaker's bureau for Amgen; and has stock options with Intestinal Biotech Development and Genfit. Drs Xu, Acharya, and Hardin, and Ms Solotkin are employees of and hold stock in Eli Lilly and Company.
 Some data from this article were presented at the American Academy of Dermatology annual meeting, Washington, DC, March 6, 2016.


© 2016  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 76 - N° 3

P. 441 - mars 2017 Retour au numéro
Article précédent Article précédent
  • Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
  • Bruce Strober, Craig Leonardi, Kim A. Papp, Ulrich Mrowietz, Mamitaro Ohtsuki, Robert Bissonnette, Laura K. Ferris, Carle Paul, Mark Lebwohl, Daniel K. Braun, Lotus Mallbris, Stefan Wilhelm, Wen Xu, Anders Ljungberg, Nayan Acharya, Kristian Reich
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