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
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. |
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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. |
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Some data from this article were presented at the American Academy of Dermatology annual meeting, Washington, DC, March 6, 2016. |
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