ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1522

Inflammatory Bowel Disease and Anterior Uveitis in Patients Treated with Ixekizumab for Radiographic Axial Spondyloarthritis: Results from Two Phase 3 Studies Through 52 Weeks

Sergio Schwartzman1, Atul Deodhar 2, Andris Kronbergs 3, Silvia Santisteban 3, Sandra Garces 3, David Sandoval 3, Jeffrey Lisse 3, Fangyi Zhao 3, Denis Poddubnyy 4 and James Rosenbaum 5, 1The Hospital for Special Surgery, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY, 2Oregon Health & Science University, Portland, OR, 3Eli Lilly and Company, Indianapolis, IN, 4Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, Berlin, Germany, 5Departments of Ophthalmology, Medicine, and Cell Biology, Oregon Health and Science University, Portland, OR

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Radiographic axial spondyloarthritis (r-axSpA) is a chronic inflammatory disease involving the axial skeleton; inflammatory bowel disease (IBD) and acute anterior uveitis (AAU) are common extra-articular manifestations. IBD has been reported in 3–10% of ankylosing spondylitis (AS) patients (pts).1 Exposure-adjusted incidence rates (EAIRs) of IBD in AS pts treated with TNF inhibitors (TNFi) have been reported as 0.2–2.3 per 100 person years (PY)3. The frequency of AAU in AS has been reported as 33%2 and the EAIR of AAU has been reported as 2.6–3.5 per 100 PY.4

Ixekizumab (IXE) is a high-affinity mAb targeting IL-17A with established efficacy and safety in pts with r-axSpA.5,6 We summarize IBD and AAU cases reported from 2 pivotal studies of IXE in r-axSpA.

Methods: COAST-V (NCT02696785) and COAST-W (NCT02696798) are phase 3, randomized, controlled studies in pts with r-axSpA naïve to biological DMARDs (bDMARDs) or pts who previously failed 1 or 2 TNFi (TNFi-experienced), respectively. Full study designs have been described previously5,6. Pts with a history of IBD or AAU were not excluded if these conditions were stable. At each study visit, pts were evaluated for any symptoms of AAU and IBD. AAU events were confirmed by an ophthalmologist. IBD events were adjudicated following Registre Epidemiologique des Maladies de l’Appareil Digestif (EPIMAD) criteria. EAIRs were calculated by the number of patients experiencing these events per 100 PY.

Results: Across both studies, 2.1% of pts had a history of IBD, and there were 4 cases of Crohn’s disease (CD), 2 cases of ulcerative colitis (UC), and 2 cases of IBD not otherwise specified (IBD NOS) among patients treated with IXE and 1 case of UC on placebo. Most patients who had events of IBD had a prior diagnosis of IBD or prior gastrointestinal history potentially indicative of IBD. EAIRs for CD, UC, and IBD NOS were 0.8, 0.4, and 0.4 per 100 PY, respectively (Table 1). Four patients permanently discontinued IXE treatment due to IBD.

Across both studies, 20.1% of pts had a history of AAU, and 20 pts reported events of AAU, 15 of those had a prior history of AAU. One case resulted in drug interruption, and 1 case resulted in permanent discontinuation of IXE treatment due to AAU. The EAIR for AAU was 3.9 per 100 PY (Table 1).

Conclusion: In IXE-treated r-axSpA pts, frequencies of IBD and AAU were in the range of those seen in AS pts.1, 2 EAIRs of IBD were numerically similar to those seen in TNFi-treated AS pts for both studies. More and longer-term data are required to better understand the incidence rates of IBD and AAU in r-axSpA pts treated with IXE.

1. Sieper S, Braun J. Clinician’s Manual on Ankylosing Spondylitis. London: Springer Healthcare; 2009: 23.
2. Zeboulon N, et al. Ann Rheum Dis. 2008; 67(7):955-9.
3. Braun J, et al. Arthritis Rheum. 2007;57(4):639–47.
4. Deodhar A, et al. Ann Rheum Dis. 2018;77:999.
5. van der Heijde D, et al. Lancet. 2018;392(10163):2441–2451.
6. Deodhar A, et al. Arthritis Rheumatol. 2019; 71(4):599–611.

AAU=acute anterior uveitis; CD=Crohn’s disease; EAIR=exposure-adjusted incidence rate per 100 patient years; EPIMAD=Registre Epidemiologique des Maladies de l’Appareil Digestif; IBD=inflammatory bowel disease; n=number of patients in the specified category; NOS=not otherwise specified; UC=ulcerative colitis.

Disclosure: S. Schwartzman, AbbVie, 5, 8, Amgen, 4, Boston Scientific, 4, Crescendo Bioscience, 5, Dermtech, 5, Eli Lilly and Company, 5, 8, Genentech, 8, Gilead Sciences, 4, 5, Janssen Pharmaceutica, 5, 8, Janssen Research & Development, LLC, 2, Medtronic, 4, Myriad Genetics, 5, 9, National Psoriasis Foundation, 6, Novartis, 5, 8, Pfizer, 4, 8, Regeneron, 5, 8, Samsung, 5, Sanofi, 5, 8, UCB, 5, 8; A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9; A. Kronbergs, Eli Lilly and Company, 1, 3, 4; S. Santisteban, Eli Lilly and Company, 1, 3; S. Garces, Eli Lilly and Company, 1, 3; D. Sandoval, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; J. Lisse, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; F. Zhao, Eli Lilly, 1, 3, 4, Eli Lilly and Company, 1, 3, 4; D. Poddubnyy, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, BMS, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Eli Lilly and Company, 2, 5, 8, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 5, 8, UCB, 5, 8; J. Rosenbaum, Pfizer, 2, UpToDate, 7, AbbVie, 5, Genentech, 5, Roche, 5, Novartis, 5, Horizon, 5, UCB, 5, Gilead Sciences, 5, Santen, 5, Eyevensys, 5, Janssen Pharmaceutica, 5.

To cite this abstract in AMA style:

Schwartzman S, Deodhar A, Kronbergs A, Santisteban S, Garces S, Sandoval D, Lisse J, Zhao F, Poddubnyy D, Rosenbaum J. Inflammatory Bowel Disease and Anterior Uveitis in Patients Treated with Ixekizumab for Radiographic Axial Spondyloarthritis: Results from Two Phase 3 Studies Through 52 Weeks [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/inflammatory-bowel-disease-and-anterior-uveitis-in-patients-treated-with-ixekizumab-for-radiographic-axial-spondyloarthritis-results-from-two-phase-3-studies-through-52-weeks/. Accessed .

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