IBD

49 - Long-Term Efficacy of Ustekinumab With and Without Concomitant Immunosuppressants for Crohn’s Disease: Results From IM-UNITI Long-Term Extension Through 2 Years

Tuesday, October 9
2:45 PM - 2:55 PM
Location: Terrace Ballroom 2-3 (level 400)

Category: IBD
Bruce E. Sands, MD, MS1, Brian Kramer, PhD2, Christopher Gasink, MD2, Douglas Jacobstein, MD3, Omoniyi J. Adedokun, MS, RPh3, Long-Long Gao, PhD2, Paul Rutgeerts, MD, PhD4, Subrata Ghosh, MD5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Janssen Scientific Affairs, LLC, Horsham, PA; 3Janssen Research & Development, LLC, Spring House, PA; 4University Hospital Gasthuisberg, Leuven, Vlaams-Brabant, Belgium; 5University of Birmingham, Birmingham, England, United Kingdom

Introduction: Ustekinumab (UST) is a fully human immunoglobulin G1 kappa mAB to human IL 12/23p40 approved for the treatment of moderate to severe active Crohn’s disease (CD). The continuing IM-UNITI long-term extension (LTE) evaluates the efficacy and safety of subcutaneous (SC) UST through approximately 5 years of treatment. Results through maintenance week 44 previously demonstrated no apparent benefit of concomitant immunosuppressant (IMM) use on efficacy, drug levels or immunogenicity of UST. Results through 2 years are reported herein.

Methods: 1281 patients entered the maintenance study, including 397 UST induction responders in the primary population (randomized to placebo (PBO) SC; n=133, UST 90mg SC q12w (q12w); n=132, or UST 90mg SC q8w (q8w); n=132). A one-time dose adjustment to UST 90mg SC q8w occurred in randomized patients who met loss of response (LOR) criteria between weeks 8 & 32. All patients completing week 44 were eligible to enter the LTE continuing the treatment they were on at week 44.  This analysis included the 82 patients on UST q8w from the primary population who did not meet LOR criteria for dose adjustment and entered the LTE. Clinical remission at each study visit, serum UST concentrations from maintenance weeks 44 to 92, and immunogenicity were assessed in patients taking vs. not taking concomitant IMMs.

Results: Baseline use of concomitant IMMs in the randomized UST q8w LTE population was 35.4% (29/82).  Patients that were not on IMMs at baseline (64.6%, 53/82), all remained off IMMs through week 92.    Rates of remission in the q8w group were not higher among patients with baseline IMM use and were similar through week 92 (Table 1). Furthermore, concomitant use of immunomodulators did not appear to have any notable or consistent effect on serum UST concentrations or antidrug- antibody formation at any timepoint examined (Table 1).

Discussion: Data through 2 years of UST treatment (90mg q8w maintenance) in the IM-UNITI LTE study suggest that concurrent use of immunomodulators does not increase remission efficacy. Further supporting the notion that concomitant use of IMM with UST is not necessary, no effect on serum UST concentrations or antidrug antibodies was seen across all timepoints, in contrast to findings with other biologic agents.

Table 1.

Disclosures:
Bruce Sands: Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support.
Brian Kramer: Janssen Scientific Affairs, LLC – Employee.
Christopher Gasink: Johnson and Johnson – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Douglas Jacobstein: Janssen Research and Development – Employee.
Omoniyi Adedokun: Janssen Research & Development, LLC – Employee.
Long-Long Gao: Johnson & Johnson – Employee.
Paul Rutgeerts: Jannsen Research & Development, LLC – Advisory Committee/Board Member, Grant/Research Support.
Subrata Ghosh: Janssen Research & Development, LLC – Advisory Committee/Board Member, Grant/Research Support.

Bruce E. Sands

Chief, Division of Gastroenterology
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai
New York, NY, US

Dr. Bruce Sands is the Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Mount Sinai Medical Center, and the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai. He was awarded his MD at Boston University School of Medicine and completed an internship and residency at the Hospital of the University of Pennsylvania in Philadelphia. He received his fellowship training in Gastroenterology at the Massachusetts General Hospital. Dr. Sands also completed a Master of Science in Epidemiology at the Harvard School of Public Health. Dr. Sands was a faculty member at Harvard Medical School and Medical Co-Director of the Massachusetts General Hospital Crohn's and Colitis Center, and then served as the Acting Chief of the Gastrointestinal Unit at Massachusetts General Hospital before coming to Mount Sinai in 2010. Dr. Sands is a Fellow of the ACG and AGA. Additionally, Dr. Sands has served as the Chair of the Crohn's & Colitis Foundation of America's Clinical Research Alliance, and Chair of the Immunology, Microbiology and IBD Section of the AGA. He is an Associate Editor for the journal Gastroenterology. Dr. Sands is widely published in the area of inflammatory bowel diseases (Crohn's disease and ulcerative colitis), with numerous publications in journals such as Gastroenterology, Gut, and the New England Journal of Medicine. In addition to his extensive research background, Dr. Sands is internationally renowned for his expert care of complex inflammatory bowel disease.

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49 - Long-Term Efficacy of Ustekinumab With and Without Concomitant Immunosuppressants for Crohn’s Disease: Results From IM-UNITI Long-Term Extension Through 2 Years



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