ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2604

Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate to Severe Plaque Psoriasis: Data from 3 Large Randomized Clinical Trials

Melinda Gooderham1, Boni E. Elewski2, David M. Pariser3, Howard Sofen4, Alan M Mendelsohn5, Nicole Cichanowitz6 and Qing Li6, 1Probity Medical Research, and Skin Center for Dermatololgy, Waterloo, and Peterborough, ON, Canada, 2University of Alabama at Birmingham, Birmingham, AL, 3Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, 4Ronald Reagan UCLA Medical Center, Department of Medicine (Dermatology) UCLA, Los Angeles, CA, 5Sun Pharmaceutical Industries, Inc., Princeton, NJ, 6Merck & Co., Inc., Kenilworth, NJ

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose: Tildrakizumab (TIL), a high-affinity, humanized, immunoglobulin G1κ, anti–interleukin-23p19 monoclonal antibody, has demonstrated efficacy in the treatment of chronic plaque psoriasis.1,2 Here, we evaluate the incidence of gastrointestinal (GI) adverse events (AE), specifically cases of inflammatory bowel disease (IBD), reported during the TIL clinical development program.

Methods: Patients with moderate to severe plaque psoriasis were randomized in 3 large clinical trials: P05495 (phase 2; NCT01225731),1 reSURFACE 1 (phase 3; NCT01722331),2 and reSURFACE 2 (phase 3; NCT01729754).2 In this post hoc analysis, we identified serious GI AEs and new onset or exacerbation of preexisting IBD from a pooled dataset of patients receiving TIL in these 3 studies, which followed patients up to 52 (P05495 and reSURFACE 2) or 64 (reSURFACE 1) weeks. TIL doses were 5 mg, 25 mg, 100 mg, and 200 mg in P05495, and 100 mg and 200 mg in the reSURFACE studies.

Results: In this analysis, we pooled 1911 patients from the 3 trials who received either TIL 100 mg or 200 mg. There were no new cases of IBD reported; among 6 patients with a history of IBD randomized to TIL, none experienced an exacerbation. The number (rate per 100 patient-years) of patients in the pooled dataset who experienced serious GI AEs was 8 (0.80) for TIL 100 mg and 4 (0.43) for TIL 200 mg. These serious GI AEs included abdominal pain, constipation, diverticulum, dyspepsia, gastritis, thrombosed hemorrhoids, esophageal polyp, and pancreatitis (1 patient each) among patients receiving TIL 100 mg and abdominal hernia, upper abdominal pain, acute pancreatitis, and salivary gland enlargement (1 patient each) among patients receiving TIL 200 mg.

Conclusion: Serious GI AEs were found to be infrequent in this post hoc analysis of patients with chronic plaque psoriasis receiving TIL in 3 large randomized clinical trials. No new cases of IBD or exacerbations of preexisting IBD were observed during treatment with TIL.

References

  1. Papp K, et al. Br J Dermatol. 2015;173:930–939.
  2. Reich K, et al. Lancet. 2017;390:276–288.

Analyses were presented at the 2018 American Academy of Dermatology Annual Meeting, February 16–20, 2018, San Diego, CA, USA.

Disclosure: M. Gooderham, AbbVie, Actelion Pharmaceuticals, Akros Pharma Inc, Amgen, Arcutis Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb Co, Celgene, Dermira, Eli Lilly and Co., Galderma, GSK, Glenmark, Janssen, LEO Pharma, Medimmine, Merck & Co, Novartis, Pfizer, 5,AbbVie, Actelion Pharmaceuticals, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Co., Galderma, Janssen, LEO Pharma, Merck & Co., Novartis, Pfizer Inc., Regeneron, Sanofi Genzyme, and Valeant Pharmaceuticals Inc., 5; B. E. Elewski, AbbVie, Boehringer Ingelheim, Celgene, Incyte, Leo, Lilly, Merck, Novartis, Pfizer, Regeneron, Sun Pharmaceuticals Inc., Valeant (Ortho dermatology), 2,Boehringer Ingelheim, Celgene, Leo, Lilly, Novartis, Pfizer, Sun Pharmaceuticals Inc., Valeant (Ortho dermatology), 5; D. M. Pariser, Abbott Laboratories, Amgen, Asana Biosciences, Bickel Biotechnology, Celgene, Dermavant Sciences, Eli Lilly, LEO Pharma US, Merck & Co., Novartis, Novo Nordisk, Ortho Dermatologics, Peplin Inc., Pfizer Inc., Photocure ASA, Promius Pharmaceuticals, 2,Bickel Biotechnology, Biofrontera AG, Celgene Corporation, Dermira, DUSA Pharmaceuticals Inc., LEO Pharma US, Novartis, Promius Pharmaceuticals, Regeneron, Sanofi, TheraVida, and Valeant Pharmaceuticals, 5,Pfizer, Inc., 5; H. Sofen, Amgen, Boehringer Ingelheim, Janssen, Lilly, Merck & Co., Novartis, Pfizer, 5,Janssen, Lilly, Novartis, 5,Janssen, Lilly, Novartis, 8; A. M. Mendelsohn, Sun Pharmaceutical Industries Inc, 3; N. Cichanowitz, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, 1, 3; Q. Li, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, 3.

To cite this abstract in AMA style:

Gooderham M, Elewski BE, Pariser DM, Sofen H, Mendelsohn AM, Cichanowitz N, Li Q. Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate to Severe Plaque Psoriasis: Data from 3 Large Randomized Clinical Trials [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/incidence-of-serious-gastrointestinal-events-and-inflammatory-bowel-disease-among-tildrakizumab-treated-patients-with-moderate-to-severe-plaque-psoriasis-data-from-3-large-randomized-clinical-trials/. Accessed .

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