ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1342

Low Incidence of Gastrointestinal-related and Overall Serious Adverse Events Among Guselkumab-treated Patients: Pooled Analyses of VOYAGE 1 & 2 and DISCOVER 1 & 2 Through 1-Year

Philip Mease1, Peter Foley2, Kristian Reich3, Jerry Bagel4, Mark Lebwohl5, Ya-Wen Yang6, May Shawi7, Megan Miller8, Alexa Kollmeier9, Elizabeth Hsia8, Xie Xu8, Miwa Izutsu10, Paraneedharan Ramachandran10, Shihong Sheng8, Yin You8, Philip S Helliwell11 and Wolf-Henning Boehncke12, 1Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 2University of Melbourne, Carlton, Australia, 3University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 4Psoriasis Treatment Center of Central New Jersey, Department of Dermatology, East Windsor, NJ, USA, East Windsor, NJ, 5Icahn School of Medicine at Mount Sinai, New York, NY, 6Janssen Global Services, LLC, Horsham, PA, 7Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, 8Janssen Research & Development, LLC, Spring House, PA, 9Janssen Research & Development, LLC, La Jolla, CA, 10Janssen Research & Development, LLC, Immunology, Spring House, PA, 11Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 12Geneva University Hospitals, Geneva, Switzerland

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Monday, November 8, 2021

Title: Spondyloarthritis Including PsA – Treatment Poster II: Psoriatic Arthritis I (1329–1363)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Guselkumab (GUS), an anti-interleukin (IL)-23p19-subunit mAb, demonstrated efficacy in VOYAGE (VOY) 1&2 patients (pts) with moderate to severe plaque psoriasis (PsO)1,2 and in DISCOVER (DISC) 1&2 pts with active PsA.3,4 IL-17 inhibitors used to treat PsO and PsA have been associated with exacerbation or new onset of IBD.5 We evaluated the incidence of gastrointestinal (GI)-related and overall serious adverse events (SAEs) from pooled safety data through 1-year of GUS 100 mg treatment from the phase 3 VOY 1&2 and DISC 1&2 trials.

Methods: Using pooled safety data from VOY 1&2 PsO and DISC 1&2 PsA trials, GI-related SAEs were identified using the Medical Dictionary for Regulatory Activities (MedDRA) system-organ class “GI disorders”. Pts with a previous history of IBD were not excluded; IBD history was collected at baseline in DISC 1&2. Rates of overall and GI-related SAEs were calculated as the number of SAEs per 100 pt-years (PY) of follow-up (95% confidence intervals). Data are presented for the placebo (PBO)-controlled period (VOY 1&2: Weeks [W] 0-16; DISC 1&2: W0-24) and through 1-year (VOY 1&2: through W48; DISC 1: through W60, DISC 2: through W52). Events of uveitis and opportunistic infections were also analyzed.

Results: Through the PBO-controlled period, the overall rates of GI-related SAEs per 100 PY for pooled VOY 1&2 were: PBO 0.78 (0.02, 4.34), GUS every (q) 8w 0; and for pooled DISC 1&2: PBO 0.58 (0.01, 3.23), GUS q8w 0.58 (0.01, 3.21), GUS q4w 0. The GI-related SAEs included: VOY 1&2, gastrointestinal hemorrhage (PBO; n=1); and DISC 1&2, IBD (PBO; n=1) and mechanical ileus (GUS q8w; n=1). Through 1-year, overall rates of GI-related SAEs for VOY 1&2 were: combined GUS group (GUS q8w + PBO→GUS) 0.51 (0.17, 1.20); and for DISC 1&2: GUS q8w 0.52 (0.06, 1.88), GUS q4w 0, combined GUS group (GUS q8w + GUS q4w + PBO→GUS) 0.21 (0.02, 0.74). The GI-related SAEs in the combined GUS group for pooled VOY 1&2 included: gastritis, hemorrhoids, inguinal hernia, pancreatitis, and umbilical hernia (0.10/100 PY [0.00, 0.57]; n=1 for each); and in the combined GUS group for pooled DISC 1&2: mechanical ileus and pancreatitis chronic (0.10/100 PY [0.00, 0.57]; n=1 for each). Overall, no cases of exacerbation or new onset of IBD were reported in GUS-treated pts, including 2 pts with a prior history of IBD in DISC 1&2 (total PY of follow-up for the combined GUS groups in VOY and DISC were 974 and 973, respectively). Through the PBO-controlled period, rates of overall SAEs for GUS-treated pts were comparable to PBO-pts and SAE rates remained low through 1-year of follow-up in VOY 1&2 and DISC 1&2. No cases of uveitis, opportunistic infections, or tuberculosis were reported in GUS-treated pts through 1-year.

Conclusion: Through 1-year of follow-up with GUS treatment in pooled VOY 1&2 and DISC 1&2, GI-related SAE rates were low. There were no reported cases of uveitis, opportunistic infections, or new onset/exacerbation of IBD in GUS-treated pts. No new safety concerns were identified through 1-year.

1. Blauvelt A., et al. J Am Acad Dermatol. 2017;76:405-17

2. Reich K., et al. J Am Acad Dermatol. 2017;76:418-31

3. Deodhar A., et al. Lancet. 2020;395:1115-25

4. Mease P.J., et al. Lancet. 2020;395:1126-36

5. Hohenberger M., et al. J Dermatolog Treat. 2018;29:13-8

Disclosures: P. Mease, AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, 5, Celgene, 2, Boehringer Ingelheim, 2, Genentech, 2, 5, 6, Janssen, 2, 5, 6, Gilead Sciences, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 6, GSK, 2; P. Foley, AbbVie, 1, 5, 6, 12, Travel grants, Amgen, 1, 5, Celgene, 1, 5, 6, Aslan, 1, 5, Janssen, 1, 2, 5, 6, 12, Travel grants, Leo Pharma, 1, 2, 5, 6, 12, Travel grants, Eli Lilly, 1, 2, 5, 6, 12, Travel grants, Merck, 1, 2, 5, 6, 12, Travel grants, Novartis, 1, 2, 5, 6, 12, Travel grants, Pfizer, 1, 2, 5, 6, 12, Travel grants, Sanofi, 2, 5, 12, Travel grants, Sun Pharma, 1, 2, 5, 12, Travel grants, AstraZeneca, 5, Arcutis, 5, Boehringer Ingelheim, 2, Hexima, 5, UCB Pharma, 2, 5, Valeant, 5, 6, Bristol Myers Squibb, 1, 2, 5, Celtaxsys, 5, CSL, 5, Cutanea, 5, Dermira, 5, Galderma, 1, 5, 6, Genentech, 5, GlaxoSmithKline, 1, 5, 6, Regeneron, 5, Reistone, 5, Roche, 2, 5, 6, 12, Travel grants; K. Reich, AbbVie, 1, 5, 6, Amgen, 1, Janssen, 1, 5, 6, Novartis, 1, 5, 6, Pfizer, 1, 5, UCB Pharma, 1, 5, Affibody, 1, 5, Almirall, 1, 5, 6, Boehringer Ingelheim, 1, 5, Bristol Myers Squibb, 1, 5, 6, Celgene, 1, 5, 6, Forward Pharma, 1, 5, Galderma, 1, 5, Kyowa Kirin, 1, 5, Leo Pharma, 1, 5, 6, Eli Lilly, 1, 5, 6, Medac, 1, 5, 6, Ocean Pharma, 1, 5, Sanofi, 1, 5, 6, MoonLake Immunotherapeutics, 3; J. Bagel, AbbVie, 2, 5, 6, Amgen, 2, 5, Arcutis Biotherapeutics, 5, Boehringer Ingelheim, 5, Bristol Myers Squibb, 5, Celgene Corporation, 2, 5, 6, Corrona, LLC, 5, Dermavant Sciences, LTD, 5, Dermira/UCB, 5, Eli Lilly and Company, 2, 5, 6, Glenmark Pharmaceuticals Ltd, 5, Janssen Biotech, 2, 5, 6, Kadmon Corporation, 5, Leo Pharma, 2, 5, Lycera Corp, 5, Menlo Therapeutics, 5, Novartis, 2, 5, 6, Pfizer, 5, Regeneron Pharmaceuticals, 5, Sun Pharmaceutical Industries Ltd, 2, 5, Taro Pharmaceutical Industries Ltd, 5, Valeant Pharmaceuticals, 2, 5; M. Lebwohl, Aditum Bio, 2, Abbvie, 5, Allergan, 2, Almirall, 2, Amgen, 5, Arcutis, Inc., 2, 5, Avotres Therapeutics, 2, BirchBioMed Inc., 2, BMD skincare, 2, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb, 2, Cara Therapeutics, 2, Castle Biosciences, 2, CorEvitas, LLC, 2, Dermavant Sciences, 2, 5, Evelo, 2, Eli Lilly, 5, Evommune, 2, 5, Facilitate International Dermatologic Education, 2, Foundation for Research and Education in Dermatology, 2, Inozyme Pharma, 2, Kyowa Kirin, 2, Leo Pharmaceutucals, 2, 5, Meiji Seika Pharma, 2, Incyte, 5, Janssen, 5, Menlo, 2, Mitsubishi, 2, Neuroderm, 2, Ortho Dermatologics, 5, Pfizer, 2, 5, Promius/Dr. Reddy’s Laboratories, 2, Serono, 2, Theravance, 2, Verrica, 2, UCB, 5; Y. Yang, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; M. Shawi, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; M. Miller, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; A. Kollmeier, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; E. Hsia, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; X. Xu, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; M. Izutsu, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; P. Ramachandran, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; S. Sheng, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; Y. You, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; P. Helliwell, Pfizer Inc, 1, Novartis, 6, Janssen, 1, 6, AbbVie, 6, Galapagos, 1, Eli Lilly, 1; W. Boehncke, Leo, 2, 6, Pfizer, 5, Abbvie, 2, 6, Almirall, 2, 6, Celgene, 2, 6, Janssen, 2, 6, Eli Lilly, 2, 6, Novartis, 2, 6, UCB, 2, 6.

To cite this abstract in AMA style:

Mease P, Foley P, Reich K, Bagel J, Lebwohl M, Yang Y, Shawi M, Miller M, Kollmeier A, Hsia E, Xu X, Izutsu M, Ramachandran P, Sheng S, You Y, Helliwell P, Boehncke W. Low Incidence of Gastrointestinal-related and Overall Serious Adverse Events Among Guselkumab-treated Patients: Pooled Analyses of VOYAGE 1 & 2 and DISCOVER 1 & 2 Through 1-Year [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/low-incidence-of-gastrointestinal-related-and-overall-serious-adverse-events-among-guselkumab-treated-patients-pooled-analyses-of-voyage-1-2-and-discover-1-2-through-1-year/. Accessed .

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