Comparable Safety Profile of Guselkumab in Psoriatic Arthritis and Psoriasis: Results from Phase 3 Trials Through 1 Year

Proton Rahman¹, Alice Gottlieb², Joseph Merola³, April Armstrong⁴, Richard Langley⁵, Mark Lebwohl², Christopher Griffiths⁶, May Shawi⁷, Ya-Wen Yang⁸, Elizabeth Hsia⁹, Alexa Kollmeier¹⁰, Xie Xu⁹, Miwa Izutsu¹¹, Paraneedharan Ramachandran¹¹, Shihong Sheng⁹, Yin You⁹, Megan Miller⁹, Christopher Ritchlin¹² and Iain McInnes¹³, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁴Keck School of Medicine, University of Southern California, Clinical Research, Los Angeles, CA, ⁵Dalhousie University, Division of Clinical Dermatology & Cutaneous Science, Halifax, NS, Canada, ⁶University of Manchester, Manchester Centre for Dermatology Research, Manchester, United Kingdom, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Global Services, LLC, Horsham, PA, ⁹Janssen Research & Development, LLC, Spring House, PA, ¹⁰Janssen Research & Development, LLC, La Jolla, CA, ¹¹Janssen Research & Development, LLC, Immunology, Spring House, PA, ¹²Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ¹³University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom

Meeting: ACR Convergence 2021

Keywords: Psoriatic arthritis

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: DISCOVER 1&2 (PsA) and VOYAGE 1&2 (psoriasis [PsO]) are Phase 3 trials of guselkumab (GUS). Here we compared safety results through up to 1 year of GUS in PsA and PsO patients.

Methods: In DISCOVER 1&2, 1120 patients with active PsA despite standard therapy were treated. Most patients were biologic-naïve; ~30% in DISCOVER 1 had previous exposure to 1-2 TNFi. Concomitant MTX (57%), oral corticosteroids (17%), and NSAIDs (64%) were permitted. Patients were randomized to subcutaneous (SC) GUS 100 mg at week (W) 0, W4, then every 8 weeks (Q8W); GUS 100 mg Q4W; or placebo (PBO). At W24, PBO patients were switched to GUS 100 mg Q4W. In VOYAGE 1&2, in which concomitant MTX use was prohibited, 1245 patients with moderate to severe PsO were treated and randomized to SC GUS 100 mg at W0, W4, W12, then Q8W; or PBO at W0, W4, W12, with crossover to GUS at W16, W20, then Q8W. Adverse events (AEs) and laboratory parameters, analyzed by National Cancer Institute-Common Terminology Criteria for AEs [NCI-CTCAE] toxicity grades, were summarized through the PBO-controlled periods and 1 year.

Results: Safety profiles were generally consistent across the GUS PsO and PsA clinical programs (Table). Time-adjusted incidence rates for numbers of AEs, serious AEs, serious infections, malignancy, major adverse cardiovascular events and AEs leading to discontinuation were generally similar between PsO and PsA. No cases of anaphylaxis or opportunistic infections were reported. Proportions of patients with decreased neutrophil counts and elevations in hepatic transaminases were slightly higher in PsA versus PsO. These abnormalities were mostly of NCI-CTCAE Grade 1 or 2 (< lower limit of normal-1000/mm³ for neutrophils; < 5.0 x upper limit of normal for aspartate transaminase/alanine aminotransferase [AST/ALT]), generally transient, required no medical interventions, resolved spontaneously, and did not lead to interruption or discontinuation of treatment. Through 1 year, proportions of patients with ALT/AST elevations in PsA trials were slightly higher for GUS Q4W than Q8W and in patients with versus without baseline MTX use.

Conclusion: The GUS safety profile was generally consistent in PsA and PsO GUS-treated patients through 1 year of the DISCOVER and VOYAGE trials.

Disclosures: P. Rahman, Janssen, 2, 5, 6, Novartis, 2, 5, 6, AbbVie, 2, 6, Amgen, 2, 6, Bristol Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Merck, 2, 6; A. Gottlieb, Boehringer Ingelheim, 1, 2, 5, Incyte, 1, 2, 5, Janssen, 1, 2, 5, Novartis, 1, 2, 5, UCB, 1, 2, 5, Xbiotech, 1, 2, 5, Bristol Myers Squibb, 1, 2, LEO Pharma, 1, 2, AnaptysBio, 1, 2, Avotres, 1, 2, Eli Lilly, 1, 2, Pfizer, 1, 2, Beiersdorf, 1, 2, Sun Pharmaceuticals, 1, 2, 5, Dermavant, 1, 2, GlaxoSmithKline, 1, 2; J. Merola, AbbVie, 2, Biogen, 2, Bristol Myers Squibb, 2, Dermavant, 2, Eli Lilly, 2, 5, Janssen, 2, Novartis, 2, Pfizer, 2, UCB Pharma, 2, Amgen, 2, 5, Sanofi, 2, Regeneron, 2, Leo Pharma, 2; A. Armstrong, AbbVie, 2, 12, Research Investigator, Janssen, 2, 12, Research Investigator, Lilly, 2, 12, Research investigator, Novartis, 2, 12, Research investigator, Leo, 3, 12, Research investigator, UCB, 2, 12, Research investigator, Ortho Dermatologics, 2, 12, Ortho Dermatologics, Dermira, 2, 12, Research investigator, KHK, 2, 12, Research investigator, Sanofi, 2, 12, Research investigator, Regeneron, 2, 12, Research investigator, Sun Pharma, 2, 12, Research investigator, Bristol Myers Squibb, 2, 12, Research investigator, Dermavant, 2, 12, Research investigator, Modernizing Medicine, 2, 12, Research investigator; R. Langley, AbbVie, 1, 6, Amgen, 1, 6, Boehringer Ingelheim, 1, 6, Celgene, 1, 6, Janssen, 1, 6, LEO Pharma, 1, 6, Eli Lilly, 1, 6, Merck, 1, 6, Novartis, 1, 6, Pfizer, 1, 6, Sun Pharma, 1, 6, UCB Pharma, 1, 6; 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; C. Griffiths, AbbVie, 5, 6, Amgen, 5, 6, Almirall, 5, 6, Bristol-Myers Squibb, 5, 6, Boehringer Ingelheim, 5, 6, Celgene, 5, 6, Janssen, 5, 6, LEO Pharma, 5, 6, Eli Lilly, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Sun Pharma, 5, 6, UCB Pharma, 5, 6; M. Shawi, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; Y. Yang, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; E. Hsia, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; A. Kollmeier, 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; M. Miller, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; C. Ritchlin, UCB, 2, 5, AbbVie, 2, 5, Amgen, 2, 5, Eli Lilly, 2, Pfizer, 2, Novartis, 2, Gilead, 2, Janssen, 2; I. McInnes, Bristol Myers Squibb, 2, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Novartis, 2, 5, UCB, 2, 5, Gilead, 2, AbbVie, 2, AstraZeneca, 5, Boehringer Ingelheim, 2, Amgen, 2, 5, 6, Pfizer, 2, 5, 6.

To cite this abstract in AMA style:

Rahman P, Gottlieb A, Merola J, Armstrong A, Langley R, Lebwohl M, Griffiths C, Shawi M, Yang Y, Hsia E, Kollmeier A, Xu X, Izutsu M, Ramachandran P, Sheng S, You Y, Miller M, Ritchlin C, McInnes I. Comparable Safety Profile of Guselkumab in Psoriatic Arthritis and Psoriasis: Results from Phase 3 Trials Through 1 Year [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/comparable-safety-profile-of-guselkumab-in-psoriatic-arthritis-and-psoriasis-results-from-phase-3-trials-through-1-year/. Accessed .

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