POS1538 SAFETY OF GUSELKUMAB ACROSS DIVERSE PATIENT SUBGROUPS WITH PSORIATIC DISEASE: AN INTEGRATED ANALYSIS OF 11 PHASE 2/3 CLINICAL STUDIES IN PSORIASIS AND PSORIATIC ARTHRITIS

Background A higher prevalence of comorbidities, such as obesity, prior treatments, and certain demographics (e.g., age and sex) in patients (pts) with psoriatic disease (PsD) may lead to an increased risk of adverse events (AEs), sometimes serious [1]. Guselkumab (GUS), a fully human, selective IL-23p19-subunit inhibitor approved to treat (tx) adults with active psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO), has shown a favorable safety profile consistent between PsA and PsO pts through up to 2 and 5 years (yrs) of follow-up in the pooled PsA and PsO trials, respectively [2]. Objectives An integrated post hoc analysis evaluated GUS safety in subgroups of pts with PsD, stratified by baseline (BL) characteristics of interest, using pooled safety data from 11 Phase 2/3 trials of GUS, including four in PsA (Phase 2, DISCOVER-1, DISCOVER-2, COSMOS) and seven in PsO (X-PLORE, VOYAGE-1, VOYAGE-2, NAVIGATE, ORION, ECLIPSE, Japanese registration). Methods GUS 100 mg subcutaneous (SC) was administered at Week (W) 0, W4, then every 4 W (Q4W) or Q8W in PsA trials and at W0, W4, then Q8W in PsO trials (additional doses were investigated in X-PLORE). Pts randomized to placebo (PBO) crossed over to GUS Q4W or Q8W at W24 in PsA trials and to GUS Q8W at W16 in 5 of the PsO trials. Pooled safety data were summarized for the PBO-controlled period (PsA: W0-24; PsO: W0-16) and through the end of the reporting period (PsA: up to 2 yrs; PsO: up to 5 yrs). Incidence rates of key safety events were adjusted for duration of follow-up and reported per 100 pt-yrs (PY), along with 95% CI. BL characteristics of interest in pts randomized to GUS or PBO (N=3318), were prior biologic use (26% yes; 74% no), age (94% <65; 6% ≥65 yrs), sex (62% male; 38% female), and BMI (26% under/normal weight; 34% overweight; 40% obese). Results During the PBO-controlled periods, 1061 pts received PBO (395 PY) and 2257 received GUS (856 PY). Through the end of the reporting periods, 4399 GUS-tx pts (PsA: 1508; PsO: 2891) contributed 10,787 PY of follow-up (PsA: 2125 PY; PsO: 8662 PY). BL characteristics were similar across 4 PsA trials and generally similar across 7 PsO trials. The PsO trials included more males and pts with extensive skin disease than the PsA trials. Distribution of PsD pts across BL subgroups generally provided sufficient sample size, although pts ≥65 yrs accounted for only 6% of all PsD pts. Throughout the PBO-controlled period, pooled incidence rates of overall AEs were generally similar between GUS- and PBO-tx pts and rates of serious AEs (SAEs), AEs leading to study agent discontinuation, infections, and serious infections were low and comparable between GUS- and PBO-tx pts, regardless of the BL characteristics assessed. The rates of safety events evaluated were stable or reduced through the end of the reporting period for GUS-tx pts within each BL subgroup (Figure 1). Conclusion This comprehensive integrated analysis of GUS safety demonstrated a favorable safety profile across a broad population of pts irrespective of the BL characteristics assessed. Overall, safety event rates in GUS-tx pts were comparable to or lower than PBO during short-term follow-up. Rates of SAEs and serious infections remained low and stable through long-term follow-up. References [1]Strober B, et al. J Am Acad Dermatol. 2018;78:323-332. [2]Strober B, et al. Poster presented at: Innovations in Dermatology; April 27-30, 2022; Scottsdale, AZ. Acknowledgements: NIL. Disclosure of Interests Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Bruce Strober Speakers bureau: AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Connect Biopharma, CorEvitas Psoriasis Registry, Dermavant, Dermira, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics, Incyte, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics, Paid instructor for: AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Connect Biopharma, CorEvitas Psoriasis Registry, Dermavant, Dermira, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics, Incyte, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics; served as Co-Scientific Director (consulting fee) of CorEvitas Psoriasis Registry and Editor-in-Chief (honorarium) of Journal of Psoriasis and Psoriatic Arthritis., Consultant of: AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Connect Biopharma, CorEvitas Psoriasis Registry, Dermavant, Dermira, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics, Incyte, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics, Jenny Yu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Evan Leibowitz Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Katelyn Rowland Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Megan Miller Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Yanli Wang Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Shu Li Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Daphne Chan Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, May Shawi Shareholder of: Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Ya-Wen Yang Shareholder of: Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Mark Lebwohl Consultant of: Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Arcutis, Inc., Arena Pharmaceuticals, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, CorEvitas, Dermavant Sciences, Dr. Reddy’s Laboratories, Evelo Biosciences, Evommune, Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd., LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica., Grant/research support from: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc., Employee of: Icahn School of Medicine at Mount Sinai, New York, Proton Rahman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Grant/research support from: Janssen and Novartis.

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