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