AB0528 COMPARABLE SAFETY PROFILE OF GUSELKUMAB IN PSORIATIC ARTHRITIS AND PSORIASIS: RESULTS FROM PHASE 3 TRIALS THROUGH 1 YEAR

Background: DISCOVER 1&2 (PsA) and VOYAGE (PsO) are Phase 3 trials of guselkumab (GUS). Objectives: Compare safety results through up to 1yr GUS in PsA PsO pts. Methods: In DISCOVER, 1120 pts with active despite standard therapy were treated. Most biologic-naïve; ~30% 1 had previous exposure 1-2 TNFi. Concomitant MTX (57%), oral corticosteroids (17%), NSAIDs (64%) permitted. Pts randomized SC 100mg at W0, W4, then Q8W; Q4W; or PBO. At W24, PBO patients switched Q4W. VOYAGE, which concomitant use was prohibited, 1245 moderate severe treated 100 mg W12, crossover W16, W20, Q8W. AEs laboratory parameters, analyzed by National Cancer Institute-Common Terminology Criteria for [NCI-CTCAE] toxicity grades, summarized the PBO-controlled periods 1yr. Results: Safety profiles generally consistent across clinical programs (Table 1). Time-adjusted incidence rates numbers AEs, serious infections, malignancy, MACE leading d/c similar between PsA. No cases anaphylaxis opportunistic infections reported. Proportions decreased neutrophil counts elevations hepatic transaminases slightly higher vs PsO. These abnormalities mostly NCI-CTCAE Grade 2 (<LLN-1000/mm neutrophils; <5.0 x ULN AST/ ALT), transient, required no medical interventions, resolved spontaneously, did not lead interruption treatment. Through 1yr, proportions ALT/AST Q4W than Q8W without baseline use. Conclusion: The profile GUS-treated trials. Table 1. Treatment-Emergent During Period 1Yr: & Trials Pooled Time W0-16 1Yr W0-24 b (N=) (422) (823) Combined a (1221) c (372) (375) (373) GUS† (1100) Total pt-yrs follow-up 128 255 974 173 172 384 385 973 Incidence/100 (95% CI) d 317 (287,349) 330 (308,353) 259 (249, 270) 219 (198,243) 256 (232,281) 221 (200, 245) 218 (203,233) 177 (164,191) 191 (182, 199) SAEs 5 (2, 10) 6 (4, (5, 8) 9 15) 4 9) 7) study agent (0.9, 4) (1, 7 12) 6) 5) Infections 86 (71, 104) 98 (86, 111) (92, 58 (48, 71) (47, 63 (51, 76) (50, 66) 53 (46, 61) 55 60) Serious 0. 8 (0, 0.4 2) (0.5, 0.6 3) (0.4, (0.6, All Malignancy 0 0.5 1) 0.8) 0.3 1.4) 0.1 0.6) % ?1 injection site rxn 3.1 4.5 5.0 1.3 1.1 1.6 2.4 1.7 Placebo included combined column after For all who treatment early last dose PBO/GUS prior W24 receive any Wk24, data including final visit collected group due cross-over inadvertently, only first administration included. CI based on an exact method assuming observed number events follows Poisson distribution Disclosure Interests: Alice B Gottlieb Consultant of: Anaptyps Bio, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers-Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, Sun Pharmaceuticals, UCB, Xbiotech, Grant/research support from: Joseph F. Merola AbbVie, Arena, Biogen, BMS, Dermavant, Pfizer, April Armstrong Leo, Ortho Dermatologics, Dermira, KHK, Sanofi, Regeneron, Modernizing Medicine, Richard Langley Speakers bureau: Amgen, Celgene, Merck, Pizer, Pharmaceutical, UCB Mark Lebwohl Aditum Allergan, Almirall, Arcutis, Inc., BirchBioMed BMD skincare, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Evommune, Facilitate International Dermatologic Education, Foundation Research Education Dermatology, Inozyme Kyowa Kirin, Meiji Seika Menlo, Mitsubishi, Neuroderm, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, Verrica., Abbvie, Incyte, Leo Pharmaceutucals, Christopher E.M. Griffiths Ingelheim Pharma., May Shawi Shareholder Johnson Johnson, Employee Janssen Global Services, LLC, Ya-Wen Yang Elizabeth C Hsia Development, Alexa Kollmeier Xie L Xu Miwa Izutsu Paraneedharan Ramachandran Shihong Sheng Yin You Megan Miller T. Ritchlin Gilead, Iain McInnes Lilly Company, Proton Rahman Bristol Myers Roche, Novartis.