AB1104 STRINGENT DISEASE ACTIVITY CONTROL AT 2 YEARS ACROSS PSORIATIC ARTHRITIS DOMAINS IRRESPECTIVE OF BASELINE CHARACTERISTICS IN PATIENTS TREATED WITH GUSELKUMAB: POST-HOC ANALYSIS OF A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Background Guselkumab (GUS) is associated with robust and sustained improvement in psoriatic arthritis (PsA) signs and symptoms in subgroups of patients (pts) pooled from the phase 3 DISCOVER-1 and DISCOVER-2 trials, across a variety of baseline (BL) pt characteristics through 1[1], and 2 years (DISCOVER-2 only)[2]. Objectives This post-hoc analysis using DISCOVER-2 data aimed to evaluate the efficacy of GUS in inducing long-term (Week [W]100) stringent disease control in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recommended domains across BL characteristics. Methods DISCOVER-2 enrolled biologic-naïve adults with active PsA defined as ≥5 swollen and ≥5 tender joint counts (SJC; TJC) and C-reactive protein (CRP) ≥0.6 mg/dL. 739 pts were randomized (1:1:1) and treated with GUS 100 mg every 4 weeks (Q4W; n=245); GUS 100 mg at Week 0, Week 4, then every 8 weeks (Q8W; n=248); or placebo (n=246) with crossover to GUS 100 mg Q4W at W24. In this analysis, only GUS-randomized pts were included (n=493). Achievement of the following outcomes at W100 was assessed: minimal disease activity (MDA), American College of Rheumatology 50% improvement (ACR50), ACR70, Investigator’s Global Assessment score of 0 (clear skin) (IGA 0), Psoriatic Arthritis Disease Activity Score – low disease activity (PASDAS LDA), resolution of enthesitis and dactylitis, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) response (≥4-point improvement), and Health Assessment Quality Disease Index (HAQ-DI) response (≥0.35-point improvement). BL characteristics of interest were pt sex, baseline body mass index (BMI), SJC, TJC, PsA duration, CRP, % body surface area (BSA) with psoriasis, and PASI score, and use of conventional synthetic (cs) DMARDs and methotrexate (MTX). Non-responder imputation was used for missing categorical response data. Results 442 (90%) GUS-randomized pts completed study treatment through W100. With few exceptions, achievement of MDA response (Figure 1) at Week 100 was demonstrated across a variety of baseline pt characteristics, without consistent differences in proportion of responders across pt subgroups of adequate sample size or between GUS dosing regimens. Similar trends were observed for achievement of ACR50, ACR70, IGA 0, PASDAS LDA, enthesitis resolution, dactylitis resolution, FACIT-F response, and HAQ-DI response. Conclusion Irrespective of dosing regimen, treatment with GUS resulted in sustained achievement of several stringent endpoints spanning key GRAPPA-recommended domains through 2 years across a variety of BL demographic and disease characteristics. These results further support the long-term efficacy of GUS across the full spectrum of PsA disease domains and diverse PsA populations. References [1]Ritchlin CT. et al. RMD Open. 2022 Mar;8(1):e002195; [2]Ritchlin CT. et al. Abstract N°AB0526. EULAR 2021. Acknowledgements: NIL. Disclosure of Interests Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, and UCB, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Wolf-Henning Boehncke Consultant of: AbbVie, Almirall, Eli Lilly, Janssen, Leo, Novartis, and UCB, John Tesser Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen and Pfizer, Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, and Pfizer, advisory board fees from Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, and Pfizer, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Eli Lilly, Gilead, Janssen, Pfizer, and Sun Pharma, Soumya D Chakravarty Employee of: Janssen Scientific Affairs, LLC; shareholder in Johnson & Johnson, of which Janssen Scientific Affairs, LLC is a wholly-owned subsidiary, Emmanouil Rampakakis Consultant of: Janssen, Employee of: JSS Medical Research, May Shawi Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson; shareholder of Johnson & Johnson, Elena Schiopu Consultant of: Janssen, Grant/research support from: Janssen, Joseph F. Merola Consultant of: AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Iain McInnes Shareholder of: Causeway Therapeutics, and Evelo Compugen; Non Exec Roles: NHS GGC Board Member, Evelo Board of Directors and Versus Arthritis Trustee Status, Consultant of: AbbVie, Amgen, Astra Zeneca, Bristol Myers Squibb, Cabaletta, Compugen, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: Astra Zeneca, Amgen, Bristol Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB, Atul Deodhar Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB.

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