AB1093 LONG-TERM IMPROVEMENT IN INDIVIDUAL ACR RESPONSE CRITERIA AND RESIDUAL DISEASE IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH GUSELKUMAB: POST HOC ANALYSIS OF A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Background Treatment effects on PsA joint symptoms are assessed by ACR response rates, reflecting percentages of patients (pts) meeting a composite measure of improvement from baseline (BL) at specific timepoints. Alternatively, the ACR-numeric (ACR-N) is a continuous measure of improvement based on 7 ACR components. Objectives Contrast performance of ACR response rates with ACR-N in characterizing guselkumab (GUS) treatment effect in PsA and describe duration and extent of continuous improvement with GUS using ACR-N and ACR components through week (W) 100. Methods The phase 3 DISCOVER-2 trial enrolled bio-naïve adults with active PsA (swollen and tender joint counts [SJC/TJC] ≥5, C-reactive protein [CRP] ≥0.6 mg/dL). 739 pts were randomized (1:1:1) and treated with GUS 100 mg every 4W (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO) with crossover to GUS Q4W at W24. ACR20/50/70 response rates through W100 were determined using non-responder imputation (NRI) for missing data; GUS Q4W/Q8W and PBO rates were compared through W24. Duration of continuous improvement over 100W of GUS was assessed by contrasting least square mean (LSM) ACR-N and ACR component values between consecutive visits. Percent changes in SJC, TJC, physician global (MDGA), pt global (PtGA), health assessment quality disease index (HAQ-DI), CRP, and pt-pain were also assessed, adjusting for treatment group, BL use of csDMARDs, and respective BL scores. Results ACR response rates were significantly greater with GUS Q4W/Q8W vs PBO by W4 (ACR20), W8 (ACR50), and W8-12 (ACR70); significant differences in ACR-N between GUS Q4W/Q8W vs PBO were observed by W2 (GUS Q4W) or W8 (GUS Q8W) (Table 1; nominal p<0.05). Similar responses were observed with GUS Q4W and Q8W. Among GUS-treated pts, nominally significant improvements comparing ACR-N scores across consecutive visits were observed by W2, with a positive trajectory through W100 (Figure 1). Individual ACR components also significantly improved by W2 and – apart from CRP levels that rapidly plateaued to means <1 mg/dL – continued to improve vs previous visit through W68-84 of GUS (nominal p<0.05). Conclusion GUS rapidly improved PsA activity whether assessed by ACR response or ACR-N. Early response was apparent across ACR components, followed by a positive trajectory through 2 years of GUS that yielded low levels of residual disease. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Peter Nash Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Samsung, Sun Pharma, and UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Samsung, Sun Pharma, and UCB, Iain McInnes Shareholder of: Causeway Therapeutics and Evelo Compugen, 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, May Shawi Shareholder of: Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Francois Nantel Shareholder of: Johnson & Johnson, Consultant of: Janssen, Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Emmanouil Rampakakis Consultant of: Janssen, Employee of: JSS Medical Research, Inc., Enrique Soriano Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Janssen, Novartis, and Roche, Grant/research support from: AbbVie, Janssen, Novartis, Pfizer, Roche, and UCB, Dafna D Gladman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Eli Lilly, Janssen, Pfizer, 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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