POS1044 GUSELKUMAB PROVIDES CONSISTENT AND DURABLE PAIN IMPROVEMENT IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS OF 2 PHASE 3, RANDOMIZED, CONTROLLED CLINICAL TRIALS

Autor: P. Nash, L. S. Tam, W. C. Tsai, Y. Y. Leung, D. Furtner, S. Sheng, Y. Wang, M. Shawi, A. Kollmeier, J. Sherlock, D. Cua
Rok vydání: 2022
Předmět:
Zdroj: Annals of the Rheumatic Diseases. 81:839-840
ISSN: 1468-2060
0003-4967
Popis: BackgroundGuselkumab (GUS), an anti-IL23p19-subunit mAb, demonstrated significant efficacy vs placebo (PBO) in achieving ACR20 response at week (W) 24 in patients (pts) with active PsA in phase 3 trials, DISCOVER-1&2 (D1&2).1,2 Pts with PsA report pain relief as a treatment priority.3ObjectivesTo assess GUS treatment effect through 2 years on pt-reported pain across outcome measures.MethodsPts with active PsA in D1 (n=381; 31% received 1-2 prior TNFi) and D2 (n=739; biologic-naïve) were randomized (1:1:1) to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or PBO with crossover to GUS 100 mg Q4W at W24 (PBO→Q4W). Pts rated pain using visual analog scale (VAS; 0-10; Pt Pain) and reported Bodily Pain intensity over past 4 W via 36-Item Short-Form Health Survey question 21 (0-5). Pts with spondylitis and peripheral arthritis at baseline (BL) rated Spinal and Joint Pain (0-10). Observed mean change, % improvement from BL in tender (TJC; 0-68) and swollen joint counts (SJC; 0-66), and proportion of pts achieving ≥20/≥50% improvement in Pt Pain (nonresponder imputation [NRI]) were evaluated.ResultsIn D2, mean BL for Bodily Pain (range: 4.4-4.5), Pt Pain (6.2-6.3), Spinal Pain (6.5-6.7), Joint Pain (6.3-6.8), SJC (11.7-12.9) and TJC (19.8-22.4) indicated moderate pain and disease activity at study outset. GUS-treated pts reported ~2x improvement in Pt Pain, Spinal Pain, Joint Pain, and Bodily Pain intensity at W24 vs PBO, which were maintained or increased at W52 and W100. PBO→Q4W pts had similar improvements. Pt-reported pain appeared more sensitive to treatment effect, with larger differences in % improvement vs PBO than physician-reported TJC/SJC at W24. D1 showed consistent results through 1 year. In 748 GUS-treated pts across D1&2, substantial proportions achieved meaningful improvement in Pt Pain at early time points: 32% (W4) and 48% (W8) achieved ≥20% improvement; 28% (W12) and 33% (W16) achieved ≥50% improvement. At W24, 63%/39% reported ≥20%/≥50% improvement in pain.ConclusionGUS provided consistent and durable improvements in pt-reported pain across several outcome measures. Pt-reported pain as an early and sensitive indicator of treatment effect in pts with active PsA and additional factors merits further evaluation.References[1]Deodhar A et al. Lancet. 2020;395:1115-25[2]Mease P et al. Lancet. 2020;395:1126-36[3]Gudu T et al. Expert Rev Clin Immunol. 2018;14:405-17Table 1.Observed Mean (SD) Change from Baseline in Pain Scores, TJC, and SJC at W24, W52, and W100 in DISCOVER-2W24W52W100GUS Q4WGUS Q8WPBOGUS Q4WGUS Q8WPBO→Q4WGUS Q4WGUS Q8WPBO→Q4WPt Pain (0-10),* N240243243229234231220224215-2.39 (2.35)-2.53 (2.47)-1.08 (2.42)-2.89 (2.68)-3.20 (2.56)-2.75 (2.66)-3.52 (2.62)-3.69 (2.63)-3.41 (2.58)Spinal Pain (0-10), +N806592796488766182-2.26 (2.57)-2.54 (2.70)-1.13 (2.48)-2.74 (2.63)-2.67 (2.71)-2.65 (2.69)-3.11 (2.67)-3.44 (2.71)-3.37 (2.66)Joint Pain (0-10),+N806592796488766182-2.88 (2.17)-2.90 (2.68)-1.40 (2.91)-3.32 (2.27)-3.21 (2.76)-3.42 (2.92)-3.54 (2.35)-3.61 (2.77)-3.80 (2.95)SF-36 (Q21; 0-5), N240243242229234230220224214-0.99 (1.03)-1.03 (1.12)-0.50 (1.11)-1.18 (1.33)-1.29 (1.17)-1.10 (1.16)-1.39 (1.25)-1.47 (1.38)-1.36 (1.27)TJC (0-68), N240243243228234231220224213-11.85(9.88)-10.37(9.49)-7.26(11.15)-15.04(10.51)-13.44(10.03)-14.15(11.39)-16.37(10.70)-15.27(11.10)-16.29(11.27)SJC (0-66), N240243243228234231220224213-8.77(5.46)-8.14(6.07)-6.44(7.20)-10.38(6.17)-9.56(6.28)-10.17(6.79)-10.83(6.66)-10.20(6.88)-10.58(6.15)*ACR, DAPSA, MDA: VAS 0-10; +BASDAI: VAS 0-10ACR=American College of Rheumatology; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; DAPSA=Disease Activity in Psoriatic Arthritis; GUS=guselkumab; MDA=minimal disease activity; PBO=placebo; pt=patient; Q=question; QxW=every x week; SD=standard deviation; SF-36=36-Item Short-Form Survey; SJC=swollen joint count; TJC=tender joint count; VAS=visual analog scale; W=weekDisclosure of InterestsPeter Nash Consultant of: AbbVie, Bristol Myers Squibb, Boehringer, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Roche, Sandoz, and Sun Pharma, Grant/research support from: AbbVie, Bristol Myers Squibb, Boehringer, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Roche, Sandoz, and Sun Pharma, Lai-Shan Tam Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Pfizer, and Sanofi, Grant/research support from: Amgen, Boehringer Ingelheim, GSK, Janssen, Novartis, and Pfizer, Wen-Chan Tsai Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, and Janssen, Ying Ying Leung Consultant of: AbbVie, Eli Lilly, Janssen, and Novartis and on advisory board for Janssen, Daniel Furtner Shareholder of: Johnson & Johnson, Employee of: Janssen, a division of Johnson & Johnson Pte. Ltd, Shihong Sheng Shareholder of: Johnson & Johnson, Employee of: Janssen Research and Development, LLC, Yanli Wang Consultant of: Janssen, Employee of: Cytel, Inc., May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research and Development, LLC, Jonathan Sherlock Shareholder of: Johnson & Johnson, Employee of: Janssen Research and Development, LLC, Daniel Cua Shareholder of: Johnson & Johnson, Employee of: Janssen Research and Development, LLC
Databáze: OpenAIRE
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