BASELINE CHARACTERISTICS OF REAL-WORLD PSORIATIC ARTHRITIS PATIENTS TREATED WITH GUSELKUMAB OR IL-17 INHIBITORS: RESULTS FROM THE ONGOING MULTINATIONAL PSABIOND STUDY

Background: Participants of randomized clinical trials may not reflect the full range of patients (pts) seen in routine clinical practice. Observational studies provide important information on a broader population of pts receiving an approved therapeutic as standard clinical care and can assess their real-world performance in the intended pt populations. In psoriatic arthritis (PsA), more recent treatment options include IL-17 inhibitors (IL-17i) and the interleukin-23 inhibitor (IL-23p19i) guselkumab (GUS). We currently have little data on who receives such treatments in a real-world setting. Objectives: To obtain an overview of the baseline (BL) profile of PsA pts initiating treatment with either GUS or an IL-17i in a real-world setting via an interim analysis of participants enrolled into an ongoing observational study (PsABIOnd). Methods: PsABIOnd (ClinicalTrials.gov ID: NCT05049798) is an ongoing, international (20 countries), prospective, observational, cohort study undertaken to assess the long-term persistence, effectiveness, and safety of treatment in adults with PsA initiating GUS or a marketed IL-17i (index agent) as a first-, second-, third-, or fourth-line biologic therapy per standard clinical practice. From August 2021 to May 2023, 586 of the planned 1,300 pts were enrolled, 483 of whom had available and analysable BL data. This interim analysis describes the socio-demographic characteristics, prior and concomitant PsA treatments, comorbidities, and BL disease parameters, including patient-reported outcomes (PROs), across the treatment cohorts. Results: Among 483 pts, 263 initiated GUS and 220 initiated an IL-17i (132 secukinumab, 88 ixekizumab). At BL, the GUS/IL-17i cohorts were generally well balanced for mean (SD) age (51.3 [12.8]/53.4 [12.0] y), PsA duration (7.6 [7.6]/7.2 [8.5] y), and sex (37%/40% male), with no significant differences observed between cohorts. Pt socio-demographic/disease characteristics and concomitant PsA treatments were also comparable between treatment cohorts ( Tables 1&2 ). Both GUS and IL-17i were predominantly prescribed as 1 (33%/36%, respectively) or 2 (27%/34%) line biologic treatment, while GUS was more commonly prescribed as a 4 -line biologic vs. IL-17i (19%/10%). Among biologic-experienced pts, more pts in the GUS than IL-17i cohort initiated the index agent due to primary failure of the previous biologic agent (30%/22%). Comorbidities were commonly reported across the GUS/IL-17i cohorts, the most common being cardiometabolic disease (48%/44%) and obesity (44%/34%). Approximately one-third of pts had a FiRST score suggesting fibromyalgia (39%/34%). Mean cDAPSA/DAPSA levels (26.4-28.8) indicated moderate-to-high joint disease activity across cohorts. Tender (4.3/4.6) and swollen (10.1/11.4) joint counts; proportions of pts with enthesitis (52%/56%), dactylitis (18%/20%), nail disease (44%/47%), and axial involvement (33%/34%); and PROs, e.g., pt pain, HAQ-DI, WPAI, also generally consistent across treatment cohorts, suggested multi-domain disease with substantial impact on physical function and productivity. However, a higher proportion of pts in the GUS cohort had severe psoriasis (14%/7% with BSA>10%) and mean Dermatology Life Quality Index (DLQI) was worse compared with the IL-17i cohort (7.9/5.5) ( Table 2 ). Conclusion: In this interim analysis of PsA pts enrolled in the multinational PsABIOnd study, GUS and IL-17i were used as 1 - or 2 -line biologic treatment in 60-70% of these real-world setting pts. On average, pts across treatments were characterized by moderate-to-severe joint disease activity, multi-domain disease, and impaired activity and work productivity. Compared with pts treated with IL-17i, GUS was more often given in pts with more severe skin disease and obesity. These findings show a cross-sectional snapshot of prescription patterns and can be helpful to interpret forthcoming real-world effectiveness data. REFERENCES: [1] Siebert S. Rheumatol Ther 2023;10:489. Acknowledgements: NIL. Disclosure of Interests: Laure Gossec consulting fees from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, research grants from Amgen, Eli Lilly, Galapagos, Pfizer, Sandoz, Xenofon Baraliakos consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, Ennio Lubrano speaker fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Rubén Queiro speaker and/or consultancy fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer, speaker and/or consultancy fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer, restricted research grants from AbbVie, Janssen, and Novartis, Frank Behrens speaker and/or consultancy fees from AbbVie, Amgen, Affibody, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Chugai, Lilly, Galapagos, GSK, Janssen, MoonLake, Novartis, Pfizer, Sanofi Genzyme, Sandoz, UCB Pharma, speaker and/or consultancy fees from AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Chugai, Eli Lilly, Galapagos, GSK, Janssen, MoonLake, Novartis, Pfizer, Sanofi Genzyme, Sandoz, UCB Pharma, research grants from AbbVie, Bionorica, Chugai, GSK, Janssen, Roche, Mohamed Sharaf shareholder of Johnson & Johnson, employee of EMEA Medical Affairs Janssen MEA, Dubai United Arab Emirates, Emmanouil Rampakakis employee of JSS Medical Research, paid consultant of Janssen, László Köleséri employee of IQVIA Data Science Staffing Solutions Statistical Services, paid consultant of Janssen, Frédéric Lavie owns stock or stock options in Johnson & Johnson, employee of Janssen Medical Affairs, LLC, Stefan Siebert speaker and/or consultancy fees from AbbVie, Biogen, Celgene, Eli Lilly, GSK, Janssen, Novartis and UCB, speaker and/or consultancy fees from AbbVie, Biogen, Celgene, Eli Lilly, GSK, Janssen, Novartis and UCB, institutional research funding from Amgen (previously Celgene), Boehringer-Ingelheim, Bristol-Myers-Squibb, Eli Lilly, Janssen and UCB. DOI: 10.1136/annrheumdis-2024-eular.1860 Keywords: Observational studies/ registry, Real-world evidence, Biological DMARD Citation: , volume 83, supplement 1, year 2024, page 1476Session: Psoriatic arthritis (Publication Only)

Observational studies/ registry, Real-world evidence, Biological DMARD