Background: In clinical practice, patients often present with limited joint involvement or oligoarthritis, while those in clinical trials typically have polyarticular disease. Oligoarticular PsA may account for up to 60% of PsA cases [1]. Among patients with PsA naïve to biologics, nearly 75% had oligoarthritis or no joint involvement at treatment initiation [2]. Risankizumab (RZB), a monoclonal antibody that specifically inhibits interleukin-23, has shown efficacy and safety in treating biologic-naïve PsA in two phase 3 trials [3, 4]. However, there is limited real-world evidence on RZB’s effectiveness for biologic-naïve PsA patients with limited joint involvement, particularly oligoarthritis.

Objectives: This study aims to evaluate the real-world effectiveness and satisfaction of patients and physicians with RZB treatment among biologic-naïve PsA patients with limited joint involvement or oligoarthritis in the United States (US) and Europe.

Methods: This retrospective analysis was conducted from June 2023 to June 2024 using data from the Adelphi Spondyloarthritis VI Disease Specific Programme™, focusing on biologic-naïve patients with PsA who received RZB 150 mg (subcutaneous injection) and had limited joint involvement (≥ 1 to ≤ 8 tender joint count [TJC] or swollen joint count [SJC] ≥ 1 to ≤ 8; 1–16 total active joints) or oligoarthritis (≥ 1 to ≤ 4 TJC or ≥ 1 to ≤ 4 SJC; 1–8 total active joints) at treatment initiation. Patients were located in the US and Europe (France, Germany, Italy, Spain, and the United Kingdom). Data were collected from cross-sectional questionnaires completed by physicians (assessing treatment effectiveness and satisfaction) and their consulting patients (assessing satisfaction) during their most recent visits. Effectiveness assessments included change in the proportion of patients with dactylitis or enthesitis, mean change in TJC68, SJC66, and physician assessments of pain and fatigue (rated on a 0 to 10 scale) from treatment initiation to the most recent visit, using McNemar or t tests ( P <.05). Additionally, the proportions of patients achieving clinically meaningful improvements, including complete resolution of dactylitis and enthesitis (among patients with dactylitis or enthesitis at treatment initiation), TJC68 and SJC66 (equal to 0 or ≤ 1), and minimal clinically important difference in pain (≥ 1.0-unit decrease) and fatigue (≥ 3.0-unit decrease), were evaluated. Data collected from patient and physician surveys were used to assess satisfaction with disease control following RZB treatment. Outcomes were evaluated in the overall population of patients naïve to biologics with limited joint involvement and in the following subgroups: (1) patients naïve to biologics with limited joint involvement and an inadequate response to ≥ 1 conventional synthetic DMARD (csDMARD-IR), (2) patients with oligoarthritis naïve to biologics, and (3) patients with oligoarthritis naïve to biologics and csDMARD-IR.

Results: The study included 94 biologic-naïve patients (23% [n = 22] from the US, 77% [n = 72] from Europe). Patients were on average 43.3 years old at the time of data collection, 40% were female, and the body surface area affected by psoriasis was 16.1% at treatment initiation. The mean RZB treatment duration was 9.3 months in the overall population with limited joint involvement, and the mean TJC and SJC at treatment initiation was 3.2 and 2.2, respectively. Baseline characteristics were generally similar across the subgroups. Significant improvements in the presence of dactylitis and enthesitis and mean changes in TJC68, SJC66, pain, and fatigue were reported from treatment initiation to the most recent visit for all patient groups (all comparisons, P ≤.001) (Figure 1). High rates of complete resolution of dactylitis (89%) and enthesitis (100%), TJC68 ≤ 1 (69%), SJC66 ≤ 1 (79%), and achievement of clinically meaningful improvements in pain (94%) and fatigue (76%) were observed with RZB treatment in the overall population (Figure 2A). Effectiveness results were consistent in the csDMARD-IR subgroup (n = 65) with limited joint involvement (Figures 1 and 2). Patients with oligoarthritis who presented with dactylitis or enthesitis at treatment initiation, including 100% of both the biologic-naïve (n = 63) and the csDMARDs-IR (n = 46) subgroups, demonstrated complete resolution of dactylitis and enthesitis. Clinically meaningful improvements were also seen in TJC68 ≤ 1 (69% and 73%), SJC66 ≤ 1 (82% for both subgroups), pain (95% and 98%), and fatigue (82% and 89%) in the biologic-naïve and csDMARD-IR oligoarthritis subgroups, respectively (Figure 2B). In the overall population, high satisfaction rates were reported for the ability of RZB to control the disease, with patients (n = 18) and physicians (n = 94) expressing satisfaction rates of 100% and 98%, respectively.

Conclusion: In biologic-naïve patients with PsA and limited joint involvement or oligoarthritis, RZB treatment resulted in significant and clinically meaningful improvements in peripheral joint involvement, pain, and fatigue in real-world clinical practice. Both patients and physicians reported high levels of satisfaction with RZB as a treatment for managing disease in biologic-naïve PsA.

REFERENCES: [1] Dhir V, et al. Clin Rev Allergy Immunol . 2013;44:141-48.

[2] Mease PJ, et al. Ann Rheum Dis. 2024;83:697-98 [Abstract].

[3] Kristensen LE, et al. Ann Rheum Dis. 2022;81:225-31.

[4] Östör A, et al. Ann Rheum Dis. 2022;81:351-58.

Acknowledgements: Data collection was undertaken by Adelphi Real World as part of an independent survey, entitled the Spondyloarthritis (SpA) VI Disease Specific Programme (DSP™). The DSP is a wholly owned Adelphi product and is the intellectual property of Adelphi Real World. The analysis described here used data from the Adelphi SpA VI DSP. AbbVie was one of multiple subscribers to the DSP and did not influence the original survey through either contribution to the design of questionnaires or data collection. All authors had access to the data results and participated in the development, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Matthew Eckwahl, PhD of AbbVie.

Disclosure of Interests: Andrew Ostor has served as a consultant and/or on advisory boards, grant/research support from AbbVie, GSK, Janssen, Lilly, Novartis, and Pfizer, Jessica A. Walsh has received consulting fees from AbbVie, Amgen, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB Pharma, research grants from AbbVie, Amgen, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB Pharma, Christopher D Saffore may hold stock or stock options from AbbVie, employee of AbbVie, Xiaolan Ye may hold stock or stock options from AbbVie, employee of AbbVie, Manish Patel may hold stock or stock options from AbbVie, employee of AbbVie, Ana Biljan may hold stock or stock options from AbbVie, employee of AbbVie, Jamie Vora may hold stock or stock options from AbbVie, employee of AbbVie, Isabel Truman employee of Adelphi Real World, consultant to AbbVie for this analysis, Molly Edwards employee of Adelphi Real World, consultant to AbbVie for this analysis, Gary Milligan employee of Adelphi Real World, consultant to AbbVie for this analysis, William Tillett received speaker fees from AbbVie, Amgen, BMS, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono, Pfizer, and UCB, consulting fees from AbbVie, Amgen, BMS, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono, Pfizer, and UCB, research grants from AbbVie, Amgen, Eli Lilly, Janssen, Pfizer, and UCB.

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