POS0665 APREMILAST IMPROVES PATIENT-REPORTED PAIN REGARDLESS OF SEX AND AGE IN EARLY OLIGOARTICULAR PSORIATIC ARTHRITIS: A POST-HOC ANALYSIS FROM FOREMOST

Background: Psoriatic arthritis (PsA) is characterized by pain, fatigue, stiffness, and swelling, with patients reporting pain to be a prominent symptom negatively impacting their quality of life [1]. However, pain in PsA often differs by sex, with females typically reporting higher pain severity and greater disease burden compared with males, highlighting the need for sex-specific analyses in therapeutic studies [2]. Additionally, little is known about how age affects pain in patients with PsA, and if pain in older patients may be recalcitrant to treatment. The FOREMOST study (NCT03747939) presents a unique opportunity to assess patient-reported pain in early oligoarticular (oligo) PsA across sex and age subgroups, and the benefit of apremilast (APR) in improving pain [3]. Understanding responses to treatment by sex and age is critical for optimizing care for patients with oligo PsA. Objectives: This post hoc analysis of FOREMOST assessed changes in patient-reported pain outcomes across sex and age subgroups through 48 weeks and the impact of apremilast treatment. Methods: FOREMOST enrolled 308 patients with early oligo (>1–≤4 swollen and >1–≤4 tender joint count [SJC and TJC]; 66–68 joints assessed) PsA.[3] Patients were randomized 2:1 to APR (n=203) or placebo (PBO; n=105) for 24 weeks (early escape at week 16: PBO patients with no improvement in SJC could switch to APR), followed by an extension phase in which all patients could receive APR through Week 48. Patient-reported pain outcomes included pain visual analogue scale (VAS; 0 to 100 mm, higher scores indicate more pain), PsA Impact of Disease 12-item questionnaire (PsAID-12) pain score (0 [best status] to 10 [worst status]), and 36-item Short Form Survey (SF-36) bodily pain domain score (norm-based, higher scores indicate less pain). We report changes in these pain outcomes through Week 48 by sex and age (<40 years, 40–55 years, and >55 years). Week-16, PBO-controlled data are reported for the full analysis set (N=308); up to Week-48, extension-phase data are reported as observed for N=291 patients who received at least one dose of apremilast during the study, as randomized (APR/APR, n=203) or transitioned from PBO to APR at Week 16 or 24 (PBO/APR, n=88). Results: Of 308 randomized patients (PBO n=105, APR n=203), 169 (54.9%) were females, with uneven distribution between treatment arms: PBO, n=51 (49%) and APR, n=118 (58%). Summarized by age, 67 (21.8%) patients were <40 years (PBO, n=25; APR, n=42), 124 (40.2%) were 40–55 years (PBO, n=41; APR, n=83), and 117 (38.0%) were >55 years (PBO, n=39; APR, n=78). Baseline Pain VAS (mm) for females was higher than males: mean (SE) for females was PBO 54.5 (2.7) and APR 54.1 (2.0); males was PBO 47.9 (3.4) and APR 49.8 (2.4; Figure 1). In general, baseline pain scores were similar across age groups: for example, baseline mean (SE) pain VAS (mm) for <40 years was PBO 42.8 (4.9) and APR 54.5 (3.0), 40–55 years was PBO 53.6 (3.6) and APR 51.8 (2.5), and >55 years was PBO 53.8 (3.3) and APR 51.6 (2.6; Figure 2); patients <40 years randomized to PBO reported lower baseline Pain VAS. At Week 16 and across all sex and age groups, patients reported greater improvements in pain VAS, PsAID-12 pain, and SF-36 bodily pain domain scores with APR versus PBO, with patients <40 years generally reporting the numerically largest differences (Figure 1–2). At Week 16, improvements in pain scores in the PBO arm were greater in patients aged >55 years compared with other age groups (Figure 2). Patients continuing or switching to APR in the extension phase continued to report improvements in pain scores through Week 48, regardless of sex or age (Figures 1–2). Conclusion: In the FOREMOST study of early oligo PsA, APR improved patient-reported pain regardless of sex or age, with sustained benefits through Week 48. Females reported greater baseline burden of PsA-related pain than males. Younger patients showed the numerically largest improvements in pain with APR treatment compared with PBO; however, in the PBO group, older patients experienced greater improvements in pain than younger patients, potentially due to baseline imbalances in patient characteristics affecting pain outcomes, other causes of pain, or comorbidities. These findings highlight the need to better understand factors contributing to pain in PsA to improve patient care. REFERENCES: [1] Gudu and Gossec. Expert Rev Clin Immunol. 2018;14(5):405–417. [2] Passia et al. Arthritis Res Ther. 2022;24(22). [3] Gossec et al. Ann Rheum Dis. 2024;83(11):1480-1488. Acknowledgements: This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Jessica Ma, PhD, employee of and stockholder in Amgen Inc. Disclosure of Interests: Philip J. Mease AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, UCB, Century, Cullinan, Inmagene, Moonlake, Takeda, AbbVie, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Ulrich Mrowietz AbbVie, Aditxt, Almirall, Amgen Inc., Aristea, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dr. Reddy's, Eli Lilly, Foamix, Formycon, Immunic, Janssen, LEO Pharma, Medac, MetrioPharm, Novartis, Phi-Stone, Pierre Fabre, Sanofi-Aventis, UCB Pharma, and UNION Therapeutics, Joseph F Merola AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Janssen, Lilly, MoonLake, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB, Fabian Proft AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hexal, Janssen, Medscape, MSD, Novartis, Pfizer, Roche, and UCB, AbbVie, BMS, Janssen, Novartis, Pfizer, and UCB, Novartis, Eli Lilly, and UCB, Laure Gossec AbbVie, Almirall, AbbVie, Almirall, AbbVie, Almirall, Dafna D. Gladman AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, UCB, AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, UCB, AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, UCB, Arthur Kavanaugh AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, and Pfizer, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, and Pfizer, Siddharth Chaudhari Amgen Inc, Amgen Inc, JIMENA VAZQUEZ Amgen Inc, Amgen Inc, Lichen Teng Amgen Inc, Amgen Inc, Laura C. Coates AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Enlivex, Janssen, Moonlake, Novartis, Pfizer, Takeda, and UCB, Abbvie, Amgen, Janssen, and UCB. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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