APREMILAST TREATMENT IN EARLY OLIGOARTICULAR PSORIATIC ARTHRITIS (PSA) IMPROVES CLINICAL AND PATIENT-REPORTED OUTCOMES FOR UP TO 48 WEEKS - DATA FROM THE FOREMOST STUDY

Background: Most clinical trials of PsA exclude patients (pts) with early oligoarticular (oligo) disease and there is limited evidence to drive treatment decisions in this setting. Objectives: We report 48-week (wk) efficacy and safety of apremilast (APR) vs placebo (PBO) in pts with early oligo PsA. Methods: FOREMOST (NCT03747939), a multicenter, randomized, double-blind, PBO-controlled trial (RCT), included pts with early PsA (duration ≤5 years) and limited joint involvement (>1–≤4 swollen and >1–≤4 tender joint count [SJC and TJC]; 66–68 joints assessed; affected joints defined as sentinel). Pts were randomized 2:1 to APR (30 mg BID) or PBO for 24 wks (early escape at Wk 16), followed by an extension phase in which all pts received APR through Wk 48. Primary endpoint was modified minimal disease activity (MDA-Joints) in sentinel joints at Wk 16, defined as SJC ≤1, TJC ≤1, and 3 of the following: psoriasis Body Surface Area ≤3%, Health Assessment Questionnaire–Disability Index (HAQ–DI) ≤0.5, pt global visual analogue scale [VAS; 0-100] ≤20, pt pain VAS ≤15, Leeds Enthesitis Index ≤1 . Post hoc analysis assessed (original) MDA (cut offs for 5 of the 7 MDA domains met), mean SJC and TJC, and change in SJC/TJC over 48 wks (all joints). Exploratory outcomes (summarized for pts entering the extension phase; data as observed) included MDA-Joints, clinical Disease Activity Index for PsA (cDAPSA) remission (REM ≤4) or low disease activity (LDA >4-≤13), PsA Impact of Disease 12-item questionnaire (PsAID-12) ≤4 and HAQ-DI ≤0.5 over 48 wks. Results: 308 pts were randomized (APR: n=203; PBO: n=105); mean PsA duration at baseline, 9.9 months; 39.9% receiving a conventional systemic disease-modifying antirheumatic drug; mean SJC, 2.6; mean TJC, 3.2; mean HAQ-DI, 1.0. As reported previously, significantly more pts achieved the primary outcome of MDA-Joints at Wk 16 with APR vs PBO (33.9% vs 16.0%; p =0.0008]) . A similar result was observed for MDA at Wk 16 (38.1% vs 21.0%; [nominal] p =0.0023; non-responder/multiple imputation; sentinel joints). Among pts who received ≥1 dose of APR in the study (initiated at baseline, W16 or W24), 46.2% of those initially randomized to APR (APR/APR) and 50% of pts switched from PBO to APR at W16 or W24 (PBO/APR) achieved MDA (all joints) at Wk 48. During the PBO-controlled phase, mean SJC and TJC improved in the APR group and worsened in the PBO group; further improvements were observed among pts receiving APR to Wk 48 ( Figure 1A-B ). Among pts in the PBO group with 2-4 joints affected at baseline, over one-third moved to a joint count >4 at Wk 16; sustained treatment benefit was observed when these pts switched to APR, with fewer pts moving to a joint count >4 ( Figure 1C ). Improvements in other clinical and pt-reported outcomes observed at Wk 16 were sustained at Wk 48 with APR ( Table 1 ), with no new safety signals. Figure 1. Table 1. Clinical and patient-reported outcomes at Weeks 16 and 48 Wk 16 Wk 48 PBO (N=88 ) APR (N=203 ) PBO/APR (N=88) APR (N=203 ) cDAPSA* REM/LDA, n/N (%) 29/60 (48.3) 96/135 (71.1) 40/52 (76.9) 81/100 (81.0) PsAID-12 ≤4 , n/N (% ) 14/54 (25.9) 62/116 (53.4) 24/47 (51.1) 50/84 (59.5) HAQ ≤0.5 , n/N (% ) 13/62 (21.0) 43/123 (35.0) 23/55 (41.8) 34/90 (37.8) N=number of pts randomized to PBO/APR and received ≥ 1 APR dose regardless of when apremilast started (Baseline, Week 16, or Week 24). Assessed in patients with *cDAPSA>13 (moderate disease activity); †PsAID-12 >4; ‡HAQ-DI >0.5 at baseline. Data as observed. Conclusion: In pts with early oligo PsA, APR treatment led to early improvements in clinical and patient-reported outcomes, including the treatment goal of MDA. These benefits were sustained and further improved over 48 wks with no new safety signals. To our knowledge, this is the first evidence from a RCT that could be used to inform treatment decisions in pts with early oligo PsA. REFERENCES: [1] Coates LC, Helliwell PS. J Rheumatol. 2016;43(2):371-5. [2] Gossec L, Gladman D, Coates L, et al. Presented at: Annual Congress of the European Academy of Dermatology and Venereology; 11-14 October 2023; Berlin, Germany. Acknowledgements: This study was sponsored by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Rebecca Lane, PhD of Peloton Advantage, LLC, an OPEN Health company, and Claire Desborough, MSc, employee of and stockholder in Amgen Inc. Disclosure of Interests: Laure Gossec AbbVie, Biogen, Lilly, Novartis, UCB – grant/research support; AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB – personal fees; AbbVie, Janssen, MSD, Novartis, Pfizer, UCB – nonfinancial support., Laura C. Coates AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, and UCB – grant/research support, consulting fees, and/or speaker/honoraria, AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB –grant/research support, consulting fees, and/or speaker honoraria. LCC was supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author and not necessarily those of the NHS, the NIHR, or the Department of Health., AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB –grant/research support, consulting fees, and/or speaker honoraria. LCC was supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author and not necessarily those of the NHS, the NIHR, or the Department of Health., Dafna D. Gladman AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB – grant/research support or consulting fees, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB – grant/research support or consulting fees, Alexis Ogdie AbbVie, Amgen Inc., Bristol Myers Squibb, CorEvitas’ Psoriatic Arthritis/Spondyloarthritis Registry, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB, and Takeda – consultant, AbbVie, Amgen Inc., BMS, Janssen, Novartis, and Pfizer – grant/research support, Alvin Wells AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB – consultant and speakers bureau, AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB – consultant and speakers bureau, AbbVie, Celgene, and Lilly – grant/research support, Joseph F Merola AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, and UCB – consultant and/or investigator, Paolo Gisondi AbbVie, Amgen Inc., Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, and UCB –consultant and grant/research support, AbbVie, Amgen Inc., Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, and UCB –consultant and grant/research support, Andreas Pinter AbbVie, Allmirall-Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, GSK, Eli Lilly, Eva Pharma, Galderma, Hexal, Janssen, LEO Pharma, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Schering-Plough, UCB Pharma, and Zuellig Pharma – investigator, speaker, and/or advisor. Mitsumasa Kishimoto received consulting fees and/or honoraria from AbbVie, Amgen, Asahi-Kasei Pharma, Ayumi Pharma, BMS, Chugai, Daiichi Sankyo, Eisai, Gilead, Janssen, Lilly, Novartis, Pfizer, Tanabe-Mitsubishi, and UCB., Jyotsna Reddy Amgen Inc: employment and stock ownership, Amgen Inc: employment and stock ownership, Hamid Amouzadeh Amgen Inc: employment and stock ownership, Amgen Inc: employment and stock ownership, Rebecca Wang Amgen Inc: employment and stock ownership, Amgen Inc: employment and stock ownership, Shauna Jardon Amgen Inc: employment and stock ownership, Amgen Inc: employment and stock ownership, Michele Brunori Amgen Inc: employment and stock ownership, Amgen Inc: employment and stock ownership, Philip J. Mease Boehringer Ingelheim, GlaxoSmithKline – consultant; AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB – speakers bureau., AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB – grant/research support and consultant;, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB – grant/research support and consultant; DOI: 10.1136/annrheumdis-2024-eular.1251 Keywords: Clinical Trial, Remission, Randomized controlled trial, Quality of life Citation: , volume 83, supplement 1, year 2024, page 692Session: Psoriatic arthritis (Poster View)

Clinical Trial, Remission, Randomized controlled trial, Quality of life