Impact of Baseline Factors on Disease Progression and Apremilast Efficacy in Early Oligoarticular Psoriatic Arthritis

Philip Mease¹, Laura Coates², Alexis Ogdie³, Dafna Gladman⁴, Alen Zabotti⁵, Xenofon Baraliakos⁶, Cynthia Deignan⁷, Shauna Jardon⁷, Rebecca Wang⁷, Lichen Teng⁷ and Laure Gossec⁸, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ³Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁴University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁵Azienda Sanitaria Universitaria del Friuli Centrale, Udine, Udine, Italy, ⁶Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Sorbonne Université, Paris, France

Meeting: ACR Convergence 2024

Keywords: Psoriatic arthritis, Randomized Trial, risk factors

Session Information

Date: Monday, November 18, 2024

Title: SpA Including PsA – Treatment Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: In the FOREMOST study of early oligoarticular psoriatic arthritis (PsA), fewer patients (pts) receiving apremilast (APR) progressed from ≤4 active joints (all joints; oligoarthritis) to >4 (polyarthritis) over 16 weeks compared with placebo (PBO). FOREMOST offers a unique opportunity to identify baseline characteristics associated with disease progression from ≤4 active joints to >4 joints, as well as the ability of APR to impact disease progression.

Methods: FOREMOST (NCT03747939), a multicenter, randomized, double-blind, PBO-controlled trial, 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). Pts were randomized 2:1 to APR (30 mg BID) or PBO for 24 weeks (early escape at Week [W] 16), followed by an extension phase in which all pts received APR through W48. This post hoc analysis assessed the percentage of pts with an active (swollen and/or tender) joint count ≤4 at baseline who progressed to an active joint count >4 at W16 stratified by baseline characteristics. Clinically relevant demographic/disease characteristics with reasonable sample size were selected from all available baseline data. Data are reported as observed.

Results: Of 308 pts randomized (APR, n=203; PBO, n=105), most (268/308 [87%]) had ≤4 active joints at baseline (APR, n=176; PBO, n=92). Baseline demographics/disease characteristics were generally similar between the APR and PBO groups, with the exception of a higher proportion of females in the APR group (58.5% vs 48.9%). Compared with APR, a higher proportion of pts in the PBO group progressed to >4 active joints at W16 (34.9% vs 19.7%; treatment difference: -14.8%) (previously published; Figure 1). This trend was consistent across baseline demographic/disease characteristic subgroups (Figures 2 and 3). Female pts were more likely to progress to >4 active joints than male pts (APR, 25.0% vs 12.5%; PBO, 51.3% vs 20.5%), and a greater treatment difference was observed in females (-26.5 vs -9.2; Figure 2). Treatment differences were consistent regardless of baseline body mass index (Figure 2). Greater treatment differences were observed in pts who had not previously or were not currently using conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) compared with those who were (Figure 2). Pts with enthesitis at baseline were more likely to progress to >4 active joints than those without (Figure 2), with a treatment difference observed when enthesitis was measured by Leeds Enthesitis Index (LEI; -27.2% vs -11.5%) but not when measured by Spondyloarthritis Research Consortium of Canada Index (SPARCC; -15.6% vs -14.7%). Greater treatment differences were seen in pts without nail psoriasis versus those with nail psoriasis (-27.1% vs -10.5%) (Figure 2).

Conclusion: In FOREMOST, being female, having more active joints, or having enthesitis were identified as demographic/disease characteristics associated with disease progression from ≤4 to >4 active joints in early oligoarticular PsA. APR reduced disease progression after 16 weeks compared with PBO, with larger treatment differences observed across a number of demographic/disease characteristics.

FAS with ≤4 active (swollen and/or tender) joints at baseline; data as observed and based on all joints. Error bars represent SE. FAS, full anlaysis set.

Data as observed and based on all joints.
cDAPSA scores >4 to ≤13 indicate low disease activity; scores >13 to ≤27 indicate moderate disease activity. PASDAS scores ≥5.4 indicate high disease activity.
APR, aremilast; BMI, body mass index; cDAPSA, clinical Disease Activity in Psoriatic Arthritis; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; LEI, Leeds Enthesitis Index; PASDAS, Psoriatic Arthritis Disease Activity Score; PBO, placebo; SPARCC, Spondyloarthritis Research Consortium of Canada Index.

Data as observed and based on all joints.
HAQ-DI, Health Assessment Questionnaire-Disability Index; PASS, Patient-Acceptable Symptom State; PsAID_12, Psoriatic Arthritis Impact of Disease 12-Item; PtGA, Patient Global Assessment of Disease Activity; VAS, visual analog scale.

Disclosures: P. Mease: AbbVie, 2, 5, Aclaris Therapeutics, 2, 5, Aclyrin, 2, 5, Amgen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, CorEvitas, 2, 5, Galápagos, 2, 5, Gilead, 2, 5, Inmagene, 2, 5, Janssen, 2, 5, Lilly, 2, 5, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, Sun Pharma, 2, 5, UCB, 2, 5; L. Coates: AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Biogen, 6, Bristol Myers Squibb, 2, Celgene, 2, 5, 6, Eli Lilly, 2, 5, 6, Galapagos, 2, 6, Gilead, 2, 6, GSK, 6, Janssen, 2, 5, 6, Medac, 6, MoonLake, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6; A. Ogdie: AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb(BMS), 5, Celgene, 2, CorEvitas, 2, Eli Lilly, 2, Gilead, 2, GlaxoSmithKlein(GSK), 5, Happify Health, 2, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2; D. Gladman: AbbVie, 2, 5, Amgen, 2, 5, AstraZeneca, 2, BMS, 2, Celgene, 2, 5, Eli Lilly, 2, 5, Galapagos, 2, 5, Gilead, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5; A. Zabotti: AbbVie, 6, Amgen, 6, Johnson and Johnson, 5, 6, Lilly, 6, Novartis, 5, 6, UCB, 6; X. Baraliakos: AbbVie, 2, 6, 12, Paid instructor, BMS, 2, 6, 12, Paid instructor, Chugai, 2, 6, 12, Paid instructor, Eli Lilly, 2, 6, 12, Paid instructor, Galapagos, 2, 6, 12, Paid instructor, Gilead, 2, MSD, 6, 12, Paid instructor, Novartis, 2, 5, 6, 12, Paid instructor, Pfizer, 2, 6, 12, Paid instructor, UCB Pharma, 2, 5, 6, 12, Paid instructor; C. Deignan: Amgen, 3, 12, Own company stock; S. Jardon: Amgen, 3; R. Wang: Amgen, 3, 11; L. Teng: Amgen, 3, 11; L. Gossec: AbbVie, 2, 5, Amgen, 2, Biogen, 5, Bristol-Myers Squibb (BMS), 2, Celltrion, 2, Eli Lilly, 2, 5, Galapagos, 2, Janssen, 2, MSD, 2, Novartis, 2, 5, Pfizer, 2, Sandoz, 2, UCB, 2, 5.

To cite this abstract in AMA style:

Mease P, Coates L, Ogdie A, Gladman D, Zabotti A, Baraliakos X, Deignan C, Jardon S, Wang R, Teng L, Gossec L. Impact of Baseline Factors on Disease Progression and Apremilast Efficacy in Early Oligoarticular Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/impact-of-baseline-factors-on-disease-progression-and-apremilast-efficacy-in-early-oligoarticular-psoriatic-arthritis/. Accessed .

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