Session Type: Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: The modified minimal disease activity (MDA-Joints) is a novel composite endpoint to assess disease activity and treatment effect in PsA based on a criteria set of mandated tender and swollen joints, and 3/5 items of skin involvement, patient assessments, functionality, and enthesitis.1 FOREMOST evaluated apremilast 30 mg BID (APR) treatment by MDA-Joints in patients (pts) with early oligoarticular (oligo) PsA.
Methods: FOREMOST (NCT03747939) is a phase 4, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group study. Eligible pts had early disease (PsA duration ≤5 years) and oligo PsA ( >1 but ≤4 tender and >1 but ≤4 swollen joint count [TJC and SJC]) despite prior treatment with either nonsteroidal anti-inflammatory drugs and/or ≤2 conventional systemic disease-modifying antirheumatic drugs. Pts were randomized 2:1 to APR or PBO (stratified by concomitant medication use) for 24 weeks, with an early escape at Week 16. The primary endpoint was the proportion of pts at Week 16 who achieved MDA-Joints, a composite of TJC ≤1 and SJC ≤1 plus achieving 3 of the following: psoriasis body surface area (BSA) ≤3%, pt assessment of pain visual analog scale (0–100-mm) ≤15, Pt Global Assessment of Disease Activity (PtGA; 0–100-mm) ≤20, health assessment questionnaire disability index (HAQ-DI) ≤0.5, and enthesitis count ≤1 based on the Leeds Enthesitis Index (LEI). This analysis assesses achievement of each domain in the overall population and only among those with baseline (BL) disease activity. All P-values are nominal.
Results: BL values for the overall population and all MDA-Joints domains were comparable between APR and PBO groups (Table 1). Improvements were observed across all domains for the entire cohort. In the overall population, more pts achieved TJC ≤1 (66.2% vs 44.4%), SJC ≤1 (74.0% vs 69.0%), BSA ≤3% (70.8% vs 60.5%), pt assessment of pain ≤15 (29.4% vs 13.1%), PtGA ≤20 (30.4% vs 19.1%), HAQ-DI ≤0.5 (47.5% vs 34.2%), and LEI ≤1 (76.0% vs 71.3%) at Week 16 with APR vs PBO. Of pts with BSA >3% at BL, significantly more achieved BSA ≤3% with APR vs PBO at Week 16 (52.2% vs 25.1%; P=0.0043) (Figure 1). Of pts with a pt assessment of pain score >15 at BL, pt assessment of pain ≤15 was reached by significantly more patients with APR vs PBO at Week 16 (27.1% vs 9.9%; P=0.0012) (Figure 1). Of pts with PtGA >20 at BL, significantly more achieved PtGA ≤20 at Week 16 with APR vs PBO (28.5% vs 13.0%; P=0.0044) (Figure 1). Of pts with HAQ-DI >0.5 at BL, 32.4% and 19.0% achieved HAQ-DI ≤0.5 at Week 16 with APR and PBO, respectively (P=0.0302) (Figure 1). Of pts with LEI >1 at BL, numerically greater proportions achieved LEI ≤1 at Week 16 with APR vs PBO, although this was not significant (53.1% vs 41.0%; P=0.3815) (Figure 1).
Conclusion: Improvements were seen in all MDA-Joints domains with APR vs PBO at Week 16 in pts with early oligo PsA who did not meet any of the thresholds at BL. Improvements were significantly greater for TJC, BSA, pt assessment of pain, PtGA, and HAQ-DI domains and numerically greater for the SJC and LEI domains with APR treatment compared with PBO, possibly related to the small sample size.
To cite this abstract in AMA style:Mease P, Ogdie A, Callis Duffin K, Reddy J, Wang R, Jardon S, Coates L. Effect of Apremilast Treatment on the Domains of MDA-Joints in Patients with Early Oligoarticular Psoriatic Arthritis: 16-Week Results from FOREMOST [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/effect-of-apremilast-treatment-on-the-domains-of-mda-joints-in-patients-with-early-oligoarticular-psoriatic-arthritis-16-week-results-from-foremost/. Accessed .
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