Background/Purpose: Apremilast (APR) is associated with comparable ACR response rates in DMARD-naive vs DMARD-experienced patients (pts) with PsA (Wells AF, et al. Rheumatology. 2018;57:1253-63; Kavanaugh A, et al. Arthritis Res Ther. 2019;21:118). A question that remains is if DMARD-naive pts treated with APR have greater chances of achieving treatment targets than DMARD-experienced pts. cDAPSA is a commonly used treatment target. We assessed the predictive value of baseline (BL) clinical disease status on achieving long-term cDAPSA treatment targets at Week 52 among DMARD-naive subjects in PALACE 4; compared these findings vs those recently reported from PALACE 1-3 in subjects with prior exposure to DMARDs; and provided further evidence that at a group level, achievement of cDAPSA disease targets with APR is associated with no or mild articular and extra-articular disease activity by Week 52.

Methods: This post hoc analysis included subjects assigned to APR 30 mg BID at BL who had available cDAPSA data at BL. We calculated the probabilities of shifting across different cDAPSA categories (remission [REM]: ≤4; low disease activity [LDA]: >4 to ≤13; moderate disease activity [Mod]: >13 to ≤27; high disease activity [HDA]: >27 [Machado PM. Ann Rheum Dis. 2016;75:787-790]) from BL to Week 52. Mean values of articular and non-articular variables (PASI, SJC/TJC, MASES, dactylitis) from BL to Week 52 were assessed by cDAPSA category achieved at Week 52 to determine the association between achievement of targets and control of articular and non-articular manifestations. Results from the current analyses were compared with the previously reported results from PALACE 1-3.

Results: A total of 175 subjects receiving APR were included; at BL, 66.3% were in HDA, 31.4% in Mod, and 2.3% were in LDA. Overall, subjects who achieved treatment targets (LDA or REM) by Week 52 had lower levels of disease activity at BL, as shown by a lower number of swollen and tender joints and lower presence of enthesitis and dactylitis. Higher prevalence of psoriasis-involved body surface area ≥3% at BL was observed. Subjects in Mod at BL were estimated to be more than twice as likely to achieve REM or LDA at Week 52 vs subjects in HDA at BL; for subjects in LDA at BL, the estimated probability of achieving cDAPSA treatment targets was 100% (Figure). PALACE 4 subjects with LDA and Mod at BL exhibited higher estimated probabilities of achieving treatment targets (100.0% and 61.7%, respectively) than those observed in the DMARD-experienced population of PALACE 1-3 (71.1% and 46.9%). Subjects in PALACE 4 who achieved REM or LDA by Week 52 showed no or mild articular and extra-articular disease activity by Week 52, similar to what was observed in the PALACE 1-3 population (Mease PJ, et al. Arthritis Care Res. 2020 Jan 7. Epub).

Conclusion: DMARD-naive subjects in PALACE 4 who had LDA or Mod at BL had the highest likelihood of achieving treatment targets (cDAPSA REM or LDA) by Week 52 with continued APR treatment. Results from the current probability analyses revealed higher probability rates than those observed in the DMARD-experienced PALACE 1-3 population; control of articular and extra-articular manifestations was observed in the DMARD-naive and DMARD-experienced populations.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/probability-of-achieving-low-disease-activity-or-remission-with-apremilast-treatment-among-dmard-naive-subjects-with-active-psoriatic-arthritis/