Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis

Abstract

Objective Probability of achieving Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) treatment targets (remission [REM], low disease activity [LDA]) was evaluated following apremilast monotherapy in disease-modifying anti-rheumatic drug (DMARD)-naive patients with psoriatic arthritis (PsA) based on baseline disease activity. Methods This post hoc probability analysis of PALACE 4, a phase 3, multicenter, randomized, placebo-controlled study, evaluated shifting across cDAPSA categories from baseline to Week 52 included DMARD-naive patients receiving apremilast 30 mg BID with available baseline cDAPSA data. Changes in articular/extra-articular manifestations were evaluated in patients with Week 52 cDAPSA components. cDAPSA treatment target achievement was assessed in a subgroup with baseline extra-articular PsA manifestations (skin involvement, enthesitis, dactylitis). Results Of 175 apremilast-treated patients in the probability analysis, 66.3% were in high disease activity (HDA) and 31.4% in moderate disease activity (ModDA) at baseline. Approximately twice as many patients in ModDA at baseline reached REM/LDA at Week 52 vs those in HDA (61.7% vs 28.2%). Achieving cDAPSA treatment targets was associated with reductions in articular (swollen/tender joints) and extraarticular (skin involvement, enthesitis, dactylitis, functional disability) disease activity. Similar treatment target achievement rates were observed in the subgroup with ≥1 extra-articular PsA manifestation (n=126; ModDA: 66.7%, HDA: 32.2%). Conclusion Apremilast-treated patients with baseline ModDA had higher probability of achieving cDAPSA treatment targets than patients with HDA. Resolution/near resolution of articular/extra-articular PsA manifestations was achieved by patients in REM/LDA at Week 52. Consistent treatment target achievement was observed in patients with 1 or multiple extra-articular manifestations of active PsA.

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study

“…In that study, female sex was a strong negative predictor of DAPSA response; however, the authors analyzed only a shorter-term endpoint (3 months) and baseline disease activity was not evaluated. On the other hand, similarly to what was observed in our cohort of PsA patients, the post hoc analyses of PALACE 1-3 studies and PALACE 4 study clearly highlighted that the probability of achieving cDAPSA low disease activity or remission at week 52 was greater for patients with moderate versus high disease activity at baseline [7,8].…”

“…A direct comparison with the other real-world studies is not possible since they did not report DAPSA response; however, improvements in symptoms were described in 43.5-60.9% of patients [12,13]. Two recent post hoc analyses of the PALACE 1-3 studies and PALACE 4 study reported 52 weeks of cDAPSA low disease activity or remission, respectively, in 39.4% and 44.9% of PsA patients treated with apremilast [7,8]. When comparing these rates to the one reported in our cohort of patients, it appears to be similar, although slightly higher (54.9%).…”

“…Moreover, the probability of achieving low disease activity or remission was greater for patients with baseline moderate versus high disease activity [7]. Similarly, a post hoc analysis of the PALACE 4 study reported that 62/138 (44.9%) PsA patients achieved a cDAPSA low disease activity or remission at 52 weeks of treatment with apremiliast, with higher probability for those with baseline moderate disease activity [8].…”