Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase 3 Results in DMARD-Naive Patients With Psoriatic Arthritis.
The Journal of rheumatology
washington; swedish; seattle
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.
Orthopedics & Sports Medicine
Mease, Philip; Kavanaugh, Arthur; Ogdie, Alexis; Wells, Alvin F; Bergman, Martin; Gladman, Dafna D; Richter, Sven; Teng, Lichen; Jardon, Shauna; and Smolen, Josef S, "Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase 3 Results in DMARD-Naive Patients With Psoriatic Arthritis." (2022). Articles, Abstracts, and Reports. 6009.