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基线疾病活动度可预测阿普米司特治疗银屑病关节炎患者的 cDAPSA 治疗目标达标情况:III 期 DMARD 初治患者结果。

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

机构信息

P.J. Mease, MD, Swedish Medical Center/Providence St.Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA;

A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA.

出版信息

J Rheumatol. 2022 Jul;49(7):694-699. doi: 10.3899/jrheum.210906. Epub 2022 Apr 15.

DOI:10.3899/jrheum.210906
PMID:35428720
Abstract

OBJECTIVE

The 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 antirheumatic drug (DMARD)-naïve patients with psoriatic arthritis (PsA) based on baseline disease activity.

METHODS

This post hoc probability analysis of PALACE 4, a phase III, multicenter, randomized, placebo-controlled study, evaluated shifting across cDAPSA categories from baseline to week 52 and included DMARD-naïve patients receiving apremilast 30 mg BID with available baseline cDAPSA data. Changes in articular/extraarticular manifestations were evaluated in patients with week 52 cDAPSA components. cDAPSA treatment target achievement was assessed in a subgroup with baseline extraarticular 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 extraarticular 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 and/or near resolution of articular and/or extraarticular PsA manifestations was achieved by patients in REM/LDA at week 52. Consistent treatment target achievement was observed in patients with 1 or multiple extraarticular manifestations of active PsA.

摘要

目的

根据基线疾病活动情况,评估初治的、接受阿普司特单药治疗的银屑病关节炎(PsA)患者达到银屑病关节炎临床疾病活动指数(cDAPSA)治疗目标(缓解[REM]、低疾病活动[LDA])的概率。

方法

这是一项 III 期、多中心、随机、安慰剂对照研究 PALACE 4 的事后概率分析,评估了从基线到第 52 周时 cDAPSA 类别变化情况,纳入了接受阿普司特 30mg,每日 2 次治疗且基线 cDAPSA 数据可用的初治患者。在第 52 周 cDAPSA 各组成部分患者中评估关节/关节外表现的变化。在基线有关节外 PsA 表现(皮肤受累、附着点炎、指炎)的亚组中评估 cDAPSA 治疗目标的实现情况。

结果

在概率分析中,175 名接受阿普司特治疗的患者中,66.3%在基线时处于高度疾病活动(HDA),31.4%处于中度疾病活动(ModDA)。与基线 HDA 相比,基线 ModDA 的患者在第 52 周时达到 REM/LDA 的比例约为后者的两倍(61.7% vs 28.2%)。达到 cDAPSA 治疗目标与关节(肿胀/压痛关节)和关节外(皮肤受累、附着点炎、指炎、功能障碍)疾病活动的降低相关。在基线有≥1 个关节外 PsA 表现的亚组中(n=126;ModDA:66.7%,HDA:32.2%),也观察到了相似的治疗目标实现率。

结论

与基线 HDA 患者相比,基线 ModDA 的阿普司特治疗患者达到 cDAPSA 治疗目标的可能性更高。在第 52 周时,处于 REM/LDA 的患者达到了关节和/或关节外 PsA 表现的缓解和/或接近缓解。在有 1 个或多个活跃的关节外 PsA 表现的患者中,观察到了一致的治疗目标实现率。

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