阿普司特在实际临床环境中对附着点炎和指（趾）炎的治疗效果：一项意大利多中心研究

Therapeutic Effects of Apremilast on Enthesitis and Dactylitis in Real Clinical Setting: An Italian Multicenter Study.

作者信息

Lo Gullo Alberto, Becciolini Andrea, Parisi Simone, Del Medico Patrizia, Farina Antonella, Visalli Elisa, Dal Bosco Ylenia, Molica Colella Aldo Biagio, Lumetti Federica, Caccavale Rosalba, Scolieri Palma, Andracco Romina, Girelli Francesco, Bravi Elena, Colina Matteo, Volpe Alessandro, Ianniello Aurora, Ditto Maria Chiara, Nucera Valeria, Franchina Veronica, Platé Ilaria, Di Donato Eleonora, Amato Giorgio, Salvarani Carlo, Bernardi Simone, Lucchini Gianluca, De Lucia Francesco, Molica Colella Francesco, Santilli Daniele, Mansueto Natalia, Ferrero Giulio, Marchetta Antonio, Arrigoni Eugenio, Foti Rosario, Sandri Gilda, Bruzzese Vincenzo, Paroli Marino, Fusaro Enrico, Ariani Alarico

机构信息

Unit of Rheumatology, Department of Medicine, ARNAS "Garibaldi", 95124 Catania, Italy.

Internal Medicine and Rheumatology, Department of Medicine, Azienda Ospedaliera Di Parma, 43126 Parma, Italy.

出版信息

J Clin Med. 2023 Jun 7;12(12):3892. doi: 10.3390/jcm12123892.

DOI:10.3390/jcm12123892

PMID:37373587

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10299365/

Abstract

INTRODUCTION

Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life.

OBJECTIVE

The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast.

METHODS

Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann-Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A -value of <0.05 was considered statistically significant.

RESULTS

The Eph cohort consisted of 118 patients (median LEI 3); the Dph cohort included 96 patients with a median dactylitis of 1 (IQR 1-2). According to an intention to treat analysis, 25% and 34% of patients with enthesitis achieved remission (i.e., LEI = 0) in T1 and T2. The remission of dactylitis was 47% in T1 and 44% in T2. The per protocol analysis (patients observed for at least 12 months) showed that both dactylitis and LEI significantly improved in T1 (median LEI 1 (IQR 1-3)) and T2 (median LEI 0 (IQR 1-2)).

CONCLUSION

Eph and Dph PsA patients treated with apremilast experienced a significant improvement in enthesitis and dactylitis activity. After 1 year, enthesitis and dactylitis remission was achieved in more than one-third of patients.

摘要

引言

附着点炎和指（趾）炎是银屑病关节炎（PsA）难以治疗的特征，会导致残疾并影响生活质量。

目的

本研究旨在评估接受阿普米拉斯治疗的患者在6个月和12个月时的附着点炎（使用利兹附着点炎指数（LEI））和指（趾）炎情况。

方法

对来自15个意大利风湿病转诊中心的PsA患者进行筛查。纳入标准为：（a）附着点炎或指（趾）炎表型；（b）接受阿普米拉斯30 mg每日两次治疗。记录临床和治疗史，包括PsA疾病活动情况。使用曼-惠特尼检验和卡方检验评估独立组之间的差异，使用威尔科克森配对符号秩检验评估相关样本之间的差异。P值<0.05被认为具有统计学意义。

结果

附着点炎队列由118名患者组成（LEI中位数为3）；指（趾）炎队列包括96名患者，指（趾）炎中位数为1（四分位间距1 - 2）。根据意向性分析，25%和34%的附着点炎患者在T1和T2时达到缓解（即LEI = 0）。指（趾）炎在T1时的缓解率为47%，在T2时为44%。符合方案分析（观察至少12个月的患者）显示，指（趾）炎和LEI在T1（LEI中位数1（四分位间距1 - 3））和T2（LEI中位数0（四分位间距1 - 2））时均有显著改善。