在SPIRIT试验中，Ixekizumab治疗银屑病关节炎患者的滑膜炎、胃炎和患者报告结果的协同改善

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2025-04-01 Epub Date: 2025-02-27 DOI:10.1007/s40744-025-00748-8

Lars-Erik Kristensen, Dennis McGonagle, Martin Rudwaleit, Hideto Kameda, Peter Adler Würtzen, Marcus Ngantcha, Thorsten Holzkämper, Josef Smolen

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引用次数: 0

摘要

滑膜炎和肌炎是银屑病关节炎（PsA）的主要表现。这项描述性分析调查了单独和联合的滑膜炎和腱鞘炎的改善与患者报告的结果（PROs）的改善之间的关系，包括基线时出现滑膜炎和腱鞘炎并接受ixekizumab （IXE）治疗的SPIRIT-P1、SPIRIT-P2和SPIRIT-H2H试验中PsA患者的健康相关生活质量（HRQoL）的改善。方法：在这项事后分析中，数据来自两项III期研究（SPIRIT-P1和SPIRIT-P2）和一项IIIb/IV期研究（SPIRIT-H2H）中每4周接受IXE治疗的PsA患者，这些患者在基线时同时患有滑膜炎和鼻炎。通过第52周的Pearson分析探讨滑膜炎的改善和肌炎的改善之间的关系。到第52周，对两种、两种和两种情况的改善与PROs（36项简短健康调查物理成分评分[sf - 36pcs]、欧洲生活质量5维度5水平[EQ-5D- 5l]，包括EQ-5D视觉模拟评分[VAS]和eq -健康指数、患者整体评估[PtGA]和疼痛VAS）的改善之间的关系进行描述性评估。结果：结果显示，到第52周，IXE治疗的患者滑膜炎和腱鞘炎（单独或联合）均有协同改善，包括HRQoL在内的PROs也有改善。在第52周观察到滑膜炎和腱鞘炎症状的改善之间的关联。滑膜炎和腱鞘炎均得到缓解的患者报告SF-36 PCS、EQ-5D-5L、疼痛VAS和PtGA的改善最大。结论：到第52周，IXE治疗的PsA患者在两个关键PsA域（滑膜炎和肌炎）和PROs（包括HRQoL）的改善中观察到协同改善。这些发现支持PsA治疗目标，即在所有疾病域中实现尽可能低的疾病活动水平。试验注册号：SPIRIT-P1 （NCT01695239）、SPIRIT-P2 （NCT02349295）和SPIRIT-H2H （NCT03151551）。

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Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials.

Introduction: Synovitis and enthesitis are key manifestations in psoriatic arthritis (PsA). This descriptive analysis investigated the association between improvement in synovitis and enthesitis, individually and combined, and improvement in patient-reported outcomes (PROs) including health-related quality of life (HRQoL) for patients with PsA from the SPIRIT-P1, SPIRIT-P2, and SPIRIT-H2H trials who presented with synovitis and enthesitis at baseline and received ixekizumab (IXE) treatment.

Methods: In this post hoc analysis, data are presented from patients with PsA treated with IXE every 4 weeks from two phase III studies (SPIRIT-P1 and SPIRIT-P2) and one phase IIIb/IV study (SPIRIT-H2H) who had both synovitis and enthesitis at baseline. Associations between improvements in synovitis and improvements in enthesitis were explored using Pearson analyses through week 52. Associations between improvements in both, either, and neither condition with improvements in PROs (36-item Short Form Health Survey Physical Component Score [SF-36 PCS], the European Quality-of-Life 5 Dimensions 5 Levels [EQ-5D-5L] including the EQ-5D Visual Analogue Score [VAS] and the EQ-health index, Patient's Global Assessment [PtGA], and pain VAS) were assessed descriptively through week 52.

Results: Results demonstrated the synergistic improvements in synovitis and enthesitis, individually or combined, and improvements in PROs including HRQoL, for patients treated with IXE through week 52. An association between improvements in synovitis and enthesitis symptoms was observed through week 52. Patients who achieved resolution of both synovitis and enthesitis reported highest improvements in SF-36 PCS, EQ-5D-5L, pain VAS, and PtGA.

Conclusion: Synergistic improvements in two key PsA domains, namely synovitis and enthesitis, and improvements in PROs including HRQoL, were observed for patients with PsA treated with IXE through week 52. These findings support PsA treatment goal aiming to achieve the lowest possible level of disease activity in all disease domains.

Trial registration numbers: SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295), and SPIRIT-H2H (NCT03151551).

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. 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