Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON.

IF 5.1 2区医学 Q1 RHEUMATOLOGY

RMD Open Pub Date : 2025-02-23 DOI:10.1136/rmdopen-2024-005086

Yannick Allanore, Madelon C Vonk, Oliver Distler, Arata Azuma, Maureen D Mayes, Alexandra James, Veronika Kohlbrenner, Margarida Alves, Dinesh Khanna, Kristin B Highland

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引用次数: 0

Abstract

Objective: We assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.

Methods: Adverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON ('continued nintedanib' group) and in patients who received placebo in SENSCIS or received nintedanib for ≤28 days in a drug-drug interaction study and then received nintedanib in SENSCIS-ON ('initiated nintedanib' group).

Results: The continued nintedanib group comprised 197 patients, and the initiated nintedanib group comprised 247 patients (231 from SENSCIS). Diarrhoea was the most frequent adverse event, reported in 152 (77.2%) and 183 (74.1%) patients in the continued nintedanib and initiated nintedanib groups, respectively. Among patients in the continued and initiated nintedanib groups, respectively, 53 (26.9%) and 148 (59.9%) had ≥1 dose reduction, 72 (36.5%) and 131 (53.0%) had ≥1 treatment interruption and 29 (14.7%) and 72 (29.1%) had adverse events that led to treatment discontinuation. Mean (SE) changes in FVC (mL) at week 148 were -189.1 (29.5) in the continued nintedanib group and -126.4 (26.4) in the initiated nintedanib group.

Conclusion: The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD.

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持续尼达尼治疗系统性硬化症相关间质性肺病患者：来自sensci - on的3年数据

目的：我们评估开放标签尼达尼布治疗148周SENSCIS- on （SENSCIS试验的延伸）患者的不良事件和强迫肺活量（FVC）的变化。方法：对在sensciis中接受尼达尼布治疗并继续使用尼达尼布治疗的患者（“持续尼达尼”组）和在sensciis中接受安慰剂治疗或在药物相互作用研究中接受尼达尼布治疗≤28天，然后在sensciis - on中接受尼达尼布治疗的患者（“初始尼达尼布组”）进行148周sensciis - on治疗期间的不良事件和FVC变化进行评估。结果：持续尼达尼布组包括197例患者，开始尼达尼布组包括247例患者（231例来自SENSCIS）。腹泻是最常见的不良事件，在持续尼达尼布组和开始尼达尼布组中分别有152例（77.2%）和183例（74.1%）患者报告。在继续和开始尼达尼布组患者中，分别有53例（26.9%）和148例（59.9%）患者剂量减少≥1次，72例（36.5%）和131例（53.0%）患者治疗中断≥1次，29例（14.7%）和72例（29.1%）患者出现不良事件导致治疗中断。第148周，持续尼达尼布组FVC （mL）的平均（SE）变化为-189.1(29.5)，起始尼达尼布组为-126.4（26.4）。结论：尼达尼布在148周sensci - on治疗中的安全性与sensci报告的一致。在sensci和sensci - on期间，FVC的变化支持尼达尼布在减缓肺功能下降方面的持续作用，但显示SSc-ILD的持续进展。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

RMD Open RHEUMATOLOGY-

CiteScore

7.30

自引率

6.50%

发文量

205

审稿时长

14 weeks

期刊介绍： RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.