Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from SENSCIS-ON.
Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from SENSCIS-ON.
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DOI：
10.1136/ard-2022-222564
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发表时间：
2022-12
影响因子：
27.4
通讯作者：
中科院分区：
文献类型：
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作者：
在SENSCIS对系统性硬化症相关性间质性肺病(SSC-ILD)患者的试验中，与安慰剂相比，9tedanib降低了用力肺活量(FVC)的下降速度，不良事件对大多数患者来说是可控的。一项名为SENSCIS-ON的开放标签扩展试验正在评估较长期的九替达尼治疗期间的安全性和FVC下降。完成SENSCIS试验或九替丹尼和口服避孕药治疗的药物-药物相互作用(DDI)研究的患者有资格参加SENSCIS-ON。在SENSCIS-ON试验中接受9tedanib治疗并在SENSCIS-ON试验中继续服用9tedanib的患者(“继续服用9tedanib”组)和在SENSCIS-ON试验中接受安慰剂治疗并在SENSCIS-ON试验中开始服用9tedanib的患者(在DDI研究中接受9tedanib治疗28天的患者)，评估了在SENSCIS-ON试验中接受9tedanib治疗并在SENSCIS-ON试验中继续服用9tedanib的患者的不良事件和FVC的变化。继续服用9tedanib组有197名患者，开始服用9tedanib组有247名患者。在这些组中，分别有68.0%和68.8%的患者报告有腹泻。不良事件导致在继续服用9tedanib组和开始使用9tedanib组中，分别有4.6%和21.5%的患者停止使用9tedanib。从治疗前到治疗52周，持续用药组的用力肺活量(−)平均变化为58.3(15.5)毫升，开始用药组(−)为44.0(16.2)毫升。在服用SENSCIS-ON的52周内，九替丹尼的安全性与SENSCIS中报道的一致。在SENSCIS-ON的52周内，FVC的变化与SENSCIS的9tedanib组相似。
In the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) versus placebo, with adverse events that were manageable for most patients. An open-label extension trial, SENSCIS-ON, is assessing safety and FVC decline during longer term nintedanib treatment. Patients who completed the SENSCIS trial or a drug–drug interaction (DDI) study of nintedanib and oral contraceptive on treatment were eligible to enter SENSCIS-ON. Adverse events and changes in FVC over 52 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 and initiated nintedanib in SENSCIS-ON or who received nintedanib for ≤28 days in the DDI study (’initiated nintedanib’ group). There were 197 patients in the continued nintedanib group and 247 in the initiated nintedanib group. Diarrhoea was reported in 68.0% and 68.8% of patients in these groups, respectively. Adverse events led to discontinuation of nintedanib in 4.6% and 21.5% of the continued nintedanib and initiated nintedanib groups, respectively. Mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were −58.3 (15.5) mL in the continued nintedanib group and −44.0 (16.2) mL in the initiated nintedanib group. The safety profile of nintedanib over 52 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. The change in FVC over 52 weeks of SENSCIS-ON was similar to that observed in the nintedanib group of SENSCIS.
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影响因子：
27.4
作者：
Hoffmann-Vold AM;Allanore Y;Alves M;Brunborg C;Airó P;Ananieva LP;Czirják L;Guiducci S;Hachulla E;Li M;Mihai C;Riemekasten G;Sfikakis PP;Kowal-Bielecka O;Riccardi A;Distler O;EUSTAR collaborators
通讯作者：
EUSTAR collaborators
影响因子：
27.4
作者：
van den Hoogen, Frank;Khanna, Dinesh;Pope, Janet E.
通讯作者：
Pope, Janet E.
DOI：
10.1002/art.41933
发表时间：
2022-01
期刊：
Arthritis & rheumatology (Hoboken, N.J.)
影响因子：
--
作者：
Khanna D;Lescoat A;Roofeh D;Bernstein EJ;Kazerooni EA;Roth MD;Martinez F;Flaherty KR;Denton CP
通讯作者：
Denton CP
影响因子：
76.2
作者：
Crestani, Bruno;Huggins, John T.;Kreuter, Michael
通讯作者：
Kreuter, Michael
影响因子：
8.3
作者：
Paterniti, Miya O.;Bi, Youwei;Chowdhury, Badrul A.
通讯作者：
Chowdhury, Badrul A.