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Rituximab and mycophenolate mofetil in interstitial lung disease (EVER-ILD): 1-year follow-up results of a randomised controlled trial
European Respiratory Journal ( IF 16.6 ) Pub Date : 2024-09-12 , DOI: 10.1183/13993003.01368-2024
Laurène Mansy 1 , Agnès Caille 1, 2 , Martine Reynaud-Gaubert 3, 4 , Julien Bermudez 3, 4 , Philippe Bonniaud 5 , Raphael Borie 6, 7 , Pierre-Yves Brillet 8 , Jacques Cadranel 9 , Isabelle Court-Fortune 10 , Bruno Crestani 6, 7 , Marie-Pierre Debray 11, 12 , Mathilde Duprez 13 , Anne Guillaumot 14 , Sandrine Hirschi-Santelmo 15 , Dominique Israel-Biet 16 , Stéphane Jouneau 17, 18 , Karine Juvin 16 , Mallorie Kerjouan 17 , Julie Mankikian 19 , Charles-Hugo Marquette 20 , Jean-Marc Naccache 9, 21 , Hilario Nunes 22 , Laurent Plantier 19, 23 , Grégoire Prevot 24 , Sébastien Quetant 25 , Julie Traclet 26 , Victor Valentin 27 , Yurdagul Uzunhan 22 , Lidwine Wémeau-Stervinou 27 , Vincent Cottin 26 , Sylvain Marchand-Adam 23, 28 ,
Affiliation  

Extract

The nonspecific interstitial pneumonia (NSIP) pattern is a usual feature of interstitial lung disease (ILD) associated with connective tissue diseases (CTDs) [1], idiopathic interstitial pneumonia with autoimmune features (IPAF) [2] and several idiopathic ILDs (iILDs) [3]. The EVER-ILD trial randomised 126 patients between rituximab (1000 mg, on day 1 and day 15; n=65) versus placebo (n=61), in addition to mycophenolate mofetil (MMF) (2 g daily) for 6 months, in patients with NSIP pattern associated with CTD-ILD or idiopathic interstitial pneumonia (with or without autoimmune features) [4]. A primary analysis after 6 months of treatment showed a significant benefit of the rituximab+MMF combination on forced vital capacity (FVC) % predicted variation from baseline to 6 months (group*month interaction 3.60, 95% CI 0.41–6.80; p=0.03) and on progression-free survival (PFS) (crude HR 0.47, 95% CI 0.23–0.96; p=0.03).



中文翻译:


利妥昔单抗和吗替麦考酚酯治疗间质性肺疾病 (EVER-ILD):随机对照试验的 1 年随访结果


 提炼


非特异性间质性肺炎 (NSIP) 模式是与结缔组织病 (CTD) [1] 相关的间质性肺病 (ILD)、具有自身免疫特征的特发性间质性肺炎 (IPAF) [2] 和几种特发性 ILD (iILD) 的常见特征[3]。 EVER-ILD 试验将 126 名患者随机分为利妥昔单抗(1000 mg,第 1 天和第 15 天;n=65)安慰剂(n=61),此外还接受吗替麦考酚酯 (MMF)(每天 2 g)治疗 6 个月,与 CTD-ILD 或特发性间质性肺炎(有或没有自身免疫特征)相关的 NSIP 模式患者 [4]。治疗 6 个月后的初步分析显示,利妥昔单抗 + MMF 组合对用力肺活量 (FVC) 从基线到 6 个月的预测变化百分比具有显着益处(组*月交互作用 3.60,95% CI 0.41–6.80;p=0.03 )和无进展生存期 (PFS)(粗 HR 0.47,95% CI 0.23–0.96;p=0.03)。

更新日期:2024-09-12
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