Nintedanib, an intracellular inhibitor targeting multiple tyrosine kinases, has emerged as a standard treatment for various fibrotic lung diseases. Despite its efficacy, side effects such as nausea, diarrhea, and hepatotoxicity often lead to dose reduction or discontinuation. In this retrospective analysis at an university hospital's interstitial lung disease clinic, we aimed to identify baseline characteristics associated with dose adjustment or treatment discontinuation. Of the 58 patients included, 41.4% maintained the full nintedanib dose, while 31.0% required dosage reduction, and 27.6% discontinued treatment due to adverse events, predominantly gastrointestinal and hepatotoxic effects. Multivariate analysis revealed body surface area (BSA) as an independent and significant baseline risk factor (adjusted Odds Ratio [aOR] 0.22), suggesting a 78% decreased chance of requiring dose modification for every decimal point increase in BSA. A BSA cutoff of ≤1.73 m [2] exhibited a sensitivity of 73% and specificity of 91.7%, with significant impact on one-year survival under full-dose treatment (p < 0.001). Lower BSA was associated with early onset adverse effects, particularly gastrointestinal, supporting the need for regular clinical monitoring. The study emphasizes the importance of recognizing baseline factors to ensure the safety and tolerability of nintedanib, thereby preventing the progression of pulmonary fibrosis. These findings contribute to the evolving understanding of nintedanib management in fibrotic interstitial lung diseases, guiding clinicians in personalized treatment approaches.

中文翻译：

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纤维化间质性肺疾病中尼达尼布剂量减少和停药的预测因素：真实生活数据

尼达尼布是一种针对多种酪氨酸激酶的细胞内抑制剂，已成为各种纤维化肺部疾病的标准治疗方法。尽管其有效，但恶心、腹泻和肝毒性等副作用常常导致剂量减少或停药。在大学医院间质性肺病诊所的回顾性分析中，我们旨在确定与剂量调整或治疗停止相关的基线特征。在纳入的 58 名患者中，41.4% 的患者维持完整的尼达尼布剂量，31.0% 的患者需要减少剂量，27.6% 的患者因不良事件（主要是胃肠道和肝毒性作用）而停止治疗。多变量分析显示体表面积 (BSA) 是一个独立且显着的基线风险因素（调整后优势比 [aOR] 0.22），表明 BSA 每增加一个小数点，需要调整剂量的机会就会减少 78%。 BSA 截止值≤1.73 m [2] 的敏感性为 73%，特异性为 91.7%，对全剂量治疗下的一年生存率有显着影响 (p < 0.001)。较低的 BSA 与早期发生的不良反应（尤其是胃肠道反应）相关，这支持了定期临床监测的必要性。该研究强调了认识基线因素的重要性，以确保尼达尼布的安全性和耐受性，从而防止肺纤维化的进展。这些发现有助于加深对尼达尼布治疗纤维化间质性肺疾病治疗的理解，指导临床医生采取个性化治疗方法。