Purpose: The INPULSIS-ON study suggested the safety and tolerability of long-term nintedanib treatment for idiopathic pulmonary fibrosis (IPF). However, there are no real-world studies on long-term nintedanib treatment. The main aim of the study was to investigate the efficacy and the tolerability of long-term treatment with nintedanib for IPF in clinical practice.
Patients and Methods: This retrospective study enrolled 104 IPF patients who underwent treatment with nintedanib. Among these patients, 51 were able to receive nintedanib for more than 12 months (ie, treatment with nintedanib over 12 months was possible [P group]) and 53 were not able to receive nintedanib for more than 12 months (ie, treatment with nintedanib over 12 months was impossible [I group]). The tolerability and efficacy of nintedanib were compared between the two groups.
Results: In the I group, 29 patients were unable to continue nintedanib therapy because of adverse effects, including diarrhea and nausea/anorexia. In addition, 19 and four patients could not continue nintedanib treatment because of IPF progression and worsening of performance status (PS), respectively. One patient suddenly died during nintedanib treatment. The incidence of nausea/anorexia in the I group was significantly higher than in the P group (49.06 vs 25.49%). The survival time was significantly longer in the P group than in the I group (35 vs 12 months). The decline in forced vital capacity was significantly larger in the I group than in the P group (165 vs 10 mL/year). Poor PS at nintedanib initiation was the only significant risk factor for nintedanib treatment discontinuation over 12 months. Finally, the survival time was significantly longer in patients with good PS than in those with poor PS (27 vs 13 months).
Conclusion: Poor PS can result in discontinuation of nintedanib after 12 months. Long-term nintedanib treatment may be effective for survival.

Keywords: idiopathic pulmonary fibrosis, nintedanib, real-world setting, performance status, nausea


中文翻译：

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在真实环境中持续使用尼达尼布治疗特发性肺纤维化超过 12 个月的临床意义

目的： INPULSIS-ON 研究表明长期尼达尼布治疗特发性肺纤维化 (IPF) 的安全性和耐受性。然而，没有关于长期尼达尼布治疗的真实世界研究。该研究的主要目的是调查在临床实践中长期使用尼达尼布治疗 IPF 的疗效和耐受性。
患者和方法：这项回顾性研究招募了 104 名接受尼达尼布治疗的 IPF 患者。在这些患者中，51 人能够接受尼达尼布治疗超过 12 个月（即尼达尼布治疗可能超过 12 个月[P 组]），53 人不能接受尼达尼布治疗超过 12 个月（即尼达尼布治疗超过12个月是不可能的[我组]）。比较两组尼达尼布的耐受性和疗效。
结果：在 I 组中，29 名患者因不良反应（包括腹泻和恶心/厌食）而无法继续尼达尼布治疗。此外，分别有 19 名和 4 名患者因 IPF 进展和体能状态（PS）恶化而无法继续尼达尼布治疗。一名患者在尼达尼布治疗期间突然死亡。I组恶心/厌食症的发生率明显高于P组（49.06 vs 25.49%）。P 组的生存时间明显长于 I 组（35 个月 vs 12 个月）。I组用力肺活量的下降幅度明显大于P组（165 vs 10 mL/年）。尼达尼布开始时 PS 差是 12 个月内尼达尼布治疗中止的唯一显着风险因素。最后，
结论： PS差可导致12个月后停用尼达尼布。长期尼达尼布治疗可能对生存有效。

关键词：特发性肺纤维化，尼达尼布，真实环境，体能状态，恶心