Maggisano Marta, Mondini Lucrezia, Chernovsky Maria, Confalonieri Paola, Salton Francesco, Reccardini Nicolò, Kodric Metka, Geri Pietro, Confalonieri Marco, Hughes Michael, Cifaldi Rossella, Ruaro Barbara
Pulmonology Unit, Department of Medical Surgical and Health Sciences, University of Trieste, Hospital of Cattinara, 34149 Trieste, Italy.
Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester Salford Royal NHS Foundation Trust, Manchester M6 8HD, UK.
Pharmaceuticals (Basel). 2024 Aug 30;17(9):1147. doi: 10.3390/ph17091147.
Nintedanib, an intracellular inhibitor that targets multiple tyrosine kinase, is an important drug for the treatment of pulmonary fibrosis. Until now, no studies have been published reporting the nintedanib tolerability or its efficacy in patients with chronic pulmonary lung disease and chronic kidney disease comorbidity. The safety, efficacy and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (creatinine clearance < 30 mL/min) and for this reason it is contraindicated in these patients. We describe a case of use of nintedanib in a patient affected by idiopathic pulmonary fibrosis (IPF) who started, from 2022, nintedanib 150 mg twice a day with careful monitoring of liver and kidney function. Due to the onset of stage 3/4 chronic kidney disease associated with proteinuria, nintedanib was suspended for two months, and the patient received Prednisone at a dose of 12.5 mg/day. During the two months of suspension, the renal function did not improve, unlike the respiratory status worsened. In the past a renal biopsy was performed which showed no correlation with nintedanib use. Nintedanib therapy started again following the decline in lung function and desaturation below 90% in the 6-min walking test (6MWT). Patient showed a good tolerability of nintedanib with sporadic episode of diarrhea and an improvement of pulmonary function leading to a stable state of chronic pulmonary fibrosis disease. For this reason, in mutual agreement with the patient, we decided to maintain nintedanib therapy even when the patient required hemodialysis. No toxic effects appeared. This case report revealed the safety of nintedinab in patient with concomitant kidney failure, but more studies are necessary.
尼达尼布是一种靶向多种酪氨酸激酶的细胞内抑制剂,是治疗肺纤维化的重要药物。到目前为止,尚未发表关于尼达尼布在慢性肺病和慢性肾病合并症患者中的耐受性或疗效的研究。尼达尼布在严重肾功能损害(肌酐清除率<30 mL/分钟)患者中的安全性、疗效和药代动力学尚未得到研究,因此这些患者禁用。我们描述了一例特发性肺纤维化(IPF)患者使用尼达尼布的病例,该患者自2022年起开始每天两次服用150毫克尼达尼布,并仔细监测肝肾功能。由于出现了与蛋白尿相关的3/4期慢性肾病,尼达尼布停用了两个月,患者接受了每日12.5毫克的泼尼松治疗。在停药的两个月期间,肾功能没有改善,而呼吸状况恶化。过去进行了肾活检,结果显示与使用尼达尼布无关。在肺功能下降且6分钟步行试验(6MWT)中血氧饱和度低于90%后,再次开始尼达尼布治疗。患者对尼达尼布耐受性良好,偶有腹泻发作,肺功能有所改善,慢性肺纤维化疾病状态稳定。因此,经与患者共同商定,我们决定即使患者需要血液透析也维持尼达尼布治疗。未出现毒性作用。本病例报告揭示了尼达尼布在合并肾衰竭患者中的安全性,但仍需要更多研究。