Nintedanib in Severe Idiopathic Pulmonary Fibrosis: Effectiveness through Compassion

Tzouvelekis, Argyrios; Bouros, Demosthenes

doi:10.1159/000488647

Cited by 3 publications

(1 citation statement)

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“…Although randomised controlled trials are initially necessary to characterise the efficacy and safety profile of a given drug, a fuller picture of that drug's effectiveness can be gained through real-world studies. One useful source of real-world data is registries, several of which have been established for IPF [8][9][10][11][12][13][14], and a growing number of real-world clinical experiences with nintedanib in IPF have now been published [15][16][17][18][19][20][21]. In the present study, we report data from the largest IPF registry in Greece to date, covering 244 patients treated with nintedanib for ⩾3 years at referral respiratory departments across seven hospitals.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of nintedanib in a Greek multicentre idiopathic pulmonary fibrosis registry: a retrospective, observational, cohort study

et al. 2020

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Nintedanib is a tyrosine kinase inhibitor approved for the treatment of idiopathic pulmonary fibrosis (IPF). In a retrospective, real-world study across seven Greek hospitals, we evaluated the effectiveness and safety of nintedanib in routine clinical practice. Patients diagnosed with IPF, as per guideline criteria or multidisciplinary diagnosis, received nintedanib between January 2013 and January 2018.We evaluated 244 patients: mean±sd age 71.8±7.5 years, 79.1% male, 45.1% current smokers and 33.1% ex-smokers at treatment initiation. At baseline, predicted forced vital capacity (FVC) was 73.3±20.7% and predicted diffusing capacity of the lungs for carbon monoxide (DLCO) was 42.6±16.7%. On average, patients spent 23.6±15.0 months on nintedanib. At 3 years, 78 patients had died, equating to a 3-year survival rate of 59.4% (unaffected by treatment discontinuation or dose reduction). FVC% pred and DLCO% pred were largely stable at 3 years, with no significant difference from baseline (FVC 73.3±20.7% pred versus 78±20.1% pred, p=0.074; DLCO 42.6±16.7% pred versus 40.4±18.1% pred, p=0.334). Of the 244 patients, 55.7% reported an adverse event. Gastrointestinal events were the most common (173 (77.2%) out of 224 total events) and 45.0% of patients experienced diarrhoea. Only 32 (13.1%) patients had to permanently discontinue nintedanib due to an adverse event.This real-world study shows a 3-year survival rate of 59.4% and a low discontinuation rate due to adverse events. Our experience is consistent with previous findings in clinical trials of nintedanib in IPF.

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