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4CPS-314 Real-world effectiveness, safety, and adherence of nintedanib in a tertiary care hospital

ejhpharm · 2026-03-18 · canonical JSON source

13 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Diffuse interstitial lung diseases (DILD), including idiopathic pulmonary fibrosis (IPF) and progressive fibrosing lung disease (PFLD), may evolve into a fibrotic phenotype with functional decline. Antifibrotic therapy, particularly nintedanib, has significantly improved management by slowing forced vital capacity (FVC) decline.Aim and Objectives To evaluate efficacy, safety, and adherence with nintedanib in patients with pulmonary fibrosing disease in a tertiary hospital.Material and Methods Observational, retrospective, single-centre study. Patients who started nintedanib between January 2020 and March 2025 were included. Variables: age, sex, diagnosis, prescribing service, duration of treatment and FVC, DLCO, and walking test at baseline, 6 and 12 months; adherence (considering adherent patients if possession rate was ≥90%), dose reduction or withdrawal, concomitant medication, and hospital admissions. Information was obtained from pharmacy dispensing records and Electronic Health Records.Results Thirty-three patients were included, 21 (63.6%) male, with a mean age of 69±15 years. Sixteen patients (48.5%) had IPF, 15 (45.5%) PFLD, and two (6%) interstitial lung disease secondary to scleroderma.Prescribing departments were Pneumology (67%), Rheumatology (18%), and Internal Medicine (15%).The mean treatment duration was 636±487 days.FVC remained stable at 6 months in 48.5% of patients, 18.2% worsened, and 33.3% were non-assessable. At 12 months, 36.4% were stable, 21.2% worsened, and 42.4% were non-assessable.By diagnosis, stable FVC was observed in 27.3%, 21.2%, and 18.2% of IPF patients at baseline, 6, and 12 months, compared with 18.2%, 12.1%, and 15.1% in PFLD.DLCO decreased ≥3 points in 51.5% patients, improved ≥3 points in 15.1%, showed no change in 18.2% and 15.2% had missing data at 6 and 12 months. The walking test was stable, though data were unavailable in 48.5% and 60% of the patients at 6 and 12 months.Adherent patients were 87%. Treatment discontinuation occurred in 36%: death (18%), diarrhoea (15%), and due to lung transplantation (3%). Dose reduction was required in 33%.Concomitant therapy included prior mycophenolate in 18% and ≥5 drugs in 73%. Hospitalisations occurred in 45%.Conclusion and Relevance Nintedanib slows progression of pulmonary fibrosis, promoting clinical stability. Diarrhoea was the most significant adverse effect, leading to dose reductions or discontinuation. Advanced age, polymedication (73% of patients), and clinical vulnerability reinforce the need for close monitoring by hospital pharmacies.Conflict of Interest No conflict of interest