Clinical Significance of Sustained Nintedanib Treatment in Idiopathic Pulmonary Fibrosis: A 12-Month Real-World Evaluation

Evidence from clinical trials such as INPULSIS-ON indicates that extended use of nintedanib is generally safe for patients with idiopathic pulmonary fibrosis (IPF). Nevertheless, real-world data on long-term therapy are scarce. This study examined how effective and tolerable prolonged nintedanib treatment is when used in everyday clinical care. This retrospective review included 104 individuals diagnosed with IPF who received nintedanib. Patients were divided into two cohorts: those who maintained therapy for more than 12 months (P group, n=51) and those who discontinued before reaching 12 months (I group, n=53). Clinical outcomes and treatment tolerance were evaluated across both groups. In the I group, 29 patients halted treatment because of adverse reactions—most commonly diarrhea and nausea or poor appetite. Another 19 discontinued due to disease progression, and 4 because their performance status (PS) worsened. One patient died unexpectedly during therapy. Nausea/anorexia occurred almost twice as often in the I group compared with the P group (49.06% vs 25.49%). Patients who continued therapy beyond 12 months lived significantly longer (median 35 vs 12 months) and showed a markedly smaller annual reduction in forced vital capacity (10 mL/year vs 165 mL/year). A poor PS at treatment start was the only factor strongly associated with failing to maintain therapy beyond 12 months. Patients with better initial PS also demonstrated superior survival (27 vs 13 months). Reduced baseline PS markedly increases the likelihood of discontinuing nintedanib within the first year. Maintaining long-term therapy appears to offer a survival advantage for individuals with IPF.