Real-world Outcomes and Tolerability of Nintedanib in Patients With Systemic Autoimmune Rheumatic Disease-associated...

Nintedanib, a tyrosine kinase inhibitor with antifibrotic properties, has been shown to significantly slow the progression of pulmonary fibrosis. The aim of this study is to assess the clinical characteristics, longitudinal pulmonary function tests, serial high-resolution computed tomography (HRCT) findings, and the efficacy, tolerability, and outcomes of nintedanib treatment in patients with systemic autoimmune rheumatic disease-associated interstitial lung disease (SARD-ILD) within a Middle Eastern population.

This is a cohort study conducted between May 2015 and March 2024, all patients with SARD-ILD treated with nintedanib were analyzed. Demographic and clinical data were collected before the initiation of nintedanib. Serial changes in percentage predicted forced vital capacity (ppFVC) and percentage predicted diffusing capacity for carbon monoxide (ppDLCO), as well as HRCT findings, were recorded at 6, 12, and 24 months posttreatment initiation. Adverse events of nintedanib were documented. Descriptive statistics were employed for data analysis.

A total of 47 patients with SARD-ILD received nintedanib. The most common diagnoses were systemic sclerosis (36.2%) and rheumatoid arthritis (17%). Over 24 months, patients showed stable or slightly improved ppFVC and ppDLCO values, and 89% had stable ILD on HRCT. Gastrointestinal adverse events were reported in 27.7% of patients. Five patients (10.6%) underwent lung transplantation, with an average time of 3.2 ± 2.2 years from treatment initiation to transplantation.

Our findings indicate that nintedanib is well-tolerated, with no new safety concerns identified. In addition, we observed clinically meaningful improvements in pulmonary function tests by 6 months, which were sustained through 24 months.