HealthDay News — For patients with progressive fibrosing autoimmune disease-related interstitial lung diseases (ILDs), nintedanib slows the rate of decline in forced vital capacity (FVC) compared with placebo, according to a study published online Feb. 24 in Arthritis & Rheumatology.
Eric L. Matteson, M.D., M.P.H., from the Mayo Clinic College of Medicine and Science in Rochester, Minnesota, and colleagues examined the efficacy and safety of nintedanib in patients with fibrosing autoimmune disease-related ILDs. Despite management deemed appropriate in clinical practice, individuals fulfilled protocol-defined criteria for progression of ILD within the 24 months before screening. Data were analyzed for the subgroup of 170 individuals with autoimmune disease-related ILDs who were randomly assigned to either nintedanib or placebo.
The researchers found that the rate of decline in FVC over 52 weeks was −75.9 and −178.6 mL/year with nintedanib and placebo, respectively. There was no heterogeneity noted in the effect of nintedanib versus placebo for subgroups by ILD diagnosis. Diarrhea was the most frequent adverse event, reported in 63.4 and 27.3 percent in the nintedanib and placebo groups, respectively. In 17.1 and 10.2 percent of those in the nintedanib and placebo groups, respectively, adverse events led to permanent discontinuation of the trial drug.
“Until now, therapies that can significantly reduce the rate of decline in lung function in connective tissue disease-related ILDs characterized by progressive fibrosis have been lacking,” Matteson said in a statement. “We now have a therapeutic approach that offers a strategy for reducing the morbidity associated with these diseases.”
Several authors disclosed financial ties to biopharmaceutical companies, including Boehringer Ingelheim, which manufactures nintedanib and funded the trial.