Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease.
Oliver DistlerKristin B HighlandMartina GahlemannArata AzumaAryeh FischerMaureen D MayesGanesh RaghuWiebke SauterMannaig GirardMargarida AlvesEmmanuelle Clerisme-BeatySusanne StowasserKay TetzlaffMasataka KuwanaToby M Mahernull nullPublished in: The New England journal of medicine (2019)
Among patients with ILD associated with systemic sclerosis, the annual rate of decline in FVC was lower with nintedanib than with placebo; no clinical benefit of nintedanib was observed for other manifestations of systemic sclerosis. The adverse-event profile of nintedanib observed in this trial was similar to that observed in patients with idiopathic pulmonary fibrosis; gastrointestinal adverse events, including diarrhea, were more common with nintedanib than with placebo. (Funded by Boehringer Ingelheim; SENSCIS ClinicalTrials.gov number, NCT02597933.).