Safety and tolerability of nintedanib in patients with systemic sclerosis- associated interstitial lung disease: Data from the SENSCIS trial
Annals of Rheumatic Diseases Oct 19, 2020
Seibold JR, Maher TM, Highland KB, et al. - This study was sought to define the safety and tolerability of nintedanib and the dose adjustments applied to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The SENSCIS trial randomized SSc-ILD patients to receive nintedanib 150 mg two times per day or placebo. Treatment could be interrupted or the dose reduced to 100 mg two times per day to manage adverse events. Adverse events and dose adjustments were evaluated over 52 weeks. The study included a sum of 576 patients who received nintedanib (n=288) or placebo (n=288). The data revealed that in patients with SSc-ILD, the adverse event profile of nintedanib is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. The results exhibited that dose adjustment is important to minimize the effect of adverse events and help individuals remain on therapy.
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