Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

June 27, 2019 | Oliver Distler, M.D., Kristin B. Highland, M.D., Martina Gahlemann, M.D., Arata Azuma, M.D., Aryeh Fischer, M.D., Maureen D. Mayes, M.D., Ganesh Raghu, M.D., Wiebke Sauter, Ph.D., Mannaig Girard, M.Sc., Margarida Alves, M.D., Emmanuelle Clerisme-Beaty, M.D., Susanne Stowasser, M.D., Kay Tetzlaff, M.D., Masataka Kuwana, M.D., and Toby M. Maher, M.D., for the SENCIS Trial Investigators
The SENSCIS trial evaluated the efficacy and safety of nintedanib in patients with interstitial lung disease (ILD) associated with systemic sclerosis. The study was a randomized, double-blind, placebo-controlled trial involving 576 patients with systemic sclerosis and ILD. Patients were randomly assigned to receive either nintedanib (150 mg twice daily) or placebo. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. Nintedanib was associated with a significantly lower annual decline in FVC compared to placebo (-52.4 ml/year vs. -93.3 ml/year; P=0.04). Secondary endpoints, including changes in the modified Rodnan skin score and the St. George's Respiratory Questionnaire (SGRQ) total score, did not show significant differences between the groups. The most common adverse event was diarrhea, occurring in 75.7% of nintedanib-treated patients and 31.6% of placebo-treated patients. Nintedanib did not show clinical benefit for other manifestations of systemic sclerosis. The adverse-event profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis, with gastrointestinal adverse events being more common. The trial was funded by Boehringer Ingelheim. The results suggest that nintedanib may reduce the decline in FVC in patients with ILD associated with systemic sclerosis, but it does not address other organ complications of the disease. The study highlights the importance of further research to determine the broader clinical benefits of nintedanib in systemic sclerosis.The SENSCIS trial evaluated the efficacy and safety of nintedanib in patients with interstitial lung disease (ILD) associated with systemic sclerosis. The study was a randomized, double-blind, placebo-controlled trial involving 576 patients with systemic sclerosis and ILD. Patients were randomly assigned to receive either nintedanib (150 mg twice daily) or placebo. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. Nintedanib was associated with a significantly lower annual decline in FVC compared to placebo (-52.4 ml/year vs. -93.3 ml/year; P=0.04). Secondary endpoints, including changes in the modified Rodnan skin score and the St. George's Respiratory Questionnaire (SGRQ) total score, did not show significant differences between the groups. The most common adverse event was diarrhea, occurring in 75.7% of nintedanib-treated patients and 31.6% of placebo-treated patients. Nintedanib did not show clinical benefit for other manifestations of systemic sclerosis. The adverse-event profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis, with gastrointestinal adverse events being more common. The trial was funded by Boehringer Ingelheim. The results suggest that nintedanib may reduce the decline in FVC in patients with ILD associated with systemic sclerosis, but it does not address other organ complications of the disease. The study highlights the importance of further research to determine the broader clinical benefits of nintedanib in systemic sclerosis.
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