Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease

Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease

May 20, 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 Clerisse-Beaty, M.D., Susanne Stowasser, M.D., Kay Tetzlaff, M.D., Masataka Kuwana, M.D., and Toby M. Maher, M.D., for the SENSCIS Trial Investigators*
The SENS CIS trial investigated 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, who were randomly assigned to receive either nintedanib (150 mg twice daily) or a placebo. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks, with a secondary endpoint being changes in the modified Rodnan skin score and the St. George's Respiratory Questionnaire (SGRQ) total score at week 52. The adjusted annual rate of decline in FVC was significantly lower in the nintedanib group compared to the placebo group (−52.4 ml/year vs. −93.3 ml/year; P=0.04). However, no significant differences were observed in the modified Rodnan skin score or the SGRQ total score between the two groups. The most common adverse event was diarrhea, occurring in 75.7% of the nintedanib group and 31.6% of the placebo group. 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 found that nintedanib reduced the rate of decline in FVC in patients with ILD associated with systemic sclerosis, but no clinical benefit was observed for other manifestations of systemic sclerosis. The results suggest that nintedanib may be effective in slowing the progression of ILD in systemic sclerosis, but it does not address other organ complications. The safety profile of nintedanib was similar to that observed in the INPULSIS trials, with gastrointestinal adverse events being more common in patients with systemic sclerosis-associated ILD. Despite the large variability in the adjusted annual rates of decline in FVC, the data suggest a potential benefit of mycophenolate on lung function. The study highlights the importance of further research to determine the long-term effects of nintedanib in patients with ILD associated with systemic sclerosis.The SENS CIS trial investigated 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, who were randomly assigned to receive either nintedanib (150 mg twice daily) or a placebo. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks, with a secondary endpoint being changes in the modified Rodnan skin score and the St. George's Respiratory Questionnaire (SGRQ) total score at week 52. The adjusted annual rate of decline in FVC was significantly lower in the nintedanib group compared to the placebo group (−52.4 ml/year vs. −93.3 ml/year; P=0.04). However, no significant differences were observed in the modified Rodnan skin score or the SGRQ total score between the two groups. The most common adverse event was diarrhea, occurring in 75.7% of the nintedanib group and 31.6% of the placebo group. 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 found that nintedanib reduced the rate of decline in FVC in patients with ILD associated with systemic sclerosis, but no clinical benefit was observed for other manifestations of systemic sclerosis. The results suggest that nintedanib may be effective in slowing the progression of ILD in systemic sclerosis, but it does not address other organ complications. The safety profile of nintedanib was similar to that observed in the INPULSIS trials, with gastrointestinal adverse events being more common in patients with systemic sclerosis-associated ILD. Despite the large variability in the adjusted annual rates of decline in FVC, the data suggest a potential benefit of mycophenolate on lung function. The study highlights the importance of further research to determine the long-term effects of nintedanib in patients with ILD associated with systemic sclerosis.
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