Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease (SENSCIS)

Systemic sclerosis–associated ILD (SSc-ILD) is a leading cause of death in scleroderma. Prior treatments included cyclophosphamide (modest benefit) and mycophenolate. SENSCIS tested nintedanib specifically in SSc-ILD.

Multicenter RCT (n=576) comparing nintedanib 150 mg BID vs. placebo in SSc-ILD over 52 weeks.

Nintedanib reduced annual FVC decline (−52.4 vs −93.3 ml/year, p=0.04). Benefit was consistent regardless of background mycophenolate use. Diarrhea occurred in 76% of nintedanib patients.

Nintedanib is FDA-approved for SSc-ILD. It can be used with or without background mycophenolate. Diarrhea management is critical — loperamide, dose reduction, or temporary interruption are strategies.

No mortality benefit demonstrated. High diarrhea rate. Mycophenolate was not randomized.