Nintedanib has consistent safety profile against Systemic Sclerosis-Associated Interstitial Lung Disease

A new study presented at American College of Rheumatology suggests that over 148 weeks of SENSCIS-ON, the safety profile of nintedanib was consistent with that described in the SENSCIS study, characterized mostly by gastrointestinal problems that were controllable for the majority of patients.

In the randomized placebo-controlled SENSCIS study, nintedanib lowered the rate of decline in forced vital capacity (FVC) (mL/year) by 44% over 52 weeks in patients with Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), with most patients experiencing tolerable side effects. SENSCIS-ON is an open-label extension trial looking at long-term adverse events and FVC decrease in patients with SSc-ILD treated with nintedanib.

Patients in the SENSCIS study received nintedanib or placebo until the final patient reached week 52, but for a total of 100 weeks. Patients with SSc-ILD who completed the SENSCIS trial or a drug-drug interaction (DDI) study of nintedanib and oral contraceptive in which female SSc-ILD patients received nintedanib for 14 to 28 days were eligible to participate in SENSCIS-ON. Over 148 weeks, we looked at adverse events and changes in FVC in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON ("continued nintedanib" group) and patients who received placebo in SENSCIS or nintedanib for 28 days in the DDI study ("initiated nintedanib" group). The analyses were descriptive in nature. FVC analyses were based on observable data available at the time-point in question.