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.
The key findings of this study were;
1. There were 197 patients in the continuing nintedanib group and 247 individuals in the starting nintedanib group.
2. Mean FVC at the commencement of SENSCIS-ON was 2379 mL and 70.4 (18.1)% predicted in these groups, and 2443 (814) mL and 70.8 (17.9)% anticipated in the other.
3. At week 148 of SENSCIS-ON, 126 (64.0%) and 125 (50.6%) patients in the continuing nintedanib and began nintedanib groups, respectively, were still receiving nintedanib.
4. The most common adverse effect was diarrhea. Serious adverse events were recorded in 76 (38.6%) of the continuing nintedanib patients and 95 (38.5%) of the starting nintedanib patients.
5. Among patients who maintained nintedanib and those who started it, 53 (26.9%) and 148 (59.9%) had one dosage decrease and 72 (36.5%) and 131 (53.0%) had one treatment interruption, respectively.
6. Adverse events resulted to nintedanib cessation in 29 (14.7%) of the continuing nintedanib group and 72 (29.1%) of the begun nintedanib group.
7. From baseline to week 148 of SENSCIS-ON, mean (SE) changes in FVC were 189.1 (29.5) mL in the continuing nintedanib group and 126.4 (26.4) mL in the started nintedanib group.
Reference:
Allanore Y, Vonk M, Distler O, Azuma A, Mayes M, James A, Kohlbrenner V, Alves M, Khanna D, Highland K. Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Three-Year Data from SENSCIS-ON [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).
