Conclusions

In the SENSCIS trial in subjects with SSc-ILD, the effect of nintedanib on reducing the rate of FVC decline was consistent between subgroups by baseline BMI <25 and ≥25 kg/m².
The adverse event profile of nintedanib was similar between subgroups by BMI <25 and ≥25 kg/m². In both the nintedanib and placebo groups, adverse events leading to discontinuation of trial drug were more common in patients with BMI <25 than >25 kg/m² at baseline.
Weight loss was reported more frequently as an adverse event, but did not lead to a higher frequency of treatment discontinuation, in subjects with BMI <25 compared to >25 kg/m² at baseline.