Risk of malnutrition in patients with systemic sclerosis-associated interstitial lung disease treated with nintedanib

OBJECTIVE: To assess adverse events in relation to baseline body mass index (BMI) and the risk of malnutrition in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) treated with nintedanib. METHODS: Among patients with SSc-ILD randomized to receive nintedanib or placebo in the SENSCIS trial, we assessed adverse events in subgroups by baseline BMI ≤20 and >20 kg/m(2) , and the risk of malnutrition using a modified version of the Malnutrition Universal Screening Tool (MUST), over 52 weeks. RESULTS: The adverse event profile of nintedanib was similar between subgroups with baseline BMI ≤20 kg/m(2) (n=61) and >20 kg/m(2) (n=515). In these subgroups, respectively, adverse events led to treatment discontinuation in 16.7% and 15.9% of the nintedanib group and 13.5% and 8.0% of the placebo group. Based on the modified MUST, the proportions of patients who had a low risk of malnutrition at baseline and at their last assessment were 74.0% in the nintedanib group and 78.1% in the placebo group, while the proportions who were classified as at low risk at baseline but at high risk by their last assessment were 4.5% in the nintedanib group and 1.0% in the placebo group. CONCLUSION: In the SENSCIS trial, most patients with SSc-ILD remained at low risk of malnutrition over 52 weeks, but the proportion at high risk was higher in patients treated with nintedanib than placebo. Management of disease manifestations and adverse events that may be associated with weight loss is important to reduce the risk of malnutrition in patients with SSc-ILD.