While overall risk remained low, patients treated with long-term nintedanib for systemic sclerosis-associated interstitial lung disease (SSc-ILD) may be at higher risk for malnutrition, according to study findings published in Arthritis Care & Research.
Nintedanib, licensed for the treatment of SSc-ILD, has been linked to adverse gastrointestinal events. Although malnutrition has been associated with increased mortality, it is unclear whether this association is due to the direct influence of malnutrition or increased disease severity. Researchers aimed to evaluate the risk for malnutrition among patients with SSc-ILD treated with nintedanib vs placebo.
The researchers conducted a post-hoc analysis of the SENSCIS trial, in which patients were randomly assigned 1:1 to receive nintedanib 150 mg twice daily or placebo.
Weight was measured periodically, and a modified version of the Malnutrition Universal Screening Tool (MUST) was used to assess risk for malnutrition at weeks 12, 24, 36 and 52. The MUST scores ranged from 0 to 6, with researchers assigning scores of 0, 1, and 2 or higher to indicate a low, medium and high risk for malnutrition, respectively.
Researchers evaluated adverse events (AEs) according to mean MUST scores over a 52-week period, stratified by baseline body mass index (BMI; ≤20 and >20 kg/m2) between both groups.
A total of 576 patients were included in the analysis, of which 61 had a BMI ≤20 kg/m2 at baseline.
At baseline, comparable rates of AEs were noted between subgroups of BMI, with diarrhea being the most common AE reported (79.2% of patients with a BMI ≤20 kg/m2 vs 75.4% of patients with a BMI >20 kg/m2). Serious AEs were more frequently seen among patients with a BMI ≤20 kg/m2 (33.3%) vs >20 kg/m2 (23.1%).
Between weeks 12 and 52, the proportion of patients considered at low-risk for malnutrition based on MUST scores were comparable between the nintedanib and placebo groups. However, during the same time period, those considered at high-risk for malnutrition ranged from 5.6% to 9.6% in the nintedanib group and from 4.3% to 5.4% in the placebo group.
The proportion of patients who were considered at low-risk for malnutrition based on MUST scores at baseline and final measurement was slightly lower among the nintedanib group (74.0%) vs the placebo group (78.1%).
Notably, the proportion of patients considered at low-risk for malnutrition at baseline who were later considered at high-risk based on final measurements was greater among the nintedanib group (4.5%) vs the placebo group (1.0%).
Limitations of this analysis included its post-hoc nature and short follow-up period, which prevented long-term assessment of weight loss and malnutrition. Additionally, the MUST scores were not specifically designed to evaluate for malnutrition among patients with SSc. Finally, the number of patients with BMI <20 kg/m2 was small.
The study authors concluded, “Our findings illustrate the importance of monitoring for gastrointestinal problems, weight loss and malnutrition in patients with c who are treated with nintedanib and ensuring that patients receive nutritional counselling when needed.”
Disclosure: One or more of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Volkmann ER, McMahon ZH, Smith V, et al. Risk of malnutrition in patients with systemic sclerosis-associated interstitial lung disease treated with nintedanib. Arthritis Care Res (Hoboken). Published online June 25, 2023. doi:10.1002/acr.25176