Patients receiving nintedanib for SSc-ILD at increased risk for malnutrition vs placebo
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Key takeaways:
- The rate of malnutrition in the study population was generally low.
- Rheumatologists should consider patients’ risk for malnutrition when treating SSc.
Patients with systemic sclerosis-associated interstitial lung disease who receive nintedanib demonstrate a higher risk for malnutrition, compared with placebo, according to data published in Arthritis Care & Research.
“The majority of patients with systemic sclerosis experience gastrointestinal tract symptoms, and for some patients this can lead to malnutrition, weight loss and death in severe cases,” Elizabeth R. Volkmann, MD, MS, of the David Geffen School of Medicine at the University of California Los Angeles, told Healio. “Nintedanib is a new medication for systemic sclerosis-related interstitial lung disease (SSc-ILD), and many patients who take nintedanib develop diarrhea as a side effect.”
“The purpose of this study was to determine whether the use of nintedanib was associated with an increased risk for malnutrition in patients with SSc-ILD participating in the SENSCIS trial,” she added.
To investigate the relationship between nintedanib (Ofev, Boehringer Ingelheim) use for SSc-ILD and the risk for malnutrition, Volkmann and colleagues analyzed data from the SENSCIS trial of patients diagnosed with SSc who had their first non-Raynaud’s syndrome symptom within the last 7 years. Included patients demonstrated 10% or greater involvement of fibrotic ILD, a forced vital capacity of 40% or more, and diffusing capacity of the lungs between 30% to 89%. Participants were randomized 1:1 to receive either nintedanib 150 mg twice each day or a placebo for 52 weeks.
The researchers employed a modified Malnutrition Universal Screening Tool (MUST) throughout the study period. Scores of 0, 1 and 2 indicated low, medium and high risks of malnutrition, respectively. The researchers additionally analyzed adverse event reports relating to patients with low and high baseline BMI scores. The low BMI group included 61 patients, while the standard BMI group included 515 patients.
According to the researchers, adverse events were similar across subgroups of patients with baseline BMI scores of either 20 kg/m2 or less, or greater than 20 kg/m2. Among patients receiving nintedanib, the low BMI group demonstrated a therapy discontinuation rate of 16.7%, while the standard BMI group had a discontinuation rate of 15.9%. Discontinuation rates in the placebo group, meanwhile, were 13.5% in the low BMI group and 8% in the standard BMI group.
While accounting for MUST scores, the rate of patients identified as low risk for malnutrition at baseline, but at high risk at follow up, was 4.5% in the nintedanib group, and 1% in the placebo group.
“The risk for malnutrition was low in this cohort and remained low throughout the duration of the trial,” Volkmann said. “However, the proportion of patients at high risk of malnutrition was higher in the nintedanib arm, compared with the placebo arm. Rheumatologists should consider their patient's risk of malnutrition when selecting therapy for systemic sclerosis.”
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