Systemic sclerosis & Raynaud's

Risk of Malnutrition in Patients With Systemic Sclerosis‐Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo‐Controlled SENSCIS Trial

Arthritis Care Res (Hoboken)Published Secondary analysis of the SENSCIS randomised trial

Authors' 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 who received treatment with nintedanib compared to those who received placebo.

Study context

Population
Patients with SSc-ILD randomised in the SENSCIS trial, subgroups by baseline body mass index (BMI) ≤20 kg/m² and >20 kg/m²subgroups by baseline BMI ≤20 kg/m² 61 · >20 kg/m² 515
Comparison
Nintedanib vs placebo
Primary endpoint
Adverse events (AEs) by baseline BMI subgroup and risk of malnutrition (modified Malnutrition Universal Screening Tool (MUST))
Follow-up
52 weeks
Methodological detailsplacebo-controlled, subgroup analysis by baseline BMI
  • Placebo-controlled
  • Subgroup analysis by baseline BMI

Primary result

As reported in the abstract

AEs leading to treatment discontinuation, by baseline BMI subgroup

BMI ≤20 kg/m²

BMI >20 kg/m²

Further findings

Low risk of malnutrition (modified MUST) at baseline and at last assessment · 52 weeks

Low risk of malnutrition at baseline but high risk by last assessment (modified MUST) · 52 weeks

Original publication

Risk of Malnutrition in Patients With Systemic Sclerosis‐Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo‐Controlled SENSCIS Trial. Arthritis Care Res (Hoboken). Published 7 August 2023. doi:10.1002/acr.25176

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