{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T17:53:48Z","timestamp":1790013228152,"version":"4.0.1"},"reference-count":42,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T00:00:00Z","timestamp":1691366400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis Care & Research"],"published-print":{"date-parts":[[2023,12]]},"abstract":"Objective<\/jats:title>To assess adverse events (AEs) in relation to baseline body mass index (BMI) and the risk of malnutrition in patients with systemic sclerosis\u2013associated interstitial lung disease (SSc\u2013ILD) treated with nintedanib.<\/jats:p><\/jats:sec>Methods<\/jats:title>Among patients with SSc\u2013ILD randomized to receive nintedanib or placebo in the SENSCIS trial, we assessed AEs in subgroups by baseline BMI \u226420 kg\/m2<\/jats:sup> and BMI >20 kg\/m2<\/jats:sup>, and the risk of malnutrition using a modified version of the Malnutrition Universal Screening Tool (MUST), over 52\u2009weeks.<\/jats:p><\/jats:sec>Results<\/jats:title>The AE profile of nintedanib was similar between subgroups with a baseline BMI \u226420 kg\/m2<\/jats:sup> (n\u00a0=\u00a061) and a baseline BMI >20 kg\/m2<\/jats:sup> (n\u00a0=\u00a0515). In these subgroups, respectively, AEs led to treatment discontinuation in 16.7% and 15.9% of the nintedanib group and 13.5% and 8.0% of the placebo group, respectively. 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.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>In the SENSCIS trial, most patients with SSc\u2013ILD remained at low risk of malnutrition over 52\u2009weeks, but the proportion at high risk was higher in patients who received treatment with nintedanib compared to those who received placebo. Management of disease manifestations and AEs that may be associated with weight loss is important to reduce the risk of malnutrition in patients with SSc\u2013ILD.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.25176","type":"journal-article","created":{"date-parts":[[2023,6,25]],"date-time":"2023-06-25T21:42:56Z","timestamp":1687729376000},"page":"2501-2507","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Risk of Malnutrition in Patients With Systemic Sclerosis\u2010Associated<\/scp> Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo\u2010Controlled<\/scp> SENSCIS Trial"],"prefix":"10.1002","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3750-6569","authenticated-orcid":false,"given":"Elizabeth R.","family":"Volkmann","sequence":"first","affiliation":[{"name":"University of California, David Geffen School of Medicine Los 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