PMID- 37357024 OWN - NLM STAT- MEDLINE DCOM- 20231130 LR - 20240218 IS - 2151-4658 (Electronic) IS - 2151-464X (Print) IS - 2151-464X (Linking) VI - 75 IP - 12 DP - 2023 Dec TI - Risk of Malnutrition in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo-Controlled SENSCIS Trial. PG - 2501-2507 LID - 10.1002/acr.25176 [doi] AB - OBJECTIVE: To assess adverse events (AEs) 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 AEs in subgroups by baseline BMI 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 AE profile of nintedanib was similar between subgroups with a baseline BMI 20 kg/m(2) (n = 515). 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. 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. 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-ILD. CI - (c) 2023 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology. FAU - Volkmann, Elizabeth R AU - Volkmann ER AUID- ORCID: 0000-0003-3750-6569 AD - University of California, David Geffen School of Medicine, Los Angeles. FAU - McMahan, Zsuzsanna H AU - McMahan ZH AUID- ORCID: 0000-0001-6461-8940 AD - Johns Hopkins University, Baltimore, Maryland. FAU - Smith, Vanessa AU - Smith V AD - Ghent University Hospital, Ghent University, and VIB Inflammation Research Center, Ghent, Belgium. FAU - Jouneau, Stephane AU - Jouneau S AD - Competences Centre for Rare Pulmonary Diseases, and Univ Rennes, CHU Rennes, Inserm, EHESP, IRSET, Rennes, France. FAU - Miede, Corinna AU - Miede C AD - mainanalytics GmbH, Sulzbach (Taunus), Germany. FAU - Alves, Margarida AU - Alves M AD - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. FAU - Herrick, Ariane L AU - Herrick AL AUID- ORCID: 0000-0003-4941-7926 AD - The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, UK. CN - SENSCIS Trial Investigators LA - eng SI - ClinicalTrials.gov/NCT02597933 GR - K23 HL150237/HL/NHLBI NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230807 PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - G6HRD2P839 (nintedanib) RN - 0 (Indoles) SB - IM MH - Humans MH - *Lung Diseases, Interstitial/diagnosis/drug therapy/etiology MH - *Scleroderma, Systemic/complications/drug therapy MH - Indoles/adverse effects MH - *Malnutrition/diagnosis/drug therapy/etiology MH - Disease Progression MH - Vital Capacity PMC - PMC10749375 MID - NIHMS1915143 COIS- Conflict of interest: Elizabeth R. Volkmann reports grants paid to her institution from Boehringer Ingelheim (BI), Forbius, Horizon, Kadmon, the National Heart, Lung, and Blood Institute, and Prometheus; consulting fees from BI, GlaxoSmithKline, Roche; and fees for speaking from BI. Zsuzsanna H. McMahan reports grants from the Jerome L. Greene Foundation, National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, and Scleroderma Research Foundation; consulting fees from Triangle Insights Group; fees for speaking from Medscape; support for accommodation and meeting registration for the American College of Rheumatology (ACR) annual meeting as an AMPC Clinical Chair; and is the Chair of Finance for the ACR (unpaid). Vanessa Smith reports grants paid to her institution from the Belgian Fund for Scientific Research in Rheumatic Diseases, BI, Janssen-Cilag; payment to her institution for her role as a senior clinical investigator of the Research Foundation-Flanders (Belgium) (FWO) [1.8.029.20N]; consulting fees from BI and Janssen-Cilag; fees for speaking from BI, Galapagos, Janssen-Cilag; support for travel to the ACR congress from BI; and holds unpaid leadership or fiduciary roles with the ACR, EULAR, ERN-ReCONNET, and SCTC. Stephane Jouneau reports grants from AIRB, BI, LVL, Novartis, Roche; fees for speaking from AIRB, AstraZeneca, BI, Bristol Myers Squibb, Chiesi, Genzyme, GlaxoSmithKline, LVL, Novartis, Pfizer, Roche, Sanofi; support for attending meetings from AIRB, BI, Roche; and has participated on a Data Safety Monitoring Board or advisory board for BI, Novartis, Roche. Corinna Miede is an employee of mainanalytics GmbH, Sulzbach (Taunus), Germany, which was contracted by BI to assist with these analyses. Margarida Alves is an employee of BI. Ariane L. Herrick reports grants from Gesynta; consulting fees from Arena, BI, Camurus, CSL Behring, Gesynta, Galderma; and fees for speaking from Janssen. EDAT- 2023/06/26 00:41 MHDA- 2023/11/30 06:43 PMCR- 2024/12/01 CRDT- 2023/06/25 21:52 PHST- 2023/05/31 00:00 [revised] PHST- 2023/02/23 00:00 [received] PHST- 2023/06/20 00:00 [accepted] PHST- 2024/12/01 00:00 [pmc-release] PHST- 2023/11/30 06:43 [medline] PHST- 2023/06/26 00:41 [pubmed] PHST- 2023/06/25 21:52 [entrez] AID - 10.1002/acr.25176 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2023 Dec;75(12):2501-2507. doi: 10.1002/acr.25176. Epub 2023 Aug 7.