{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T20:28:17Z","timestamp":1790368097495,"version":"4.1.0"},"reference-count":28,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,3,8]],"date-time":"2021-03-08T00:00:00Z","timestamp":1615161600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","award":["Boehringer Ingelheim"],"award-info":[{"award-number":["Boehringer Ingelheim"]}],"id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>In the SENSCIS trial in subjects with systemic sclerosis\u2013associated interstitial lung disease (SSc\u2010ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of \u22655% predicted or death and absolute decline in FVC of \u226510% predicted or death.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of &gt;5% to \u226410% predicted, and 3.5% and 5.2% had a decline in FVC of &gt;10% to \u226415% predicted; 34.5% and 43.8% had a decrease in FVC of \u22653.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of \u22653.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of \u22655% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66\u22121.06) (<jats:italic>P<\/jats:italic> = 0.14), and the HR for an absolute decline in FVC of \u226510% predicted was 0.64 (95% CI 0.43\u22120.95) (<jats:italic>P<\/jats:italic> = 0.029).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc\u2010ILD.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41576","type":"journal-article","created":{"date-parts":[[2020,11,3]],"date-time":"2020-11-03T13:29:05Z","timestamp":1604410145000},"page":"671-676","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis\u2212Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double\u2010Blind, Placebo\u2010Controlled Trial"],"prefix":"10.1002","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7192-9149","authenticated-orcid":false,"given":"Toby M.","family":"Maher","sequence":"first","affiliation":[{"name":"National Heart and Lung Institute Imperial College London and NIHR Clinical Research Facility Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California  Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen D.","family":"Mayes","sequence":"additional","affiliation":[{"name":"University of Texas McGovern Medical School  Houston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kreuter","sequence":"additional","affiliation":[{"name":"Thoraxklinik University of Heidelberg, and the German Center for Lung Research  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3750-6569","authenticated-orcid":false,"given":"Elizabeth R.","family":"Volkmann","sequence":"additional","affiliation":[{"name":"University of California  David Geffen School of Medicine, Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4471-8375","authenticated-orcid":false,"given":"Martin","family":"Aringer","sequence":"additional","affiliation":[{"name":"University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden  Dresden Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5410-5807","authenticated-orcid":false,"given":"Ivan","family":"Castellvi","sequence":"additional","affiliation":[{"name":"Hospital de la Santa Creu i Sant Pau  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5396-0932","authenticated-orcid":false,"given":"Maurizio","family":"Cutolo","sequence":"additional","affiliation":[{"name":"University of Genova IRCCS San Martino Polyclinic Hospital  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Stock","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Ingelheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Schoof","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH, Ingelheim am Rhein  Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarida","family":"Alves","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH, Ingelheim am Rhein  Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Raghu","sequence":"additional","affiliation":[{"name":"University of Washington  Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the SENSCIS Trial Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38098"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-211448"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200706-877OC"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40130"},{"issue":"10","key":"e_1_2_8_6_1","article-title":"Association of short\u2010term longitudinal changes in clinical and physiologic variables with overall survival in patients with systemic sclerosis\u2010associated interstitial lung disease [abstract]","volume":"70","author":"Sobanski V","year":"2018","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201903-0486OC"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-213708"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.141182"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00161-2019"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402584"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1903076"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1908681"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(20)30036-9"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.05.00034805"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00080312"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201709-1845OC"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00155108"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00357-2015"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2017-210035"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201606-458OC"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2665-9913(19)30144-4"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201806-362OC"},{"key":"e_1_2_8_24_1","unstructured":"MayesMD HighlandKB GahlemannM FischerA RaghuG GirardM et al.Effect of anti\u2010topoisomerase I antibody status on decline in lung function in patients with systemic sclerosis\u2010associated interstitial lung disease (SSc\u2010ILD): data from the SENSCIS trial [poster]. American College of Rheumatology: Poster presented at the 2019 Annual Meeting Atlanta Georgia. November 8\u201313 2019. URL:http:\/\/ILDPosters2019.com\/pdf\/ACR_SENSCISATAsubgroups_Mayes.pdf."},{"key":"e_1_2_8_25_1","unstructured":"KuwanaM HighlandKB GahlemannM DentonCP FischerA MayesMD et al.Effects of nintedanib in patients with diffuse and limited cutaneous systemic sclerosis and interstitial lung disease: subgroup analysis of the SENSCIS trial. American College of Rheumatology: Poster presented at the 2019 Annual Meeting Atlanta Georgia. November 8\u201313 2019. 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