{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T11:49:08Z","timestamp":1793015348749,"version":"4.5.0"},"reference-count":31,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,2,13]],"date-time":"2022-02-13T00:00:00Z","timestamp":1644710400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Using data from the SENSCIS trial, these analyses were undertaken to assess the effects of nintedanib versus placebo in subgroups of patients with systemic sclerosis\u2013associated interstitial lung disease (SSc\u2010ILD), based on characteristics previously identified as being associated with the progression of SSc\u2010ILD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with SSc\u2010ILD were randomized to receive either nintedanib or placebo, stratified by anti\u2013topoisomerase I antibody (ATA) status. We assessed the rate of decline in forced vital capacity (FVC) (expressed in ml\/year) over 52\u2009weeks in subgroups based on baseline ATA status, modified Rodnan skin thickness score (MRSS) (&lt;18 versus \u226518), and SSc subtype (limited cutaneous SSc [lcSSc] versus diffuse cutaneous SSc [dcSSc]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At baseline, 60.8% of 576 patients who received treatment with either nintedanib or placebo were positive for ATA, 51.9% had dcSSc, and 77.5% of 574 patients with MRSS data available had an MRSS of &lt;18. The effect of nintedanib versus placebo on reducing the rate of decline in FVC (ml\/year) was numerically more pronounced in ATA\u2010negative patients compared to ATA\u2010positive patients (adjusted difference in the rate of FVC decline, 57.2 ml\/year [95% confidence interval (95% CI) \u20133.5, 118.0] versus 29.9 ml\/year [95% CI \u201319.1, 78.8]), in patients with a baseline MRSS \u226518 compared to those with a baseline MRSS of &lt;18 (adjusted difference in the rate of FVC decline, 88.7 ml\/year [95% CI 7.7, 169.8] versus 26.4 ml\/year [95% CI \u201316.8, 69.6]), and in patients with dcSSc compared to those with lcSSc (adjusted difference in the rate of FVC decline, 56.6 ml\/year [95% CI 3.2, 110.0] versus 25.3 ml\/year [95% CI \u201328.9, 79.6]). However, all exploratory interaction <jats:italic>P<\/jats:italic> values were nonsignificant (all <jats:italic>P<\/jats:italic>\u2009&gt;\u20090.05), indicating that there was no heterogeneity in the effect of nintedanib versus placebo between these subgroups of patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In patients with SSc\u2010ILD, reduction in the annual rate of decline in FVC among patients receiving nintedanib compared to those receiving placebo was not found to be heterogenous across subgroups based on ATA status, MRSS, or SSc subtype.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41965","type":"journal-article","created":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T01:06:26Z","timestamp":1631495186000},"page":"518-526","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Nintedanib in Patients With Systemic Sclerosis\u2013Associated Interstitial Lung Disease: Subgroup Analyses by Autoantibody Status and Modified Rodnan Skin Thickness Score"],"prefix":"10.1002","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"first","affiliation":[{"name":"Nippon Medical School Graduate School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannick","family":"Allanore","sequence":"additional","affiliation":[{"name":"Descartes University AP\u2010HP, and Cochin Hospital  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3975-8938","authenticated-orcid":false,"given":"Christopher P.","family":"Denton","sequence":"additional","affiliation":[{"name":"University College London Division of Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7408-9333","authenticated-orcid":false,"given":"J\u00f6rg H. W.","family":"Distler","sequence":"additional","affiliation":[{"name":"University of Erlangen\u2013Nuremberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Steen","sequence":"additional","affiliation":[{"name":"Georgetown University  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1412-4453","authenticated-orcid":false,"given":"Dinesh","family":"Khanna","sequence":"additional","affiliation":[{"name":"University of Michigan  Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Matucci\u2010Cerinic","sequence":"additional","affiliation":[{"name":"University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5070-2535","authenticated-orcid":false,"given":"Maureen D.","family":"Mayes","sequence":"additional","affiliation":[{"name":"University of Texas McGovern 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