{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T21:09:01Z","timestamp":1793135341442,"version":"4.5.0"},"reference-count":22,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"unspecified","delay-in-days":52,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"The SENSCIS and SENSCIS-ON trials were supported by Boehringer Ingelheim."}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2025,2,1]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON (\u2018continued nintedanib\u2019 group) and in patients who received placebo in SENSCIS or received nintedanib for \u226428 days in a drug\u2013drug interaction study and then received nintedanib in SENSCIS-ON (\u2018initiated nintedanib\u2019 group).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The continued nintedanib group comprised 197 patients, and the initiated nintedanib group comprised 247 patients (231 from SENSCIS). Diarrhoea was the most frequent adverse event, reported in 152 (77.2%) and 183 (74.1%) patients in the continued nintedanib and initiated nintedanib groups, respectively. Among patients in the continued and initiated nintedanib groups, respectively, 53 (26.9%) and 148 (59.9%) had \u22651\u2009dose reduction, 72 (36.5%) and 131 (53.0%) had \u22651 treatment interruption and 29 (14.7%) and 72 (29.1%) had adverse events that led to treatment discontinuation. Mean (SE) changes in FVC (mL) at week 148 were \u2212189.1 (29.5) in the continued nintedanib group and \u2212126.4 (26.4) in the initiated nintedanib group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-005086","type":"journal-article","created":{"date-parts":[[2025,2,23]],"date-time":"2025-02-23T09:35:29Z","timestamp":1740303329000},"page":"e005086","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02597933","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03313180","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6149-0002","authenticated-orcid":false,"given":"Yannick","family":"Allanore","sequence":"first","affiliation":[{"name":"Department of Rheumatology A, Universit\u00e9 Paris Cit\u00e9, APHP, Cochin Hospital, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2266-9907","authenticated-orcid":false,"given":"Madelon C","family":"Vonk","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0546-8310","authenticated-orcid":false,"given":"Oliver","family":"Distler","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, University Hospital Zurich, University of Zurich, Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arata","family":"Azuma","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Mihara General Hospital, Saitama, Japan"},{"name":"Nippon Medical School, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen D","family":"Mayes","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"James","sequence":"additional","affiliation":[{"name":"Elderbrook Solutions GmbH, Bietigheim-Bissingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronika","family":"Kohlbrenner","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA"}],"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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1412-4453","authenticated-orcid":false,"given":"Dinesh","family":"Khanna","sequence":"additional","affiliation":[{"name":"Scleroderma Program, Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin B","family":"Highland","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,2,23]]},"reference":[{"key":"2025090312100417000_11.1.e005086.1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38098"},{"key":"2025090312100417000_11.1.e005086.2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201903-0486OC"},{"key":"2025090312100417000_11.1.e005086.3","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1177\/2397198319841842","article-title":"Rationale for the evaluation of nintedanib as a treatment for systemic sclerosis-associated interstitial lung disease","volume":"4","author":"Wollin","year":"2019","journal-title":"J Scleroderma Relat Disord"},{"key":"2025090312100417000_11.1.e005086.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1903076"},{"key":"2025090312100417000_11.1.e005086.5","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1002\/acr2.11483","article-title":"Effect of nintedanib on progression of systemic 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