{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:07:09Z","timestamp":1792033629544,"version":"4.4.0"},"reference-count":43,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2023,5,20]],"date-time":"2023-05-20T00:00:00Z","timestamp":1684540800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,5,20]],"date-time":"2023-05-20T00:00:00Z","timestamp":1684540800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Rheumatol"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of &gt;10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was \u221282.6 mL\/year in the nintedanib group versus \u2212199.3 mL\/year in the placebo group (difference 116.7 mL\/year [95% CI 7.4, 226.1]; nominal\n                      <jats:italic>p<\/jats:italic>\n                      = 0.037). The most frequent adverse event was diarrhoea, which was reported in 61.9% and 27.7% of patients in the nintedanib and placebo groups, respectively, over the whole trial (median exposure: 17.4 months). Adverse events led to permanent discontinuation of trial drug in 23.8% and 17.0% of subjects in the nintedanib and placebo groups, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      In the INBUILD trial, nintedanib slowed the decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. A graphical abstract is available at:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.globalmedcomms.com\/respiratory\/INBUILD_RA-ILD\">https:\/\/www.globalmedcomms.com\/respiratory\/INBUILD_RA-ILD<\/jats:ext-link>\n                      .\n                      <jats:table-wrap>\n                        <jats:table>\n                          <jats:tbody>\n                            <jats:tr>\n                              <jats:td colspan=\"2\">\n                                <jats:bold>Key Points<\/jats:bold>\n                                \u2022\n                                <jats:italic>In patients with rheumatoid arthritis and progressive pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital capacity (mL\/year) over 52 weeks by 59% compared with placebo.<\/jats:italic>\n                                \u2022\n                                <jats:italic>The adverse event profile of nintedanib was consistent with that previously observed in patients with pulmonary fibrosis, characterised mainly by diarrhoea.<\/jats:italic>\n                                \u2022\n                                <jats:italic>The effect of nintedanib on slowing decline in forced vital capacity, and its safety profile, appeared to be consistent between patients who were taking DMARDs and\/or glucocorticoids at baseline and the overall population of patients with rheumatoid arthritis and progressive pulmonary fibrosis.<\/jats:italic>\n                              <\/jats:td>\n                            <\/jats:tr>\n                          <\/jats:tbody>\n                        <\/jats:table>\n                      <\/jats:table-wrap>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10067-023-06623-7","type":"journal-article","created":{"date-parts":[[2023,5,20]],"date-time":"2023-05-20T10:01:32Z","timestamp":1684576892000},"page":"2311-2319","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":82,"title":["Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial"],"prefix":"10.1007","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9866-0124","authenticated-orcid":false,"given":"Eric L.","family":"Matteson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Aringer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerd R.","family":"Burmester","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heiko","family":"Mueller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lizette","family":"Moros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Kolb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,5,20]]},"reference":[{"key":"6623_CR1","doi-asserted-by":"publisher","first-page":"1583","DOI":"10.1002\/art.27405","volume":"62","author":"T Bongartz","year":"2010","unstructured":"Bongartz T, Nannini C, Medina-Velasquez YF, Achenbach SJ, Crowson CS, Ryu JH, Vassallo R, Gabriel SE, Matteson EL (2010) Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. 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Martin Aringer reports consulting fees for advisory boards and fees for lectures from BI and Roche. Gerd R Burmester reports consulting fees from and has served on speakers\u2019 bureaus for AbbVie, Bristol Myers Squibb, BI, Gilead, Lilly, Merck Sharpe and Dohme, Pfizer, Sanofi, Roche. Heiko Mueller and Lizette Moros are employees of BI. Martin Kolb reports research funding from BI, Pieris and Roche; consulting fees from AbbVie, Algernon, Bellerophon, BI, Cipla, CSL Behring, Horizon, LabCorp, Roche, ShouTi, United Therapeutics; fees for speaking from BI, Novartis, Roche; payment for expert testimony from Roche; has participated on Data Safety Monitoring Boards or Advisory Boards for LabCorp and United Therapeutics; and receives an allowance as Chief Editor of the <i>European Respiratory Journal<\/i>.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}]}}