{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T17:13:33Z","timestamp":1784740413629,"version":"3.55.0"},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T00:00:00Z","timestamp":1691020800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T00:00:00Z","timestamp":1691020800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100007514","name":"Universit\u00e0 di Pisa","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100007514","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Inflammopharmacol"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Objective<\/jats:title>\n                <jats:p>Nintedanib (NIN) is an antifibrotic drug approved to slow the progression of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-related interstitial lung disease (SSc-ILD). NIN can frequently cause gastrointestinal adverse effects. We aimed to investigate the NIN safety profile in a real life setting, comparing IPF and SSc-ILD patients and evaluating the strategies adopted to manage NIN adverse effects.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients taking NIN for IPF or SSc-ILD were enrolled. Alongside epidemiological and disease-specific data, the period of NIN use and the need for dosage reduction and\/or interruption were investigated. Particular attention was paid to possible adverse effects and strategies adopted to manage them.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Twenty-seven SSc-ILD and 82 IPF patients were enrolled. No significant differences emerged between the two cohorts regarding the frequency of any possible adverse effect. Although the rates of NIN dosage reduction or interruption were similar between the two subgroups, SSc-ILD presented a mean period before NIN dosage reduction and NIN interruption significantly shorter than IPF (3\u2009\u00b1\u20092.6 vs 10.5\u2009\u00b1\u20098.9\u00a0months\u2014p\u2009&lt;\u20090.001 and 2.3\u2009\u00b1\u20090.5 vs 10.3\u2009\u00b1\u20099.9\u00a0months\u2014p\u2009=\u20090.008, respectively). Several different strategies were tried to manage NIN adverse effects: especially in SSc-ILD, the variable combination of diet adjustment set by a nutritionist, probiotics and diosmectite was ultimately successful in maintaining patients on an adequate dose of NIN.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>We presented data on the NIN safety profile in a real life setting, which was similar between SSc-ILD and IPF. A combination of multiple managing strategies and dose adjustment appears essential to cope optimally with NIN adverse effects.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10787-023-01286-x","type":"journal-article","created":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T07:01:26Z","timestamp":1691046086000},"page":"2445-2449","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Real life data on nintedanib safety: idiopathic pulmonary fibrosis versus systemic sclerosis-interstitial lung disease and strategies adopted to manage adverse effects"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4788-5729","authenticated-orcid":false,"given":"Marco","family":"Di Battista","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Tavanti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Pistelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Carrozzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mattia","family":"Da Rio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Rossi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Puccetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Tavoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Romei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Morganti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Della Rossa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Mosca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,8,3]]},"reference":[{"key":"1286_CR1","doi-asserted-by":"publisher","first-page":"173","DOI":"10.1159\/000495046","volume":"97","author":"E Bendstrup","year":"2019","unstructured":"Bendstrup E, Wuyts W, Alfaro T, Chaudhuri N, Cornelissen R, Kreuter M, Melgaard Nielsen K, M\u00fcnster AMB, Myll\u00e4rniemi M, Ravaglia C, Vanuytsel T, Wijsenbeek M (2019) Nintedanib in idiopathic pulmonary fibrosis: practical management recommendations for potential adverse events. Respiration 97:173\u2013184. https:\/\/doi.org\/10.1159\/000495046","journal-title":"Respiration"},{"key":"1286_CR2","doi-asserted-by":"publisher","first-page":"e0251636","DOI":"10.1371\/journal.pone.0251636","volume":"16","author":"CH Chen","year":"2021","unstructured":"Chen CH, Lin HC, Wang YH, Wang CY, Lin YS, Lai CC (2021) The safety of nintedanib for the treatment of interstitial lung disease: a systematic review and meta-analysis of randomized controlled trials. PLoS ONE 16:e0251636. https:\/\/doi.org\/10.1371\/journal.pone.0251636","journal-title":"PLoS ONE"},{"key":"1286_CR3","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1186\/s12931-022-01974-2","volume":"23","author":"V Cottin","year":"2022","unstructured":"Cottin V, Martinez FJ, Jenkins RG, Belperio JA, Kitamura H, Molina-Molina M, Tschoepe I, Coeck C, Lievens D, Costabel U (2022) Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res 23:85. https:\/\/doi.org\/10.1186\/s12931-022-01974-2","journal-title":"Respir Res"},{"key":"1286_CR4","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1016\/S2213-2600(18)30339-4","volume":"7","author":"B Crestani","year":"2019","unstructured":"Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M (2019) Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med 7:60\u201368. https:\/\/doi.org\/10.1016\/S2213-2600(18)30339-4","journal-title":"Lancet Respir Med"},{"key":"1286_CR5","doi-asserted-by":"publisher","first-page":"2518","DOI":"10.1056\/nejmoa1903076","volume":"380","author":"O Distler","year":"2019","unstructured":"Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM (2019) Nintedanib for systemic sclerosis-associated interstitial lung disease. N Engl J Med 380:2518\u20132528. https:\/\/doi.org\/10.1056\/nejmoa1903076","journal-title":"N Engl J Med"},{"key":"1286_CR6","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1186\/s12931-021-01695-y","volume":"22","author":"I Glaspole","year":"2021","unstructured":"Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E (2021) Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res 22:125. https:\/\/doi.org\/10.1186\/s12931-021-01695-y","journal-title":"Respir Res"},{"key":"1286_CR7","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1016\/S2213-2600(20)30330-1","volume":"9","author":"KB Highland","year":"2021","unstructured":"Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM (2021) Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med 9:96\u2013106. https:\/\/doi.org\/10.1016\/S2213-2600(20)30330-1","journal-title":"Lancet Respir Med"},{"key":"1286_CR8","doi-asserted-by":"publisher","first-page":"2071","DOI":"10.1056\/nejmoa1402584","volume":"370","author":"L Richeldi","year":"2014","unstructured":"Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR (2014) Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 370:2071\u20132082. https:\/\/doi.org\/10.1056\/nejmoa1402584","journal-title":"N Engl J Med"},{"key":"1286_CR9","doi-asserted-by":"publisher","first-page":"1478","DOI":"10.1136\/annrheumdis-2020-217331","volume":"79","author":"JR Seibold","year":"2020","unstructured":"Seibold JR, Maher TM, Highland KB, Assassi S, Azuma A, Hummers LK, Costabel U, Von Wangenheim U, Kohlbrenner V, Gahlemann M, Alves M, Distler O (2020) Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial. Ann Rheum Dis 79:1478\u20131484. https:\/\/doi.org\/10.1136\/annrheumdis-2020-217331","journal-title":"Ann Rheum Dis"}],"container-title":["Inflammopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10787-023-01286-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10787-023-01286-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10787-023-01286-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,25]],"date-time":"2023-09-25T01:14:38Z","timestamp":1695604478000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10787-023-01286-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,3]]},"references-count":9,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["1286"],"URL":"https:\/\/doi.org\/10.1007\/s10787-023-01286-x","relation":{},"ISSN":["0925-4692","1568-5608"],"issn-type":[{"value":"0925-4692","type":"print"},{"value":"1568-5608","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,3]]},"assertion":[{"value":"1 June 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 June 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declaration"}},{"value":"The authors declare that they have no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}