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Ruxolitinib was the first drug approved for aGvHD, based on results of the REACH2 trial; however, real-world data are limited. We retrospectively analyzed the safety and efficacy of ruxolitinib for treatment of aGvHD at our center from March 2016 to August 2022 and assessed biomarkers of risk. We identified 49 patients receiving ruxolitinib as second- (33\/49), third- (11\/49), fourth- (3\/49), or fifth-line (2\/49) treatment. Ruxolitinib was started on median day 11 (range, 7\u201321) after aGvHD onset; median duration of administration was 37 days (range, 20\u201386), with 10 patients continuing treatment at last follow-up. Median follow-up period was 501 days (range, 95\u2013905). In the primary analysis at the 1-month assessment, overall response rate was 65%, and failure-free survival was 78%. Infectious complications\u2009\u2265\u2009CTCAE Grade III were observed in 10\/49 patients within 1-month followup. Patients responding to ruxolitinib therapy required fewer steroids and exhibited lower levels of the serum biomarkers regenerating islet-derived protein 3-alpha, suppression of tumorigenicity 2, and the Mount Sinai Acute GVHD International Consortium algorithm probability. A univariate regression model revealed steroid-dependent aGvHD as a significant predictor of better response to ruxolitinib. Within 6-months follow-up, four patients experienced recurrence of underlying malignancy, and eight died due to treatment-related mortality. Overall, ruxolitinib was welltolerated and showed response in heavily pretreated patients, with results comparable to those of the REACH2 trial. Biomarkers may be useful predictors of response to ruxolitinib.<\/jats:p>","DOI":"10.1007\/s00277-024-05696-x","type":"journal-article","created":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T01:01:31Z","timestamp":1719277291000},"page":"3071-3081","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Ruxolitinib for the treatment of acute graft-versus-host disease: a retrospective analysis"],"prefix":"10.1007","volume":"103","author":[{"given":"Alexander","family":"Denk","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Edinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Weber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernst","family":"Holler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Fante","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Meedt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sibel","family":"Gunes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Poeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Mittermaier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang","family":"Herr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Wolff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,25]]},"reference":[{"key":"5696_CR1","doi-asserted-by":"publisher","first-page":"391","DOI":"10.2217\/imt-2017-0156","volume":"10","author":"M Jagasia","year":"2018","unstructured":"Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV (2018) Ruxolitinib for the treatment of patients with steroid-refractory GvHD: an introduction to the REACH trials. 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Sibel G\u00fcne\u015f is an employee of Novartis Pharma AG. All other authors have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the responsible institution and\/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all patients for being included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Daniel Wolff received honoraria from Mallinckrodt, Neovi, Takeda, Sanofi, Incyte and Novartis. Sibel G\u00fcne\u015f is an employee of Novartis Pharma AG. All other authors have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}