Browsing by Author "Middeke, Jan Moritz"

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    Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease
    (MASSACHUSETTS MEDICAL SOC, 2021-01-01) Zeiser, Robert; Polverelli, Nicola; Ram, Ron; Hashmi, Shahrukh K.; Chakraverty, Ronjon; Middeke, Jan Moritz; Musso, Maurizio; Giebel, Sebastian; Uzay, Ant; Langmuir, Peter; Hollaender, Norbert; Gowda, Maanasa; Stefanelli, Tommaso; Lee, Stephanie J.; Teshima, Takanori; Locatelli, Franco; Investigators, REACH3
    Background Chronic graft-versus-host disease (GVHD), a major complication of allogeneic stem-cell transplantation, becomes glucocorticoid-refractory or glucocorticoid-dependent in approximately 50\% of patients. Robust data from phase 3 randomized studies evaluating second-line therapy for chronic GVHD are lacking. In retrospective surveys, ruxolitinib, a Janus kinase (JAK1-JAK2) inhibitor, showed potential efficacy in patients with glucocorticoid-refractory or -dependent chronic GVHD. Methods This phase 3 open-label, randomized trial evaluated the efficacy and safety of ruxolitinib at a dose of 10 mg twice daily, as compared with the investigator's choice of therapy from a list of 10 commonly used options considered best available care (control), in patients 12 years of age or older with moderate or severe glucocorticoid-refractory or -dependent chronic GVHD. The primary end point was overall response (complete or partial response) at week 24