study design of a phase 3 randomized open label multicenter study to evaluate ruxolitinib over bat in patients with corticosteroid refractory chronic graft vs host disease after allogeneic hematopoietic stem cell transplantation reach 3

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Efficacy and Safety of Ruxolitinib in Regularly Transfused Patients with Thalassemia: Results from Single-Arm, Multicenter, Phase 2a Truth Study

58th Annual Meeting and Exposition of the American-Society-of-Hematology (ASH) -- DEC 03-06, 2016 -- San Diego, CAWOS: 000394446800050Amer Soc HematolShire; Cerus; NovartisNovartis; Jansen-Cilag; RocheRoche Holding; PfizerPfizer; CelgeneAydinok: Shire: Research Funding; Cerus: Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Karakas: Novartis: Research Funding. Siritanaratkul: Jansen-Cilag: Research Funding; Novartis: Research Funding; Roche: Research Funding; Pfizer: Research Funding. Kattamis: Novartis: Honoraria, Research Funding; ApoPharma: Honoraria. Hollaender: Novartis: Employment. Mahuzier: Novartis: Employment. Gadbaw: Novartis: Employment. Taher: Novartis: Honoraria, Research Funding; Celgene: Research Funding

Efficacy and safety of ruxolitinib in regularly transfused patients with thalassemia: results from a phase 2a study

WOS: 000419974000015PubMed ID: 29097381Novartis Pharmaceuticals CorporationNovartisThe study is supported by Novartis Pharmaceuticals Corporation

Study Design of a Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate Ruxolitinib Over BAT in Patients with Corticosteroid-Refractory Chronic Graft vs Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation (REACH-3)

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Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies

Ruxolitinib was well tolerated and superior to best available therapy (including interferon [IFN]) in controlling hematocrit without phlebotomy eligibility, normalizing blood counts, and improving polycythemia vera-related symptoms in the Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care (RESPONSE) studies. This ad hoc analysis focuses on ruxolitinib in relation to IFN in the RESPONSE studies, with attention on the following: (1) safety and efficacy of ruxolitinib and best available therapy in patients who received IFN before study randomization, (2) safety and efficacy of IFN during randomized treatment in best available therapy arm, and (3) use of ruxolitinib after crossover from best available therapy in IFN-treated patients. IFN exposure before randomization had little effect on the efficacy or safety of ruxolitinib. In the randomized treatment arms, ruxolitinib was superior to IFN in efficacy [hematocrit control (RESPONSE = 60% of ruxolitinib vs 23% of IFN patients; RESPONSE-2 = 62% of ruxolitinib vs 15% of IFN patients)] and was tolerated better in hydroxyurea-resistant or hydroxyurea-intolerant patients. After crossing over to receive ruxolitinib, patients who had initially received IFN and did not respond had improved hematologic and spleen responses (62% of patients at any time after crossover) and an overall reduction in phlebotomy procedures. Rates and incidences of the most common adverse events decreased after crossover to ruxolitinib, except for infections (primarily grade 1 or 2). These data suggest that ruxolitinib is efficacious and well tolerated in patients who were previously treated with IFN. The RESPONSE (NCT01243944) and RESPONSE-2 (NCT02038036) studies were registered at clinicaltrials.gov