Safety and efficacy findings from the open-label, multicenter, phase 3b, expanded treatment protocol study of ruxolitinib for treatment of patients with polycythemia vera who are resistant/intolerant to hydroxyurea and for whom no alternative treatments are available

Autor: Foltz, Lynda, Pica, Gian-Matteo, Zerazhi, Hacene, Van Droogenbroeck, Jan, Visanica, Sorin, Báez de la Fuente, Enrique, Leber, Brian, de Almeida, Antonio Medina, Ranta, Dana, Kiladjian, Jean-Jacques, Chrit, Linda, Kandra, Albert, Morando, Juliane, Devos, Timothy
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Zdroj: Leukemia & Lymphoma; Dec2019, Vol. 60 Issue 14, p3493-3502, 10p
Abstrakt: Ruxolitinib was recently approved for the treatment of patients with polycythemia vera who are resistant/intolerant to hydroxyurea based on data from the RESPONSE studies. This phase 3b, Expanded Treatment Protocol study (NCT02292446) of ruxolitinib for hydroxyurea-resistant/intolerant patients with polycythemia vera (N = 161: median exposure = 25.1 weeks) further evaluated the safety of ruxolitinib. Adverse events (AEs) led to dose adjustment/interruption in 37.9% of patients and study drug discontinuation in 8.7% of patients. The most common hematologic AEs included anemia and thrombocytosis; while headache and diarrhea were the most frequent nonhematologic AEs. At week 24, 45.3% of patients achieved hematocrit control; hematologic remission was seen in 18% of patients. At least, 50% of reduction in spleen length was achieved in 86.7% of patients from baseline at any time. The observed safety profile of ruxolitinib was consistent and the efficacy results were similar to the observed values in the RESPONSE studies. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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