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

Lynda Foltz*, Gian Matteo Pica, Hacene Zerazhi, Jan Van Droogenbroeck, Sorin Visanica, Enrique Báez de la Fuente, Brian Leber, António Medina de Almeida, Dana Ranta, Jean Jacques Kiladjian, Linda Chrit, Albert Kandra, Juliane Morando, Timothy Devos

*Autor correspondente para este trabalho

Resultado de pesquisarevisão de pares

2 Citações (Scopus)

Resumo

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.
Idioma originalEnglish
Páginas (de-até)3493-3502
Número de páginas10
RevistaLeukemia and Lymphoma
Volume60
Número de emissão14
DOIs
Estado da publicaçãoPublicado - 6 dez 2019
Publicado externamenteSim

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