A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis

Srdan Verstovsek; Ruben A Mesa; Jason Gotlib; Richard S Levy; Vikas Gupta; John F DiPersio; John Catalano; Michael Deininger; Carole Miller; Richard Silver; Moshe Talpaz; Elliott F Winton; Jimmie H Harvey; Murat O Arcasoy; Elizabeth Hexner; Roger M Lyons; Ronald Paquette; Azra Raza; Kris Vaddi; Susan Erickson-Vittanen; Iphigenia L Koumenis; William Sun; Victor Sandor; Hagop M Kantarjian

doi:10.1056/NEJMoa1110557

A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis

Srdan Verstovsek, Ruben A Mesa, Jason Gotlib, Richard S Levy, Vikas Gupta, John F DiPersio, John Catalano, Michael Deininger, Carole Miller, Richard Silver, Moshe Talpaz, Elliott F Winton, Jimmie H Harvey, Murat O Arcasoy, Elizabeth Hexner, Roger M Lyons, Ronald Paquette, Azra Raza, Kris Vaddi, Susan Erickson-VittanenIphigenia L Koumenis, William Sun, Victor Sandor, Hagop M Kantarjian

Medicine Monash Health

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Abstract

In this doube-blind trial, we randomly assigned patients with intermediate-2 or high-risk myelofibrosis to twice-daily oral ruxolitinib (155 patients) or placebo (154 patients). The primary end point was the proportion of patients with a reduction in spleen volume of 35 or more at 24 weeks, assessed by means of magnetic resonance imaging. Secondary end points included the durability of response, changes in symptom burden (assessed by the total symptom score) and overall survival.

Original language	English
Pages (from-to)	799 - 807
Number of pages	9
Journal	The New England Journal of Medicine
Volume	366
Issue number	9
DOIs	https://doi.org/10.1056/NEJMoa1110557
Publication status	Published - 2012

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Verstovsek, S., Mesa, R. A., Gotlib, J., Levy, R. S., Gupta, V., DiPersio, J. F., Catalano, J., Deininger, M., Miller, C., Silver, R., Talpaz, M., Winton, E. F., Harvey, J. H., Arcasoy, M. O., Hexner, E., Lyons, R. M., Paquette, R., Raza, A., Vaddi, K., ... Kantarjian, H. M. (2012). A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. The New England Journal of Medicine, 366(9), 799 - 807. https://doi.org/10.1056/NEJMoa1110557

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title = "A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis",

abstract = "In this doube-blind trial, we randomly assigned patients with intermediate-2 or high-risk myelofibrosis to twice-daily oral ruxolitinib (155 patients) or placebo (154 patients). The primary end point was the proportion of patients with a reduction in spleen volume of 35 or more at 24 weeks, assessed by means of magnetic resonance imaging. Secondary end points included the durability of response, changes in symptom burden (assessed by the total symptom score) and overall survival.",

author = "Srdan Verstovsek and Mesa, {Ruben A} and Jason Gotlib and Levy, {Richard S} and Vikas Gupta and DiPersio, {John F} and John Catalano and Michael Deininger and Carole Miller and Richard Silver and Moshe Talpaz and Winton, {Elliott F} and Harvey, {Jimmie H} and Arcasoy, {Murat O} and Elizabeth Hexner and Lyons, {Roger M} and Ronald Paquette and Azra Raza and Kris Vaddi and Susan Erickson-Vittanen and Koumenis, {Iphigenia L} and William Sun and Victor Sandor and Kantarjian, {Hagop M}",

year = "2012",

doi = "10.1056/NEJMoa1110557",

language = "English",

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Verstovsek, S, Mesa, RA, Gotlib, J, Levy, RS, Gupta, V, DiPersio, JF, Catalano, J, Deininger, M, Miller, C, Silver, R, Talpaz, M, Winton, EF, Harvey, JH, Arcasoy, MO, Hexner, E, Lyons, RM, Paquette, R, Raza, A, Vaddi, K, Erickson-Vittanen, S, Koumenis, IL, Sun, W, Sandor, V & Kantarjian, HM 2012, 'A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis', The New England Journal of Medicine, vol. 366, no. 9, pp. 799 - 807. https://doi.org/10.1056/NEJMoa1110557

TY - JOUR

T1 - A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis

AU - Verstovsek, Srdan

AU - Mesa, Ruben A

AU - Gotlib, Jason

AU - Levy, Richard S

AU - Gupta, Vikas

AU - DiPersio, John F

AU - Catalano, John

AU - Deininger, Michael

AU - Miller, Carole

AU - Silver, Richard

AU - Talpaz, Moshe

AU - Winton, Elliott F

AU - Harvey, Jimmie H

AU - Arcasoy, Murat O

AU - Hexner, Elizabeth

AU - Lyons, Roger M

AU - Paquette, Ronald

AU - Raza, Azra

AU - Vaddi, Kris

AU - Erickson-Vittanen, Susan

AU - Koumenis, Iphigenia L

AU - Sun, William

AU - Sandor, Victor

AU - Kantarjian, Hagop M

PY - 2012

Y1 - 2012

N2 - In this doube-blind trial, we randomly assigned patients with intermediate-2 or high-risk myelofibrosis to twice-daily oral ruxolitinib (155 patients) or placebo (154 patients). The primary end point was the proportion of patients with a reduction in spleen volume of 35 or more at 24 weeks, assessed by means of magnetic resonance imaging. Secondary end points included the durability of response, changes in symptom burden (assessed by the total symptom score) and overall survival.

AB - In this doube-blind trial, we randomly assigned patients with intermediate-2 or high-risk myelofibrosis to twice-daily oral ruxolitinib (155 patients) or placebo (154 patients). The primary end point was the proportion of patients with a reduction in spleen volume of 35 or more at 24 weeks, assessed by means of magnetic resonance imaging. Secondary end points included the durability of response, changes in symptom burden (assessed by the total symptom score) and overall survival.

UR - http://www.nejm.org/doi/pdf/10.1056/NEJMoa1110557

U2 - 10.1056/NEJMoa1110557

DO - 10.1056/NEJMoa1110557

M3 - Article

SN - 0028-4793

VL - 366

SP - 799

EP - 807

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 9

ER -

A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis

Abstract

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