Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations

M Marchetti; G Barosi; F Cervantes; G Birgegård; M Griesshammer; C. Harrison; R Hehlmann; J-J Kiladjian; N Kröger; M F McMullin; F Passamonti; A Vannucchi; T Barbui

doi:10.1038/leu.2016.283

Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations

M Marchetti, G Barosi, F Cervantes, G Birgegård, M Griesshammer, C. Harrison, R Hehlmann, J-J Kiladjian, N Kröger, M F McMullin, F Passamonti, A Vannucchi, T Barbui

Queen's University Belfast

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Abstract

Ruxolitinib is an oral JAK1/JAK2 inhibitor approved for the treatment of patients with myelofibrosis (MF) based on the results of two randomized clinical trials. However, discordant indications were provided by regulatory agencies and scientific societies for selecting the most appropriate candidates to this drug. The European LeukemiaNet and the Italian Society of Hematology shared the aim of building evidence-based recommendations for the use of ruxolitinib according to the GRADE methodology. Eighteen patient-intervention-comparator-outcome profiles were listed, each of them comparing ruxolitinib to other therapies with the aim of improving one of three clinical outcomes: a) splenomegaly, b) disease-related symptoms, and c) survival. Ruxolitinib was strongly recommended for improving symptomatic or severe (>15 cm below the costal margin) splenomegaly in patients with an IPSS/DIPSS risk INT2 or high. Ruxolitinib was also strongly recommended for improving systemic symptoms in patients with a MPN10 score higher than 44, refractory severe itching, unintended weight loss not attributable to other causes or unexplained fever. Because of weak evidence, the panel does not recommend ruxolitinib therapy for improving survival. Also, the recommendations given above do not necessarily apply to patients who are candidates for allogeneic stem cell transplant.

Original language	English
Number of pages	7
Journal	Leukemia
Early online date	14 Oct 2016
DOIs	https://doi.org/10.1038/leu.2016.283
Publication status	Early online date - 14 Oct 2016

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Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations
© 2016 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. This work is made available online in accordance with the publisher’s policies.
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Marchetti, M., Barosi, G., Cervantes, F., Birgegård, G., Griesshammer, M., Harrison, C., Hehlmann, R., Kiladjian, J.-J., Kröger, N., McMullin, M. F., Passamonti, F., Vannucchi, A., & Barbui, T. (2016). Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations. Leukemia. Advance online publication. https://doi.org/10.1038/leu.2016.283

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title = "Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations",

abstract = "Ruxolitinib is an oral JAK1/JAK2 inhibitor approved for the treatment of patients with myelofibrosis (MF) based on the results of two randomized clinical trials. However, discordant indications were provided by regulatory agencies and scientific societies for selecting the most appropriate candidates to this drug. The European LeukemiaNet and the Italian Society of Hematology shared the aim of building evidence-based recommendations for the use of ruxolitinib according to the GRADE methodology. Eighteen patient-intervention-comparator-outcome profiles were listed, each of them comparing ruxolitinib to other therapies with the aim of improving one of three clinical outcomes: a) splenomegaly, b) disease-related symptoms, and c) survival. Ruxolitinib was strongly recommended for improving symptomatic or severe (>15 cm below the costal margin) splenomegaly in patients with an IPSS/DIPSS risk INT2 or high. Ruxolitinib was also strongly recommended for improving systemic symptoms in patients with a MPN10 score higher than 44, refractory severe itching, unintended weight loss not attributable to other causes or unexplained fever. Because of weak evidence, the panel does not recommend ruxolitinib therapy for improving survival. Also, the recommendations given above do not necessarily apply to patients who are candidates for allogeneic stem cell transplant. ",

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AU - Harrison, C.

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AU - Kiladjian, J-J

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AU - McMullin, M F

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AU - Vannucchi, A

AU - Barbui, T

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AB - Ruxolitinib is an oral JAK1/JAK2 inhibitor approved for the treatment of patients with myelofibrosis (MF) based on the results of two randomized clinical trials. However, discordant indications were provided by regulatory agencies and scientific societies for selecting the most appropriate candidates to this drug. The European LeukemiaNet and the Italian Society of Hematology shared the aim of building evidence-based recommendations for the use of ruxolitinib according to the GRADE methodology. Eighteen patient-intervention-comparator-outcome profiles were listed, each of them comparing ruxolitinib to other therapies with the aim of improving one of three clinical outcomes: a) splenomegaly, b) disease-related symptoms, and c) survival. Ruxolitinib was strongly recommended for improving symptomatic or severe (>15 cm below the costal margin) splenomegaly in patients with an IPSS/DIPSS risk INT2 or high. Ruxolitinib was also strongly recommended for improving systemic symptoms in patients with a MPN10 score higher than 44, refractory severe itching, unintended weight loss not attributable to other causes or unexplained fever. Because of weak evidence, the panel does not recommend ruxolitinib therapy for improving survival. Also, the recommendations given above do not necessarily apply to patients who are candidates for allogeneic stem cell transplant.

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Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations

Abstract

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