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Response to ruxolitinib in patients with intermediate-1-, intermediate-2-, and high-risk myelofibrosis: results of the UK ROBUST Trial

Mead, Adam J., Milojkovic, Dragana, Knapper, Steven ORCID: https://orcid.org/0000-0002-6405-4441, Garg, Mamta, Chacko, Joseph, Farquharson, Mira, Yin, John, Ali, Sahra, Clark, Richard E., Andrews, Chris, Dawson, Meryem Ktiouet and Harrison, Claire 2015. Response to ruxolitinib in patients with intermediate-1-, intermediate-2-, and high-risk myelofibrosis: results of the UK ROBUST Trial. British Journal of Haematology 170 (1) , pp. 29-39. 10.1111/bjh.13379

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Abstract

Myelofibrosis is characterized by splenomegaly and debilitating constitutional symptoms that negatively impact patients’ quality of life. ROBUST, a UK, open-label, phase II study, evaluated the safety and efficacy of ruxolitinib in patients with myelofibrosis (N = 48), including intermediate-1 risk patients. The primary composite endpoint was the proportion of patients achieving treatment success [≥50% reduction in palpable spleen length and/or a ≥50% decrease in Myelofibrosis Symptom Assessment Form Total Symptom Score (MF-SAF TSS)] at 48 weeks. This was the first time that efficacy of ruxolitinib in myelofibrosis has been evaluated based on these criteria and the first time the MF-SAF was used in a population of patients solely from the United Kingdom. Overall, 50% of patients and 57% of intermediate-1 risk patients, achieved treatment success; reductions in spleen length and symptoms were observed in all risk groups. The majority of patients (66�7%) experienced ≥50% reductions from baseline in spleen length at any time. Improvements in MF-SAF TSS were seen in 80�0%, 72�7%, and 72�2% of intermediate-1, intermediate-2, and high-risk patients, respectively. Consistent with other studies of ruxolitinib, the most common haematological adverse events were anaemia and thrombocytopenia. Results indicate that most patients with myelofibrosis, including intermediate-1 risk patients, may benefit from ruxolitinib treatment.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Medicine
Publisher: Wiley-Blackwell
ISSN: 0007-1048
Date of First Compliant Deposit: 26 September 2017
Date of Acceptance: 30 March 2015
Last Modified: 03 Nov 2022 09:28
URI: https://orca.cardiff.ac.uk/id/eprint/105005

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