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- Title
Response to ruxolitinib in patients with intermediate-1-, intermediate-2-, and high-risk myelofibrosis: results of the UK ROBUST Trial.
- Authors
Mead, Adam J.; Milojkovic, Dragana; Knapper, Steven; Garg, Mamta; Chacko, Joseph; Farquharson, Mira; Yin, John; Ali, Sahra; Clark, Richard E.; Andrews, Chris; Dawson, Meryem Ktiouet; Harrison, Claire
- 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.
- Subjects
DRUG efficacy; JANUS kinases; ANEMIA; THROMBOCYTOPENIA; DRUG side effects; MYELOFIBROSIS; SPLEEN; PATIENTS; THERAPEUTICS
- Publication
British Journal of Haematology, 2015, Vol 170, Issue 1, p29
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.13379