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Over a median follow-up of 2.61 years ( range = 0.23-4.12 years ), ruxolitinibtreated patients received a median dose of 19 mg twice-daily ( range not provided ), and the most commonly used treatments in the BAT arm were hydroxycarbamide ( n = 37 ), anagrelide ( n = 25 ), and interferon ( n = 21 ).
Thirty-five patients in the ruxolitinib group discontinued treatment , compared with nine patients in the BAT group . “ However , 30 BAT patients switched their
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initially assigned BAT treatment for various reasons , which indicates a similar rate of treatment ineffectiveness or intolerance ,” the authors wrote .
Rates of complete response ( CR ; primary outcome ) at two-year follow-up were similar in the ruxolitinib and BAT groups ( 27 patients [ 46.5 %] vs . 23 patients [ 44.2 %], respectively ; p = 0.4 ). Rates of partial response ( PR ) were also similar between the two treatment groups : 27 ( 46.5 %) versus 27
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( 51.9 %), respectively . No baseline factors ( including hydroxycarbamide resistance , platelet counts , or JAK2 status ) influenced response rates in multivariate analyses .
Thirteen patients in the study transformed to post-ET myelofibrosis : eight in the ruxolitinib group and five in the BAT group . One ruxolitinib-treated patient transformed to acute myeloid leukemia ( AML ), and , again , transformation-free probability was not significantly different
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between the two arms ( p = 0.29 ).
Ruxolitinib treatment appeared to reduce patients ’ symptom burden , according to an analysis of 85 patients ( 47 in the ruxolitinib group and 38 in the BAT group ) who completed a total symptom score ( TSS ) assessment at baseline and at least once after baseline .
The overall symptom response rate ( defined as a 50 % reduction in TSS during the first 12 months of treatment ) did not differ significantly between the ruxolitinib and BAT groups ( 12 [ 29 %] vs . 6 [ 19 %], respectively ; p = 0.37 ), but the magnitude of symptom reduction appeared to be greater in the ruxolitinib group ( median reduction in TSS = 32 % vs . 0 %; p = 0.03 ). Symptom response was “ rapid ” in the ruxolitinib arm , occurring within two months in eight patients ( 19 %), compared with in one patient ( 3 %) in the BAT group ( p = 0.04 ).
In the safety analysis , which included all 115 patients in the MAJIC-ET trial who received ruxolitinib or BAT , 128 grade 3 / 4 adverse events ( AEs ) occurred in 89 patients , including :
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