Chronic Myeloproliferative Syndromes
نویسندگان
چکیده
© F rra ta St ort i F ou nd ati on approved in November 2011 by the US Food and Drug Administration for the treatment of intermediateor highrisk myelofibrosis and more recently by Health Canada and the European Commission for the treatment of myelofibrosis-related splenomegaly or symptoms. Ruxolitinib was approved based on data from two pivotal phase 3 COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (COMFORT) trials: COMFORT-I was double-blind and placebo-controlled and COMFORTII was an open-label study that compared ruxolitinib with best available therapy (BAT). In both studies, patients who received ruxolitinib had rapid and durable reductions in splenomegaly and improvements in disease-related symptoms, role functioning and QoL measures. In contrast, patients in the control arms of both of these studies generally had increases in splenomegaly and worsening of symptoms, demonstrating that non–JAK inhibitor treatments were not efficacious. Here, we present a post hoc analysis specifically evaluating the efficacy outcomes and safety of the placebo arm of COMFORT-I compared with those of the BAT arm of COMFORT-II.
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