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Jakafi Superior to Standard Treatment in Polycythemia Vera

Treatment with Jakafi® (ruxolitinib) was superior to best available treatment among patients with inadequately controlled polycythemia vera (PV). These results were recently presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.

PV is a type of myeloproliferative neoplasm (MPN) in which the body produces a larger than normal amount of red blood cells. Because of this, patients with PV have an increased risk for blood clots and cardiovascular events, as well as an enlarged spleen, and symptoms such as fatigue, itching, night sweats, bone pain, fever, and weight loss. Approximately 100,000 individuals in the U.S. are currently living with PV.

The lab test used to determine the percentage of red blood cells in the blood is called a hematocrit. Patients with PV have elevated hematocrit levels without treatment. Hematocrit levels are closely monitored among patients with PV to determine the effectiveness of treatment.

Treatment for PV can include a phlebotomy (removal of blood from the body), plus aspirin (to reduce the risk of blood clots). If treatment with phlebotomy stops working, patients can then receive treatment with hydroxyurea or interferon.

Jakafi is an agent that inhibits the JAK1/JAK2 pathway – a cellular pathway implicated in the progression of PV. It has been approved by the United States Food and Drug Administration (FDA), and is the first-in-class JAK1/JAK2 pathway inhibitor, for the treatment of PV that has an inadequate response to hydroxyurea, or for patients who are not able to tolerate hydroxyurea.

Researchers recently announced data from a phase 3 trial referred to as the RESPONSE-2 study, further evaluating the effectiveness of Jakafi in the treatment of PV.

The trial included 149 patients with PV who either did not achieve a response to hydroxyurea, or who were intolerant to hydroxyurea. Patients were dependent on phlebotomy to control their hematocrit levels, but did not have an enlarged spleen.

Patients were treated with either Jakafi or best available therapy (BAT), and were directly compared. The data presented at the 2016 EHA meeting consisted of 28 weeks of follow-up of these patients.

  • Hematocrit levels were maintained in 62.2% of patients treated with Jakafi, compared with only 18.7% of patients treated with BAT.
  • Complete remission was achieved in 23% of patients treated with Jakafi, compared with 5.3% of patients treated with BAT.
  • Improvement in PV symptoms was achieved in 50% of patients treated with Jakafi, compared with 7.7% of patients treated with BAT.
  • Overall, Jakafi was well tolerated by patients.

The researchers concluded that Jakafi provides superior results compared to BAT among patients with PV who have stopped responding to, or are intolerant to hydroxyurea. These results are promising, and provide an effective and well-tolerated treatment option among patients with uncontrolled PV.

Reference : Passamonti F, Griesshammer M, Palandri F, et al. Ruxolitinib Proves Superior to Best Available Therapy in Patients with Polycythemia Vera (PV) and a Nonpalpable Spleen: Results from the Phase IIIb RESPONSE-2 Study. Abstract ##S112. 21st Congress of the European Hematology Association (EHA) Copenhagen, Denmark, 2016

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