Posted on April 14th, 2015 by
A Phase III trial finds that Jakafi® (ruxolitinib) more effectively controls symptoms than standard therapy for patients with polycythemia vera (PV). These findings were published in the New England Journal of Medicine.
Polycythemia vera is a slow-growing type of blood cancer that belongs to a group of blood disorders called myeloproliferative neoplasms (MPN). In these disorders, the bone marrow cells that produce blood cells develop and function abnormally. In PV the bone marrow makes too many blood cells, particularly red blood cells. These excess cells thicken the blood and can cause complications, such as a risk of blood clots or bleeding. Without treatment, PV can be life threatening and can eventually progress to more serious blood cancers, such as myelofibrosis or acute leukemia. Effective treatment, however, can significantly decrease risks and complications.
There is no cure for PV. As a result, treatments that help control symptoms of the disease are incredibly important. Common symptoms include tiredness, itching, muscle aches, night sweats, and sweating while awake. Current standard therapy does not effectively control these symptoms.
Jakafi has proven effective in the therapy of PV, including in patients with intolerance or resistance to standard therapy including Hydrea® (hydroxyurea). Jakafi works by inhibiting proteins (JAK1/JAK2 proteins) that may play a role in the development of MPNs by causing the body to make the wrong number of blood cells. Jakafi may provide better symptom management than Hydrea.
Researchers conducted a Phase III study to compare Jakafi with standard therapies in patients who did not respond well to Hydrea. In addition to disease control, the researchers evaluated how effectively Jakafi helped control symptoms of PV. They were divided into two study groups: one received Jakafi, and the other received standard therapy.
At eight months, more patients on Jakafi experienced an at least 50% reduction in symptoms (49% versus 5%). The control rates for specific symptoms with Jakafi were as follows:
Patients receiving Jakafi also had significantly better disease control than those on standard therapy and a higher rate of remission.
These findings suggest that patients with PV experience more effective symptom control with Jakafi compared with standard treatment. Because there is no cure for PV, symptom control is critical for the health and well-being of patients.
Reference: Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus Standard Therapy for the Treatment of Polycythemia Vera. New England Journal of Medicine. 2015 Jan 29;372(5):426-35.
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