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:
- Tiredness: reduced by 50% (compared to 4% with standard therapy)
- Itching: reduced by 95% (compared to 2% with standard therapy)
- Muscle ache: reduced by 61% (compared with a minor increase with standard therapy)
- Night sweats: reduced by 100% (compared with a 4% increase with standard therapy)
- Sweating while awake: reduced by 100% (compared to 4% with standard therapy)
- Headache: reduced by 52% (compared to 11% with standard therapy)
- Concentration problems: reduced by 44% (compared to 17% with standard therapy)
- Dizziness: reduced by 80% (compared to 8% with standard therapy)
- Skin redness: reduced by 64% (compared with a 5% increase with standard therapy)
- Vision problems: reduced by 42% (compared with an 11% increase with standard therapy)
- Numbness and tingling in hands or feet: reduced by 37% (compared to 16% with standard therapy)
- Feeling full quickly when eating: reduced by 94% (compared to no change with standard therapy)
- Stomach discomfort: reduced by 66% (compared to a 1% increase with standard therapy)
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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