There was no significant difference in symptom improvement between continued treatment with hydroxyurea and switching to ruxolitinib in patients with polycythemia vera who reported disease-related symptoms while receiving a stable dose of hydroxyurea, according to a study published in the British Journal of Haematology.1
Many patients with polycythemia vera require more than low-dose aspirin and phlebotomy to achieve their treatment goals. Hydroxyurea is effective for controlling blood cell counts in some patients, but polycythemia vera-related symptoms are typically not well-controlled with hydroxyurea treatment.
The phase 3 RESPONSE trial demonstrated that ruxolitinib was superior to best available therapy with respect to hematocrit control in patients who had inadequately responded to, or were intolerant of, hydroxyurea. It was also associated with improvement in disease-related symptoms. Therefore, researchers sought to evaluate the impact of continued hydroxyurea vs switching to ruxolitinib on disease-related symptom burden in patients with polycythemia vera.
For the double-blind, phase 3b RELIEF study (ClinicalTrials.gov Identifier: NCT01632904), investigators enrolled 110 patients well-controlled on a stable dose of hydroxyurea and randomly assigned them 1:1 to receive ruxolitinib orally twice daily or continued hydroxyurea. Patients continuing hydroxyurea were permitted to crossover to ruxolitinib after week 16.
Results showed that there was no significant difference in the level of symptom improvement from baseline between the 2 treatment arms (odds ratio [OR], 1.82; 95% CI, 0.82-4.04; P =.139).
However, subgroup analyses demonstrated a significant improvement in disease-related symptoms in patients with stable screening-to-baseline symptom scores receiving ruxolitinib vs those who receiving continued hydroxyurea (P =.0346).
1. Mesa R, Vannucchi AM, Yacoub A, et al. The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythaemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF). Br J Haematol. 2016 Nov 8. doi: 10.1111/bjh.14382. [Epub ahead of pub]