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Ruxolitinib’s Impact on Polycythemia Vera Symptoms

Br J Haematol; ePub 2016 Nov 8; Mesa, et al

People who took ruxolitinib tended to experience improvement in polycythemia vera (PV) symptoms compared with those who were given hydroxycarbamide in a randomized, double-blind, double-dummy, phase 3b study involving 110 individuals.

Patients were randomized to ruxolitinib 10 mg BID (n=54) or hydroxycarbamide per a prerandomization dose/schedule (n=56). Investigators looked for a ≥50% improvement from baseline to week 16 in total symptom score cytokine symptom cluster (TSS-C; a sum of tiredness, itching, muscle aches, night sweats, and sweats while awake). Among the results:

  • Improvement was achieved by more patients with stable screening-to-baseline TSS-C scores receiving ruxolitinib than hydroxycarbamide (47% vs. 25%).
  • Overall, improvement was achieved by 43% of patients in the ruxolitinib group, vs 30% in those taking hydroxycarbamide (a nonsignificant trend).
  • Ruxolitinib treatment after unblinding was linked with continued symptom score improvements.
  • Adverse events were primarily grades 1/2 with no unexpected safety signals.

Citation:

Mesa R, Vannucchi A, Yacoub A, et al. The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF). [Published online ahead of print November 8, 2016]. Br J Haematol. doi:10.1111/bjh.14382.