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).
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| Abstract |
The randomized, double-blind, double-dummy, phase 3b RELIEF trial evaluated polycythaemia vera (PV)-related symptoms in patients who were well controlled with a stable dose of hydroxycarbamide (also termed hydroxyurea) but reported PV-related symptoms. Patients were randomized 1:1 to ruxolitinib 10 mg BID (n = 54) or hydroxycarbamide (prerandomization dose/schedule; n = 56); crossover to ruxolitinib was permitted after Week 16. The primary endpoint, ≥50% improvement from baseline in myeloproliferative neoplasm -symptom assessment form total symptom score cytokine symptom cluster (TSS-C; sum of tiredness, itching, muscle aches, night sweats, and sweats while awake) at Week 16, was achieved by 43·4% vs. 29·6% of ruxolitinib- and hydroxycarbamide-treated patients, respectively (odds ratio, 1·82; 95% confidence interval, 0·82-4·04; P = 0·139). The primary endpoint was achieved by 34% of a subgroup who maintained their hydroxycarbamide dose from baseline to Weeks 13-16. In a post hoc analysis, the primary endpoint was achieved by more patients with stable screening-to-baseline TSS-C scores (ratio ≤ 2) receiving ruxolitinib than hydroxycarbamide (47·4% vs. 25·0%; P = 0·0346). Ruxolitinib treatment after unblinding was associated with continued symptom score improvements. Adverse events were primarily grades 1/2 with no unexpected safety signals. Ruxolitinib was associated with a nonsignificant trend towards improved PV-related symptoms versus hydroxycarbamide, although an unexpectedly large proportion of patients who maintained their hydroxycarbamide dose reported symptom improvement.
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| Authors | Ruben Mesa, Alessandro M Vannucchi, Abdulraheem Yacoub, Pierre Zachee, Mamta Garg, Roger Lyons, Steffen Koschmieder, Ciro Rinaldi, Jennifer Byrne, Yasmin Hasan, Francesco Passamonti, Srdan Verstovsek, Deborah Hunter, Mark M Jones, Huiling Zhen, Dany Habr, Bruno Martino |
| Journal | British journal of haematology (Br J Haematol) Vol. 176 Issue 1 Pg. 76-85 (Jan 2017) ISSN: 1365-2141 [Electronic] England |
| PMID | 27858987 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial) |
| Copyright | © 2016 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd. |
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