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The results from the phase III trial RESPONSE (NCT01243944) led to ruxolitinib's approval for patients with polycythemia vera (PV) that showed resistance or intolerance to hydroxyurea. Treatment with ruxolitinib for 8 weeks achieved a hematocrit control without phlebotomy and a ≥ 35% reduction in spleen size in 20.9% of patients, significantly improving the results reported with the alternative therapies. After a 5-year follow-up, 70% of patients who initially benefited from ruxolitinib, maintained their response. Moreover, patients experienced fewer thromboembolic events and lower rates of serious AEs when compared with the best available treatment.1
To further confirm the positive results of ruxolitinib in this setting in the real-world clinical practice and unselected patient population, Peter AW te Boekhorst, Erasmus Medical Center, NL, gathered the experience from 88 hospitals across Europe. Here, we summarize the key findings of the 52-week interim analysis presented at the 25th European Hematology Association (EHA) Virtual Congress.2
Table 1. Baseline patient characteristics2
HU, hydroxyurea *Data available from 55 patients †Data available from 22 patients |
|
Characteristic |
N = 60 patients |
---|---|
Age, > 60 years, % |
65 |
HU resistant, % |
65.5 |
HU intolerant, % |
61.7 |
Active infection, % |
18 |
Secondary neoplasms, % |
10 |
Thromboembolic events, % |
17 |
Hematocrit*, % |
|
< 40% |
10.9 |
≥ 40 – ≤ 45% |
45.1 |
> 45% |
43.6 |
Splenomegaly†, % |
|
No enlargement (0 cm) |
50 |
Mild (< 4 cm) |
13.6 |
Moderate (4–8 cm) |
18.2 |
Massive (> 8 cm) |
18.2 |
Phlebotomy-independent patients, % |
38 |
Table 2. Severe adverse events reported during the study2
Grade 3–4 adverse events |
Incidence, % (N = 60 patients) |
---|---|
Infections |
5 |
Hypertension |
5 |
Thromboembolic events |
3 |
Secondary neoplasms |
2 |
The preliminary results of this observational study support the reported study results of ruxolitinib in patients with PV. Patients achieved hematocrit control, reduced the dependence on phlebotomies, and maintained or even reduced the spleen size during the first year of continuous treatment. This study is ongoing and will further describe ruxolitinib's role in PV management once the data from all 352 patients will be available.
References
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