RESPONSE-2
RESPONSE-2 extended ruxolitinib's benefit to PV patients without an enlarged spleen: three times as many reached haematocrit control.
Overview
RESPONSE-2 randomised 149 patients with hydroxyurea-resistant or intolerant PV and no palpable spleen to ruxolitinib or best available therapy. Haematocrit control at week 28, the primary endpoint, was achieved by 62 percent on ruxolitinib versus 19 percent on best available therapy (Passamonti and colleagues, Lancet Oncology 2017), with better symptom scores.
- 62 vs 19 out of 100 reached this endpoint with Ruxolitinib compared with Best available therapy; 43 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Hydroxyurea-resistant or intolerant polycythaemia vera without splenomegaly: ruxolitinib versus best available therapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
149 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Haematocrit control at week 28primary | Ruxolitinib | 74 | 62% | - | - | - |
| Best available therapy | 75 | 19% |
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