When PV advances beyond what HU can control, intervene with Jakafi
Ruxolitinib (Jakafi) is a preferred treatment option for patients with high-risk PV who have had an inadequate response or loss of response to cytoreductve therapy2
NCCN=National Comprehensive Cancer Network.
Jakafi is indicated for treatment of PV in adults who have had an inadequate response to or are intolerant of HU.
In the phase 3 RESPONSE* trial, Jakafi demonstrated superior results† vs Best Available Therapy (BAT).1‡
BAT, best available therapy; CI, confidence interval; Hct, hematocrit.
a95% CI, 15%-32%
b95% CI, 0%-5%
cA durability analysis was performed at week 80 in the original Jakafi arm.

76% of patients treated with Jakafi who achieved hematocrit (Hct) control and spleen volume reduction at 32 weeks maintained these responses through 80 weeks (18 months) of treatment.1
*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of hydroxyurea (HU), required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment.1,3
†The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by computed tomography (CT) or magnetic resonance imaging (MRI). To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).1,3
‡BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).1,3

BAT, best available therapy; CI, confidence interval; Hct, hematocrit.
a95% CI, 15%-32%
b95% CI, 0%-5%
cA durability analysis was performed at week 80 in the original Jakafi arm.
76% of patients treated with Jakafi who achieved hematocrit (Hct) control and spleen volume reduction at 32 weeks maintained these responses through 80 weeks (18 months) of treatment.1
Durability of primary response at 5 years
*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of hydroxyurea (HU), required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment.1,3
†The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by computed tomography (CT) or magnetic resonance imaging (MRI). To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).1,3
‡BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).1,3