For US Healthcare Professionals Only
For US Healthcare Professionals Only
In the phase 3 RESPONSE* trial, Jakafi demonstrated superior results† vs BAT1‡
(25/110) of patients receiving Jakafi achieved Hct control and ≥35% spleen volume
reduction at week 32 vs <1% (1/112) of patients receiving BAT (P<0.0001)1§
For me, even 45.1% isn’t good enough and any hematocrit level above 45% needs action. I believe the time that my patient spends with hematocrit above 45% and every time they need a phlebotomy, or a dose increase in hydroxyurea, that’s the same amount of time they potentially spend at risk of a thrombotic event.
HEAR FROM DR HARRISON ABOUT HCT CONTROL AND THROMBOSIS-FREE SURVIVALIndividual component of the primary endpoint
More patients achieved Hct control with Jakafi in the absence of phlebotomy eligibility
In the RESPONSE trial, patients on Jakafi achieved a higher rate of Hct control vs BAT1
(66/110) of patients receiving Jakafi achieved Hct control at week 32 vs 19% (21/112) of patients receiving BAT1
*The RESPONSE 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 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 on BAT were able to cross over to Jakafi treatment.1,4
†The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or 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).1,4
‡BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).1
§Jakafi: 95% CI, 0.15-0.32; BAT: 95% CI, 0.00-0.05.1
BAT=best available therapy; CI=confidence interval; CT=computed tomography; Hct=hematocrit; HU=hydroxyurea; MF=myelofibrosis; MRI=magnetic resonance imaging; PV=polycythemia vera; RESPONSE=Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care; WBC=white blood cell.
References: 1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation. 2. Kiladjian J-J, Zachee P, Hino M, et al. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. 2020;7(3):e226-e237. Supplementary appendix available at: doi:10.1016/S2352-3026(19)30207-8. 3. Data on file. Incyte Corporation. Wilmington, DE. 4. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372(5):426-435. Supplementary appendix available at: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1409002/suppl_file/nejmoa1409002_appendix.pdf.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.