Inhibit the JAK pathway* in polycythemia
vera not controlled with hydroxyurea
1-3
Jakafi® (ruxolitinib) is the first and only FDA-approved treatment for patients
who have had an inadequate response to or are intolerant of hydroxyurea3
Jakafi demonstrated superior
results in a phase 3 trial vs best
available therapy3,4†
Primary Response at Week 323,4
80
* Ruxolitinib, a kinase inhibitor, inhibits JAK1 and JAK2
(Janus-associated kinases 1 and 2), which mediate the
signaling of cytokines and growth factors important for
hematopoiesis and immune function.3
A randomized, open-label, active-controlled phase 3 trial
comparing Jakafi with best available therapy (BAT) in
222 patients. Best available therapy included hydroxyurea
(60%), interferon/pegylated interferon (12%), anagrelide
(7%), pipobroman (2%), lenalidomide/thalidomide (5%),
and observation (15%). Patients had been diagnosed with
polycythemia vera for at least 24 weeks, had an inadequate
response to or were intolerant of hydroxyurea, required
phlebotomy, and exhibited splenomegaly. The primary end
point was the proportion of subjects achieving a response
at week 32, with response defined as having achieved
both hematocrit (Hct) control (the absence of phlebotomy
eligibility beginning at the week 8 visit and continuing
through week 32) and spleen volume reduction (a ≥35%
reduction from baseline in spleen volume at week 32).
Phlebotomy eligibility was defined as Hct >45% that is
≥3 percentage points higher than baseline or Hct >48%
(lower value).3,4
P < 0.0001
Jakafi (n = 110)
BAT (n = 112)
(n = 66)
38%
40
21%
a
20
0
a
Individual Components of
Primary End Point
60%
60
Patients (%)
†
Composite
Primary End Point
(n = 23)
1%b
(n = 22)
(n = 1)
Hct Control +
Spleen Volume
Reduction
95% CI, 14%-30%
When discontinuing Jakafi, myeloproliferative neoplasmrelated symptoms may return within one week. After
discontinuation, some patients with myelofibrosi ́