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RUX-1057e 04/13
Splenomegaly Efficacy of Jakafi
The efficacy and safety of Jakafi® (ruxolitinib) for the treatment of intermediate or high-risk myelofibrosis were studied in 2 phase III clinical trials, COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I (COMFORT-I) and COMFORT-II.
COMFORT-I Trial
Superior reductions in spleen volume with Jakafi vs placebo1,2
- The primary endpoint of COMFORT-I was achieved—a ≥35% reduction in spleen volume
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COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I).
- A similar proportion of patients receiving Jakafi achieved a ≥50% reduction in palpable spleen length1
- Responses in spleen volume reduction were seen with Jakafi in both JAK2V617F-positive patients and JAK2V617F-negative patients, relative to placebo2
Most patients achieved some reduction in spleen volume2
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Each bar represents an individual patient's response.
COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I).
- Most patients who did not receive Jakafi experienced increased splenomegaly1
~32% mean decrease in spleen volume at 24 weeks2
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COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I); SEM = standard error of the mean.
Splenomegaly Efficacy in COMFORT-II
Superior reductions in spleen volume with Jakafi vs best available therapy1,3
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BAT = best available therapy; COMFORT-II = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (II).
- Reductions in spleen volume (in splenomegaly) were seen with Jakafi in both JAK2V617F-positive and JAK2V617F-negative patients3
References:
- Jakafi Prescribing Information. Incyte Corporation. June 2012.
- Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366:799-807.
- Harrison C, Kiladjian JJ, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366:787-798.
