Jakafi is a registered trademark of Incyte Corporation.
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2011-2012, Incyte Corporation. All rights reserved.
RUX-1057b 08/12
Symptoms Efficacy
Total Symptom Score (TSS)—objective measure of myelofibrosis symptoms1-4
TSS is derived from a daily diary capturing the symptoms of myelofibrosis4,5 for 25 weeks. Symptom scores ranged from 0 to 10, with 0 representing symptoms "absent" and 10 representing "worst imaginable" symptoms. These scores were added to create the daily total score, which has a maximum of 60.4,5
Core symptoms measured were4
- Abdominal discomfort
- Pain under left ribs
- Night sweats
- Early satiety
- Pruritus
- Bone/muscle pain
Superior improvements in symptoms with Jakafi vs placebo4,5
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COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I).
- Responses in TSS were seen with Jakafi in both JAK2V617F-positive patients and JAK2V617F-negative patients, relative to placebo5
- Median time to response (≥50% reduction in TSS) was <4 weeks4
Jakafi significantly improved Total Symptom Score4,5
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Each bar represents an individual patient's response. Worsening of TSS is truncated at 150%.
COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I).
- Most patients who did not receive Jakafi experienced a worsening of symptoms4
Improvements in all 6 individual symptoms contributed to the TSS4
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COMFORT-I = COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (I).
aJakafi (n = 143); placebo (n = 149).
bJakafi (n = 136); placebo (n = 142).
cJakafi (n = 143); placebo (n = 147).
bJakafi (n = 136); placebo (n = 142).
cJakafi (n = 143); placebo (n = 147).
dJakafi (n = 129); placebo (n = 143).
eJakafi (n = 123); placebo (n = 139).
fJakafi (n = 134); placebo (n = 143).
eJakafi (n = 123); placebo (n = 139).
fJakafi (n = 134); placebo (n = 143).
References:
- Mesa RA, Schwager S, Radia D, et al. The Myelofibrosis Symptom Assessment Form (MFSAF): an evidence-based brief inventory to measure quality of life and symptomatic response to treatment in myelofibrosis. Leuk Res. 2009;33:1199-1203.
- Verstovsek S, Kantarjian H, Mesa RA, et al. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010;363:1117-1127.
- Mesa RA, Kantarjian H, Tefferi A, et al. Evaluating the serial use of the Myelofibrosis Symptom Assessment Form for measuring symptom improvement: performance in 87 myelofibrosis patients on a JAK1 and JAK2 inhibitor (INCB018424) clinical trial. Cancer. 2011;117:4869-4877.
- 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.
- Data on file. Incyte Corporation.
