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JAKAVI® (ruxolitinib) in myelofibrosis
JAKAVI® is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. JAKAVI® is also indicated for adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.1
For your eligible myelofibrosis patients with disease-related splenomegaly or symptoms1–6
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Treatment with JAKAVI® can help reduce:
spleen size vs BAT: 28% of patients treated with JAKAVI® (n=41/144) achieved at least a 35% reduction in spleen volume at Week 48 compared to 0% of patients treated with BAT (n=0/72) (p<0.001, primary endpoint)*7
symptom burden vs placebo: 45.9% of patients treated with JAKAVI® (n=68/149) achieved an improvement of 50% or more in the total symptom score from baseline to Week 24 compared to 5.3% of patients treated with placebo (n=8/152) (OR=15.3; 95% CI: 6.9–33.7; p<0.001) (prespecified secondary endpoint)†6
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Recommended by the BSH guidelines as a treatment option and reimbursed across the UK in eligible patients2,8,9
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In an exploratory analysis, long-term treatment with JAKAVI® was associated with prolonged survival vs control10
In an analysis of 5-year pooled data from the COMFORT studies, the risk of death (exploratory endpoint) was reduced by 30% in patients randomised to JAKAVI® (n=301) vs control (n=227, placebo in COMFORT-I, BAT in COMFORT-II); median OS (JAKAVI® vs control), 5.3 vs 3.8 years (HR, 0.70; 95% CI, 0.54–0.91; p=0.0065)10
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Well-characterised safety profile.1 For more information about the safety profile of JAKAVI® in MF, please click here
Footnotes & references
*Spleen volume was assessed by MRI, or by CT for patients in whom MRI was contraindicated or in facilities where MRI was not readily available. Spleen length was assessed by manual palpation at every study visit using a soft centimetre ruler from the costal margin to the point of greatest splenic protrusion.6,7
†COMFORT-I: randomised, double-blind, Phase III trial comparing efficacy and safety of JAKAVI® (n=155) with placebo (n=154) in patients with intermediate-2 or high-risk MF. 41.9% of patients in the JAKAVI® group achieved a reduction in spleen volume of 35% or more at Week 24 (primary endpoint) vs with 0.7% in the placebo group (OR=134.4; 95% CI: 18.0–1004.9, p<0.001).6 COMFORT-II: randomised Phase III trial comparing JAKAVI® (n=146) with BAT (n=73, any commercially available agents as monotherapy or in combination, or no therapy at all) in patients with primary MF, post-PV MF or post-ET MF. In prespecified exploratory analyses of patient reported outcomes (as assessed by means of the EORTC QLQ-C30 and FACT-Lym subscales), improvements in quality-of-life and role functioning scores were observed in patients who received JAKAVI®, compared to patients who received BAT; no statistical analyses were conducted. At Week 48, patients receiving JAKAVI® had marked reductions in myelofibrosis-associated symptoms, including appetite loss, dyspnoea, fatigue, insomnia and pain, whereas patients receiving the best available therapy had worsening symptoms.7
BAT, best available therapy; BSH, British Society for Haematology; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; ET, essential thrombocythaemia; FACT-Lym, The Functional Assessment of Cancer Therapy-Lymphoma; HR, hazard ratio; JAK, janus kinase; MF, myelofibrosis; MRI, magnetic resonance imaging; OR, odds ratio; OS, overall survival.
References
JAKAVI® (ruxolitinib) Summary of Product Characteristics.
Scottish Medicines Consortium. Ruxolitinib (Jakavi®). Available at: https://scottishmedicines.org.uk/medicines-advice/ruxolitinib-jakavi-full-smc2213/ [Accessed November 2024].
Vannucchi AM, et al. N Engl J Med 2015;372:426–435.
Verstovsek S, et al. Haematologica 2016;101:821–829.
Griesshammer M, et al. Ann Hematol 2018;97:1591–1600 and supplementary appendix.
Verstovsek S, et al. N Engl J Med 2012;366:799–807.
Harrison C, et al. N Engl J Med 2012;366:787–798.
Reilly J, et al. Br J Haematol 2014;167:418–438.
National Institute for Health and Care Excellence. Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis [TA386]. Available at: https://www.nice.org.uk/guidance/ta386. [Accessed November 2024].
Verstovsek S, et al. J Hematol Oncol 2017;10:156.
UK | November 2024 | FA-11208694
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
