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Myelofibrosis symptom control
JAKAVI® (ruxolitinib) 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 full safety information, please refer to the Summary of Product Characteristics.
Study designs: Randomised, controlled trials2,3
Study | Type of study | Regimen | Study purpose and description | Study population |
|---|---|---|---|---|
COMFORT‑I2 | Phase III, double-blind, randomised controlled trial (RCT) | JAKAVI® (n=155) vs placebo (n=154) | Assessment of the efficacy and safety profile of JAKAVI® | Patients with intermediate-2 (int-2) or high-risk myelofibrosis (MF) |
COMFORT‑II3 | Phase III, open-label RCT | JAKAVI® (n=146) vs BAT (n=73) | Assessment of the efficacy and safety profile of JAKAVI® | Patients with int-2 or high-risk MF, post-polycythaemia vera (PV) MF or post-essential thrombocythaemia (ET) MF |
Symptom burden and treatment goals
Patients reported that MF symptoms have a substantial impact on their daily life4–7
Patients with MF (n=174) regularly cancel plans, miss work and feel depressed or anxious4–7
83% of patients report reduced quality of life (QoL) due to MF symptoms*4
45% reported missing work in the previous week (average of 4.8 hrs)*†4
61% of MPN patients report feeling depressed in the previous month*4
59% of patients believed they often felt worse than their healthcare professional realised*4
The International MPN Landmark Survey was developed and funded by Novartis.
Maintenance of QoL is one of the main goals of MF treatment in the non-transplant setting according to the BSH guidelines8
Which treatment goals are most important to your patients?
International MPN Landmark Survey: most important treatment goals in MF‡4
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Adapted from Harrison CN, et al. 2017.4
Symptom control in the COMFORT-I and COMFORT-II trials
JAKAVI® may help patients reach their goal of improved symptom control from baseline2,3,9
COMFORT-I: proportion of patients with ≥50% reduction in total symptom score (TSS) over time (secondary endpoint)2
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Adapted from Verstovsek S, et al. 2012.2
Assessed by the modified Myelofibrosis Symptom Assessment Form (MF-SAF) in a double-blind, Phase III RCT (intent-to-treat analysis)*§2
At Week 24, significantly more patients achieved symptom improvement with JAKAVI® vs placebo from baseline (p<0.001)2
COMFORT-II: mean change from baseline in EORTC QLQ-C30 symptom scores to Week 48 in a double-blind, Phase III RCT (prespecified exploratory endpoint)3
Fatigue
−12.8% with JAKAVI® vs +0.4% with BAT
Dyspnoea
−6.3% with JAKAVI® vs +4.8% with BAT
Appetite loss
−8.2 with JAKAVI® vs +9.5% with BAT
Pain
−1.9% with JAKAVI® vs +3.0% with BAT
Insomnia
−12.3% with JAKAVI® vs +6.0% with BAT
Negative scores indicate a decrease in symptoms; p-values were not reported.
Decreases in MF-related symptoms were observed with JAKAVI® vs an increase of symptoms with BAT3
The most frequently reported haematological adverse drug reactions included anaemia (83.8%), thrombocytopenia (80.5%) and neutropenia (20.8%). The three most frequent non-haematological adverse drug reactions were bruising (33.3%), other bleeding (including epistaxis, post-procedural haemorrhage and haematuria) (24.3%) and dizziness (21.9%).1 Please refer to the SmPC for more information.
To learn more about the efficacy of JAKAVI® in splenomegaly, click here
To learn more about the overall survival data with JAKAVI®, click here
*Data from patients with MF (n=174, including 45 UK patients) in the international MPN Landmark Survey (N=699, including 286 UK patients).4
†MF patients in full- or part-time employment at the time of the survey.4
‡Patients and physicians were asked to assign rankings for their top three treatment goals. Patients were asked: Other than a cure for your condition, what are your three most important treatment goals? Physicians were asked: Other than a cure, what is your most important treatment goal for therapy?4
§Improvements in symptoms were observed in patients treated with JAKAVI® at Week 4, maintained to Week 24; the primary endpoint was the proportion of patients with an SVR35 at Week 24. Each value plotted represents the moving average for the previous 7 days. Shortened 7-item modified MF-SAF form used, covering night sweats, itching, abdominal discomfort, pain under the ribs on the left side, early satiety, muscle/bone pain and inactivity.2
BAT, best available therapy; BSH, British Society for Haemtaology; CI, confidence interval; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; int-2, intermediate-2; MF, myelofibrosis; MF-SAF, myelofibrosis symptom assessment form; MPN, myeloproliferative neoplasm; OR, odds ratio; PV, polycythaemia vera; QoL, quality of life; RCT, randomised controlled trial; SVR35, ≥35% spleen volume reduction; TSS, total symptom score.
References
JAKAVI® (ruxolitinib) Summary of Product Characteristics.
Verstovsek S, et al. N Engl J Med 2012;366:799–807 and supplementary appendix.
Harrison C, et al. N Engl J Med 2012;366:787–798.
Harrison CN, et al. Ann Hematol 2017;96:1653–1665.
Petruk C and Mathias J. Adv Ther 2020;37:2050–2070.
Brochmann N, et al. Clin Epidemiol 2019;11:23–33.
Yu J, et al. BMC Cancer 2018;18:420–424.
McLornan DP, et al. Br H Haematol 2024;204:136–150.
Mesa R, et al. J Clin Oncol 2017;35:3844–3850.
UK | September 2025 | FA-11448876
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.
