JAKAVI (ruxolitinib) was studied in the first and most comprehensive clinical trial program in myelofibrosis to date1,2


  • COMFORT-I and COMFORT-II were pivotal Phase III trials1,2
  • JAKAVI was studied on more than 500 patients with myelofibrosis worldwide1,2

COMFORT-I

COMFORT-I demonstrated that JAKAVI produces a significant reduction in spleen volume1

JAKAVI, "as compared with placebo, provided significant clinical benefits in patients with myelofibrosis by reducing spleen size [and] ameliorating debilitating myelofibrosis-related symptoms."1

COMFORT is an acronym for COntrolled MyeloFibrosis Study with ORal Janus-associated (JAK) Inhibitor Treatment.1

  • The randomised, double-blind, placebo-controlled, phase III trial was conducted at 89 sites in the United States, Canada, and Australia1
  • Study duration was 24 weeks1
  • Study eligibility requirements included patients:
    • being 18 years of age or older
    • having primary myelofibrosis, post-polychthaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis, according to 2008 World Health Organization criteria
    • having a life expectancy of 6 months or longer, according to the International Prognosis Scoring System


Primary endpoint: Proportion of patients achieving a ≥35% reduction in spleen volume at Week 24 (as measured by MRI or CT Scan)1

Secondary endpoints included1

  • Duration of maintenance of a ≥35% reduction in spleen volume
  • Proportion of patients who had a ≥50% reduction from baseline at Week 24 in Total Symptom Score (TSS) as measured by the modified MFSAF v2.0 diary
  • Change from baseline to Week 24 in TSS as measured by the modified MSFAF v2.0 diary
Reference
  1. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.

COMFORT-II

COMFORT-II — a phase III study — confirms efficacy of JAKAVI in treatment of MF1

  • Durability of improvements in symptoms and splenomegaly demonstrated to 48 weeks1

"...The meaningful overall reductions in debilitating symptoms of myelofibrosis and improvements in role functioning, which were observed by Week 8 and continued through Week 48, attest to the beneficial effects of ruxolitinib on quality of life for patients with myelofibrosis..."1

COMFORT is an acronym for COntrolled MyeloFibrosis Study with ORal Janus-associated (JAK) Inhibitor Treatment.1

  • Patients were randomly assigned, in a 2:1 ratio, to receive ruxolitinib or the best available therapy, which included any commercially available agents (as monotherapy or in combination) or no therapy at all, and which could be changed during the treatment phase1
  • Study duration was 48 weeks1
  • Study eligibility requirements included patients:
    • being 18 years of age or older
    • having primary myelofibrosis, post-polychthaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis
    • having a spleen length 5 cm or more below the coastal margin, irrespective of JAK2V617F mutation status1

Superiority of JAKAVI to Best Available Therapy (BAT)

  • Real-world comparator included 47% of patients taking hydroxyurea1

Primary endpoint: Proportion of patients achieving a ≥35% reduction in spleen volume at Week 48 (as measured by MRI or CT Scan)1

Secondary endpoints included1

  • Proportion of patients achieving a ≥35% reduction in spleen volume at Week 24
  • Duration of maintenance of a ≥35% reduction from baseline in spleen volume
  • Change from baseline to Week 24 in TSS as measured by the modified MSFAF v2.0 diary
Reference
  1. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Eng J Med. 2012;366(9):787-798.
References
  1. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  2. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  3. JAKAVI [Summary of Product Characteristics]. Basel, Switzerland: Novartis Pharma AG; 2013.

Quality of life

Myelofibrosis can have a significant impact on quality of life1

More

Splenomegaly reduction

Read about the significant reductions in splenomegaly1,2

More

Safety

JAKAVI has a well-characterised safety profile3

More

Learn more about:

> JAKAVI Safety Profile

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COMFORT-I: Randomised, double-blind, placebo-controlled
Phase III study1

RANDOMISATION (1:1)

  • Patients with MF
    (n=309)
  • JAKAVI
    15mg or 20 mg bid depending on platelet count
  • Placebo Bid

Bid=twice daily.
Patients with MF=those primary MF, post-polycythaemia vera MF, or post-essential thrombocythaemia MF.

COMFORT-II: Open –label, randomised Phase III study vs BAT 1

RANDOMISATION (2:1)

  • Patients with MF
    (n=309)
  • JAKAVI
    15mg or 20 mg bid depending on platelet count
  • Best available therapy

Bid=twice daily.
BAT included any single treatment or combination of treatments ( such as hydroxyurea [47%], glucocorticoids [16%], or no drug treatment [33%]