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Haematologic reactions are expected and manageable1

Anaemia and thrombocytopenia are expected adverse reactions associated with JAKAVI therapy, based on the mechanism of action1

  • JAK signalling plays an important role in haematopoiesis by mediating the activity of growth factors, including EPO and TPO2
  • Anaemia and thrombocytopenia are expected consequences of JAK inhibition because erythropoietin and thrombopoietin signal through JAK22
  • Anaemia and thrombocytopenia were the most common adverse reactions during JAKAVI therapy; however, they rarely led to treatment discontinuation1,3
    • 2 patients (1%) discontinued treatment due to anaemia1
    • 7 patients (3.6%) discontinued treatment due to thrombocytopaenia1

Percentage of MF patients treated with JAKAVI with haematologic adverse reactions3,a

Anemia and thrombocytopenia are expected adverse reactions associated with JAKAVI therapy, based on the mechanism of action1

aAll MF patients (n=301) randomised to and treated with JAKAVI from COMFORT-I and COMFORT-II.
bCTCAE version 3.0; Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening.

  • Incidence of Grade 3 or 4 anaemia and thrombocytopenia typically present early in the treatment course with JAKAVI (≤6 months) and decreased with long-term therapy1

Anaemia gradually recovered to reach a new steady state that was approximately 5 g/L below baseline and was manageable1,3

Haemoglobin levels over time1

Haemoglobin levels over time - JAKAVI

Adapted from: Cervantes F et al. Blood. 2013;122:4047-4053.1
JAKAVI included both randomised and extension phases; BAT included randomised phase only and did not include assessments after crossover.

  • Haemoglobin levels generally decrease after starting JAKAVI therapy, reaching a nadir after 8 to 12 weeks of therapy and thereafter gradually recovering to reach a new steady state that was approximately 5 g/L below baseline1,3

Thrombocytopenia was generally reversible and manageable3

Platelet counts over time1

Platelet counts over time - JAKAVI

Adapted from: Cervantes F et al. Blood. 2013;122:4047-4053.1
JAKAVI included both randomised and extension phases; BAT included randomised phase only and did not include assessments after crossover.

  • Median onset of Grade 3/4 thrombocytopenia was 8 weeks, and median time to recovery of platelet counts above 50,000/mm3 was 14 days3
Cytopenias associated with JAKAVI therapy were successfully managed with dose titration and appropriate supportive care1,3

Next: Individualised starting dose based on platelet count

COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CTCAE=Common Terminology Criteria for Adverse Events; EPO=erythropoietin; JAK=Janus kinase; TPO=thrombopoietin.

References:

  1. Cervantes F, Vannucchi AM, Kiladjian J-J, et al; for the COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013;122(25):4047-4053.
  2. Quintas-Cardama A, Vaddi K, Liu P, et al. Preclinical characterization of the selective JAK 1/2 inhibitor INCB018424: therapeutic implications for the treatment of myeloproliferative neoplasms. Blood. 2010;115(15):3109-3117.
  3. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; May 2017.