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  1. Safety
  2. Safety Profile in RESPONSE

JAKAVI safety profile in the RESPONSE trial

  • In the RESPONSE trial, safety was a secondary endpoint1
  • 3.6% of patients treated with JAKAVI discontinued due to adverse events2,3*

Haematologic adverse reactions up to Week 322

JAKAVI, a JAK2 inhibitor, helped control multiple key blood counts in Polycythemia Vera patients

Includes new or worsening abnormalities as assessed using laboratory values.2 One patient in the BAT arm withdrew consent and was not treated on study.2

  • The majority of nonhaematologic adverse reactions were Grade 1/22

Nonhaematologic adverse reactions up to Week 322

Nonhaematologic adverse reactions in JAKAVI RESPONSE trial

Includes events occurring in ≥10% of patients in either treatment group.2 One patient in the BAT arm withdrew consent and was not treated on study.2

By Week 32, 1 patient receiving JAKAVI and 6 patients receiving BAT experienced a thromboembolic event2†

Types of thromboembolic events by Week 324,5

Types of thromboembolic events in JAKAVI RESPONSE trial

One patient in the BAT arm withdrew consent and was not treated on study.2 One patient in the BAT arm had both myocardial infarction and pulmonary embolism.5

Next: Dosing recommendations for JAKAVI

*At the time of data cutoff (81 weeks median exposure to therapy in the JAKAVI group).2
†Of 110 and 111 patients in the JAKAVI and BAT arms, respectively.4

BAT=best available therapy; RESPONSE=Randomized Study of Efficacy and Safety in Polycythemia Vera with JAK Inhibitor INCB018424 versus Best Supportive Care.

References:

  1. Data on file. Novartis Pharma AG. Basel, Switzerland.
  2. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372(5):426-435.
  3. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; April 2015.
  4. Vannucchi AM, Kiladjian J-J, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera [supplementary appendix]. N Engl J Med. 2015;372(5):1-25.
  5. Vannucchi AM, Kiladjian J-J, Griesshammer M, et al. Ruxolitinib proves superior to best available therapy in a prospective, randomized, phase 3 study (RESPONSE) in patients with polycythemia vera resistant to or intolerant of hydroxyurea. Paper presented at: 19th Congress of EHA; June 12-15, 2014; Milan, Italy.