Ruxolitinib

(Jakafi®)

Ruxolitinib

Drug updated on 9/4/2024

Dosage FormTablet (oral; 5 mg, 10 mg, 15 mg, 20 mg, 25 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
  • Indicated for treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
  • Indicated for treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
  • Indicated for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Latest News

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Summary
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  • Jakafi (ruxolitinib) is indicated for the treatment of intermediate or high-risk myelofibrosis, including primary, post-polycythemia vera, and post-essential thrombocythemia myelofibrosis in adults. It is also used for treating polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. Additionally, Jakafi is indicated for the treatment of steroid-refractory acute graft-versus-host disease and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in patients 12 years and older.
  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • Ruxolitinib demonstrated superior efficacy in steroid-refractory acute GvHD, showing higher overall and complete response rates, improved durable responses, and longer failure-free survival compared to other treatments.
  • In myelofibrosis, earlier initiation of ruxolitinib was associated with better spleen volume response rates and improved overall survival.
  • For steroid-refractory GvHD in the general population, the overall response rates were 77% for acute and 78% for chronic, with the highest response observed in oral manifestations.
  • Pediatric Population with SR-GvHD: Treatment-related toxicities occurred in 20% of patients, with increased incidence of cytopenia, liver toxicity, and infections; higher toxicity rates were observed in acute GvHD (aGvHD) patients.
  • General Population with SR-GvHD: Common adverse events included cytopenia and infections, with infection rates comparable between children and adults.
  • Myelofibrosis (MF): Increased risk of herpes zoster infection was noted, with odds ratios of 7.39 and 5.23 for early and extension phases, respectively; fewer thrombocytopenia and anemia events were reported in patients who started ruxolitinib earlier.
  • Pediatric patients with SR-GvHD experienced higher treatment-related toxicities, adults with myelofibrosis showed improved outcomes with earlier initiation of ruxolitinib, and various efficacy and safety profiles were noted among different JAK inhibitors for myelofibrosis.

Product Monograph / Prescribing Information

Document TitleYearSource
Jakafi (ruxolitinib) Prescribing Information.2023Incyte Corporation, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Ruxolitinib for the treatment of acute and chronic graft-versus-host disease in children: A systematic review and individual patient data meta-analysis.2024Bone marrow transplantation
Second-line therapy for patients with steroid-refractory aGVHD: Systematic review and meta-analysis of randomized controlled trials.2023Frontiers in Immunology
Early intervention in myelofibrosis and impact on outcomes: a pooled analysis of the COMFORT-I and COMFORT-II studies.2023Cancer
Efficacy and safety of ruxolitinib for steroid-refractory graft-versus-host disease: Systematic review and meta-analysis of randomised and non-randomised studies.2022PLoS ONE
Efficacy and safety of ruxolitinib in steroid-refractory graft-versus-host disease: a meta-analysis.2022Frontiers in Immunology
Chronic graft-versus-host disease presenting as acute polymyositis: a case series and systematic review.2022Transplant Immunology
Effects of ruxolitinib on infection in patients with myeloproliferative neoplasm: a meta-analysis.2021Hematology
Efficacy and tolerability of Janus kinase inhibitors in myelofibrosis: a systematic review and network meta-analysis.2021Blood Cancer Journal
Ruxolitinib for treatment of steroid-refractory graft-versus-host disease in adults: a systematic review and meta-analysis.2020Expert Review of Hematology
Ruxolitinib for the prevention of thrombosis in polycythemia vera: a systematic review and meta-analysis.2020Blood Advances
Ruxolitinib in the treatment of polycythemia vera: an update on health-related quality of life and patient-reported outcomes.2019Journal of Blood Medicine

Clinical Practice Guidelines