Ruxolitinib

(Jakafi®)

Ruxolitinib

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Drug updated on 4/10/2024

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

Indication

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

Summary
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  • Ruxolitinib (Jakafi) is a selective inhibitor of Janus Kinase 1 and 2, used for treating myelofibrosis, polycythemia vera, and steroid-refractory acute and chronic graft-versus-host disease in both adult and pediatric patients aged 12 years or older.
  • Analysis was based on 11 systematic reviews/meta-analyses concerning Ruxolitinib.
  • In the treatment of steroid-refractory graft-versus-host disease (SR-GvHD), Ruxolitinib showed promising effectiveness with an overall response rate ranging from 45% to100%, yielding significant results compared to other second-line therapies such as mesenchymal stroma cell addition or inolimomab.
  • For myelofibrosis treatment, earlier initiation of Ruxolitinib post-diagnosis resulted in improved overall survival rates, fewer cytopenia events, durable spleen volume response (SVR), making it more effective than placebo or the best available therapy.
  • When comparing different Janus kinase inhibitors for myelofibrosis treatment, like fedratinib and momelotinib; efficacy-wise, they were comparable, but side effect profiles varied, which might guide the choice between them.
  • In treating polycythemia vera patients who are intolerant or have had an inadequate response to hydroxyurea, thrombosis reduction favored Ruxolitinib over the best available therapy, although differences did not reach statistically significant levels. It also improved quality-of-life outcomes compared to conventional treatments.
  • The safety profile involves considerations for treatment-related toxicities, including cytopenia, liver toxicity, and infections. Ruxolitinib has been associated with increased risks of specific infections, notably herpes zoster, in the context of Myeloproliferative neoplasm (MPN) patients. However, the safety profile is deemed manageable and comparable to other options.
  • Ruxolitinib's advantages over other treatments include improved response rates and clinical outcomes, particularly for SR-GvHD and myelofibrosis. It offers an essential therapeutic choice for patients who have limited options due to resistance or intolerance to other therapies but requires careful monitoring for specific side effects, including increased risks of infections and cytopenia.

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