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Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review

Kartik Anand1, Ethan A Burns2, Joe Ensor1

  • 1Houston Methodist Cancer Center/Weill Cornell Medicine, Houston, TX.

Clinical Lymphoma, Myeloma & Leukemia
|November 9, 2019
PubMed
Abstract

Insights

Ruxolitinib treatment increases the risk of developing Mycobacterium tuberculosis (MTB) and atypical mycobacterial infections (AMI). Healthcare providers should screen patients for latent MTB before starting ruxolitinib therapy.

Area of Science:

  • Pharmacology
  • Infectious Diseases
  • Hematology

Background:

  • Ruxolitinib, a Janus kinase (JAK) 1/2 inhibitor, is approved for myelofibrosis (MF) and polycythemia vera (PV).
  • Patients with MF and PV treated with ruxolitinib may be susceptible to opportunistic infections.
  • Mycobacterial infections, including typical (Mycobacterium tuberculosis [MTB]) and atypical (AMI), are potential risks.

Purpose of the Study:

  • To assess the incidence of MTB and AMI in patients treated with ruxolitinib.
  • To evaluate the association between ruxolitinib use and mycobacterial infections using pharmacovigilance data.

Main Methods:

  • Retrospective analysis of the FDA Adverse Events Reporting System (FAERS) database.
  • Querying FAERS for MTB and AMI cases linked to ruxolitinib from January 1, 2011, to December 31, 2018.
  • Disproportionality signal analysis using Reporting Odds Ratio (ROR) with a significant threshold of ROR lower limit of 95% CI > 1.

Main Results:

  • A significant increase in reported MTB cases associated with ruxolitinib (ROR = 9.2; 95% CI, 7.5-11.4).
  • A significant increase in reported AMI cases associated with ruxolitinib (ROR = 8.3; 95% CI, 5.5-12.6).
  • Mortality rates were 13.2% for MTB and 34.8% for AMI among affected patients.

Conclusions:

  • Ruxolitinib therapy is associated with an elevated risk of developing both MTB and AMI.
  • Clinicians should consider screening for latent MTB before initiating ruxolitinib treatment.
  • Awareness of these risks is crucial for managing patients on ruxolitinib.
Keywords:
Atypical mycobacterial infectionMycobacterium tuberculosisMyelofibrosisPolycythemia veraTuberculosis

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