Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review

Research output: Contribution to journalArticle

Kartik Anand, Ethan A. Burns, Joe Edward Ensor, Jr., Lawrence Rice, Sai Ravi Pingali

Background: Ruxolitinib is a selective Janus kinase inhibitor (JAKI) 1/2 approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). These patients may be at risk for developing opportunistic infections. We assessed the number of patients that developed typical (Mycobacterium tuberculosis [MTB]) and atypical mycobacterial infections (AMI) while on treatment with ruxolitinib by utilizing the United States Food and Drug Administration (FDA) adverse events reporting system (FAERS). Materials and Methods: This is a retrospective study utilizing FAERS, a pharmacovigilance database. We queried FAERS for cases of MTB and AMI secondary to ruxolitinib between January 1, 2011 and December 31, 2018. Disproportionality signal analysis was done by calculating the reporting odds ratio (ROR). ROR was considered significant when the lower limit of 95% confidence interval (CI) was > 1. Results: There were 91 reported cases of MTB associated with ruxolitinib compared with 4575 cases from all other drugs. The ROR was significant at 9.2 (95% CI, 7.5-11.4). There were 23 reports of AMI with ruxolitinib compared with 1287 reported with all other drugs. The ROR was significant at 8.3 (95% CI, 5.5-12.6). Twelve (13.2%) patients with MTB and 8 (34.8%) with AMI died. Conclusion: Patients on ruxolitinib are at increased risk of developing MTB and AMI. Clinicians should be aware of this risk and consider screening patients for latent MTB prior to initiating ruxolitinib. Patients on ruxolitinib may be predisposed to mycobacterial infections. This observational, retrospective, pharmacovigilance study used the United States Food and Drug Administration adverse events reporting system to compare the number of patients that developed typical and atypical mycobacterial infections to all drugs in the system. Using the reporting odds ratio (ROR), there is an increased risk of developing tuberculosis (ROR, 9.2; 95% confidence interval, 7.5-11.4) and atypical mycobacterial infections (ROR, 8.3; 95% confidence interval, 5.5-12.6) while on treatment with ruxolitinib.

Original languageEnglish (US)
Pages (from-to)18-23
Number of pages6
JournalClinical Lymphoma, Myeloma and Leukemia
Volume20
Issue number1
DOIs
StatePublished - Jan 1 2020

PMID: 31699655

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Mycobacterial Infections With Ruxolitinib : A Retrospective Pharmacovigilance Review. / Anand, Kartik; Burns, Ethan A.; Ensor, Jr., Joe Edward; Rice, Lawrence; Pingali, Sai Ravi.

In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 20, No. 1, 01.01.2020, p. 18-23.

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Harvard

Anand, K, Burns, EA, Ensor, Jr., JE, Rice, L & Pingali, SR 2020, 'Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review' Clinical Lymphoma, Myeloma and Leukemia, vol. 20, no. 1, pp. 18-23. https://doi.org/10.1016/j.clml.2019.08.008

APA

Anand, K., Burns, E. A., Ensor, Jr., J. E., Rice, L., & Pingali, S. R. (2020). Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review. Clinical Lymphoma, Myeloma and Leukemia, 20(1), 18-23. https://doi.org/10.1016/j.clml.2019.08.008

Vancouver

Anand K, Burns EA, Ensor, Jr. JE, Rice L, Pingali SR. Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review. Clinical Lymphoma, Myeloma and Leukemia. 2020 Jan 1;20(1):18-23. https://doi.org/10.1016/j.clml.2019.08.008

Author

Anand, Kartik ; Burns, Ethan A. ; Ensor, Jr., Joe Edward ; Rice, Lawrence ; Pingali, Sai Ravi. / Mycobacterial Infections With Ruxolitinib : A Retrospective Pharmacovigilance Review. In: Clinical Lymphoma, Myeloma and Leukemia. 2020 ; Vol. 20, No. 1. pp. 18-23.

BibTeX

@article{3177a1af92424a5e8c1d6657ba613087,
title = "Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review",
abstract = "Background: Ruxolitinib is a selective Janus kinase inhibitor (JAKI) 1/2 approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). These patients may be at risk for developing opportunistic infections. We assessed the number of patients that developed typical (Mycobacterium tuberculosis [MTB]) and atypical mycobacterial infections (AMI) while on treatment with ruxolitinib by utilizing the United States Food and Drug Administration (FDA) adverse events reporting system (FAERS). Materials and Methods: This is a retrospective study utilizing FAERS, a pharmacovigilance database. We queried FAERS for cases of MTB and AMI secondary to ruxolitinib between January 1, 2011 and December 31, 2018. Disproportionality signal analysis was done by calculating the reporting odds ratio (ROR). ROR was considered significant when the lower limit of 95{\%} confidence interval (CI) was > 1. Results: There were 91 reported cases of MTB associated with ruxolitinib compared with 4575 cases from all other drugs. The ROR was significant at 9.2 (95{\%} CI, 7.5-11.4). There were 23 reports of AMI with ruxolitinib compared with 1287 reported with all other drugs. The ROR was significant at 8.3 (95{\%} CI, 5.5-12.6). Twelve (13.2{\%}) patients with MTB and 8 (34.8{\%}) with AMI died. Conclusion: Patients on ruxolitinib are at increased risk of developing MTB and AMI. Clinicians should be aware of this risk and consider screening patients for latent MTB prior to initiating ruxolitinib. Patients on ruxolitinib may be predisposed to mycobacterial infections. This observational, retrospective, pharmacovigilance study used the United States Food and Drug Administration adverse events reporting system to compare the number of patients that developed typical and atypical mycobacterial infections to all drugs in the system. Using the reporting odds ratio (ROR), there is an increased risk of developing tuberculosis (ROR, 9.2; 95{\%} confidence interval, 7.5-11.4) and atypical mycobacterial infections (ROR, 8.3; 95{\%} confidence interval, 5.5-12.6) while on treatment with ruxolitinib.",
keywords = "Atypical mycobacterial infection, Mycobacterium tuberculosis, Myelofibrosis, Polycythemia vera, Tuberculosis",
author = "Kartik Anand and Burns, {Ethan A.} and {Ensor, Jr.}, {Joe Edward} and Lawrence Rice and Pingali, {Sai Ravi}",
year = "2020",
month = "1",
day = "1",
doi = "10.1016/j.clml.2019.08.008",
language = "English (US)",
volume = "20",
pages = "18--23",
journal = "Clinical Lymphoma, Myeloma and Leukemia",
issn = "2152-2650",
publisher = "Cancer Media Group",
number = "1",

}

RIS

TY - JOUR

T1 - Mycobacterial Infections With Ruxolitinib

T2 - Clinical Lymphoma, Myeloma and Leukemia

AU - Anand, Kartik

AU - Burns, Ethan A.

AU - Ensor, Jr., Joe Edward

AU - Rice, Lawrence

AU - Pingali, Sai Ravi

PY - 2020/1/1

Y1 - 2020/1/1

N2 - Background: Ruxolitinib is a selective Janus kinase inhibitor (JAKI) 1/2 approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). These patients may be at risk for developing opportunistic infections. We assessed the number of patients that developed typical (Mycobacterium tuberculosis [MTB]) and atypical mycobacterial infections (AMI) while on treatment with ruxolitinib by utilizing the United States Food and Drug Administration (FDA) adverse events reporting system (FAERS). Materials and Methods: This is a retrospective study utilizing FAERS, a pharmacovigilance database. We queried FAERS for cases of MTB and AMI secondary to ruxolitinib between January 1, 2011 and December 31, 2018. Disproportionality signal analysis was done by calculating the reporting odds ratio (ROR). ROR was considered significant when the lower limit of 95% confidence interval (CI) was > 1. Results: There were 91 reported cases of MTB associated with ruxolitinib compared with 4575 cases from all other drugs. The ROR was significant at 9.2 (95% CI, 7.5-11.4). There were 23 reports of AMI with ruxolitinib compared with 1287 reported with all other drugs. The ROR was significant at 8.3 (95% CI, 5.5-12.6). Twelve (13.2%) patients with MTB and 8 (34.8%) with AMI died. Conclusion: Patients on ruxolitinib are at increased risk of developing MTB and AMI. Clinicians should be aware of this risk and consider screening patients for latent MTB prior to initiating ruxolitinib. Patients on ruxolitinib may be predisposed to mycobacterial infections. This observational, retrospective, pharmacovigilance study used the United States Food and Drug Administration adverse events reporting system to compare the number of patients that developed typical and atypical mycobacterial infections to all drugs in the system. Using the reporting odds ratio (ROR), there is an increased risk of developing tuberculosis (ROR, 9.2; 95% confidence interval, 7.5-11.4) and atypical mycobacterial infections (ROR, 8.3; 95% confidence interval, 5.5-12.6) while on treatment with ruxolitinib.

AB - Background: Ruxolitinib is a selective Janus kinase inhibitor (JAKI) 1/2 approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). These patients may be at risk for developing opportunistic infections. We assessed the number of patients that developed typical (Mycobacterium tuberculosis [MTB]) and atypical mycobacterial infections (AMI) while on treatment with ruxolitinib by utilizing the United States Food and Drug Administration (FDA) adverse events reporting system (FAERS). Materials and Methods: This is a retrospective study utilizing FAERS, a pharmacovigilance database. We queried FAERS for cases of MTB and AMI secondary to ruxolitinib between January 1, 2011 and December 31, 2018. Disproportionality signal analysis was done by calculating the reporting odds ratio (ROR). ROR was considered significant when the lower limit of 95% confidence interval (CI) was > 1. Results: There were 91 reported cases of MTB associated with ruxolitinib compared with 4575 cases from all other drugs. The ROR was significant at 9.2 (95% CI, 7.5-11.4). There were 23 reports of AMI with ruxolitinib compared with 1287 reported with all other drugs. The ROR was significant at 8.3 (95% CI, 5.5-12.6). Twelve (13.2%) patients with MTB and 8 (34.8%) with AMI died. Conclusion: Patients on ruxolitinib are at increased risk of developing MTB and AMI. Clinicians should be aware of this risk and consider screening patients for latent MTB prior to initiating ruxolitinib. Patients on ruxolitinib may be predisposed to mycobacterial infections. This observational, retrospective, pharmacovigilance study used the United States Food and Drug Administration adverse events reporting system to compare the number of patients that developed typical and atypical mycobacterial infections to all drugs in the system. Using the reporting odds ratio (ROR), there is an increased risk of developing tuberculosis (ROR, 9.2; 95% confidence interval, 7.5-11.4) and atypical mycobacterial infections (ROR, 8.3; 95% confidence interval, 5.5-12.6) while on treatment with ruxolitinib.

KW - Atypical mycobacterial infection

KW - Mycobacterium tuberculosis

KW - Myelofibrosis

KW - Polycythemia vera

KW - Tuberculosis

UR - http://www.scopus.com/inward/record.url?scp=85075377497&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85075377497&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2019.08.008

DO - 10.1016/j.clml.2019.08.008

M3 - Article

VL - 20

SP - 18

EP - 23

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

SN - 2152-2650

IS - 1

ER -

ID: 60146103