Kartik Anand1, Ethan A Burns2, Joe Ensor3, Lawrence Rice3, Sai Ravi Pingali4. 1. Houston Methodist Cancer Center/Weill Cornell Medicine, Houston, TX. Electronic address: kartikanand88@gmail.com. 2. Department of Internal Medicine, Institute of Academic Medicine, Houston Methodist Hospital, Houston, TX. 3. Houston Methodist Cancer Center/Weill Cornell Medicine, Houston, TX. 4. Houston Methodist Cancer Center/Weill Cornell Medicine, Houston, TX. Electronic address: spingali@houstonmethodist.org.
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.
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.
Authors: Vanessa Daza-Cajigal; Adriana S Albuquerque; Dan F Young; Michael J Ciancanelli; Dale Moulding; Ivan Angulo; Valentine Jeanne-Julien; Jérémie Rosain; Ekaterina Minskaia; Jean-Laurent Casanova; Stéphanie Boisson-Dupuis; Jacinta Bustamante; Richard E Randall; Timothy D McHugh; Adrian J Thrasher; Siobhan O Burns Journal: Front Immunol Date: 2022-09-09 Impact factor: 8.786
Authors: Kartik Anand; Geetanjali Sahu; Ethan Burns; Allyne Ensor; Joe Ensor; Sai Ravi Pingali; Vivek Subbiah; Swaminathan P Iyer Journal: ESMO Open Date: 2020-08