Volume 10, Issue 3 (2024)
Pharm Biomed Res 2024, 10(3): 203-228 |
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Tanaka H, Maezawa M, Nakao S, Miyasaka K, Hirofuji S, Yamashita M, et al . Analysis of Adverse Events With Janus Kinase Inhibitors Reported to Spontaneous Reporting System. Pharm Biomed Res 2024; 10 (3) :203-228
URL: http://pbr.mazums.ac.ir/article-1-560-en.html
URL: http://pbr.mazums.ac.ir/article-1-560-en.html
Hideyuki Tanaka1 
, Mika Maezawa1 , Satoshi Nakao1 , Koumi Miyasaka1 , Sakiko Hirofuji1 , Moe Yamashita1 , Kensuke Matsui1 , Nanaka Ichihara1 , Yuka Nokura1 , Mari Iwata1 , Mayumi Kitamura2 , Megumi Horibe2 , Hirofumi Tamaki3 , Kazuhiro Iguchi3 , Mitsuhiro Nakamura *1
, Mika Maezawa1 , Satoshi Nakao1 , Koumi Miyasaka1 , Sakiko Hirofuji1 , Moe Yamashita1 , Kensuke Matsui1 , Nanaka Ichihara1 , Yuka Nokura1 , Mari Iwata1 , Mayumi Kitamura2 , Megumi Horibe2 , Hirofumi Tamaki3 , Kazuhiro Iguchi3 , Mitsuhiro Nakamura *1
1- Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
2- Department of Nursing, School of Health Science, Asahi University, Gifu, Japan.
3- Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.
2- Department of Nursing, School of Health Science, Asahi University, Gifu, Japan.
3- Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.
Abstract: (1345 Views)
Background: Janus kinase (JAK) inhibitors are recently launched treatments with a new mechanism of action, so their safety needs to be verified through long-term usage.
Objectives: This study aimed to determine the clinical characteristics of JAK inhibitor-related adverse events (AEs) in a real-world setting, using data from the Japanese adverse drug event report (JADER) database.
Methods: AEs are defined using the preferred terms from the dictionary of medical terms for regulatory agencies and include pneumonia, herpes zoster (HZ), hematopoietic erythropenia, hematopoietic leukopenia, hematopoietic thrombocytopenia, liver disorder, renal impairment, interstitial lung disease (ILD), cardiac failure, embolic and thrombotic events, gastrointestinal perforation, and hyperglycemia. Adjusted reported odds ratios (ROR) are used to assess disproportionality in the pharmacovigilance data, and time-to-onset analysis is performed using Weibull shape parameters.
Results: The JADER database contained 823662 reports published between April 2004 and March 2023. Pneumonia and HZ are associated with all JAK inhibitors except filgotinib. Adjusted RORs for pneumonia with peficitinib, tofacitinib, baricitinib, ruxolitinib, filgotinib, and upadacitinib are 4.4 (95% CI, 3.36%, 5.75%), 6.93 (95% CI, 6.18%, 7.77%), 6.51 (95% CI, 5.52%, 7.67%), 3.3 (95% CI, 2.76%, 3.95%), 4.39 (95% CI, 2.55%, 7.58%), and 6.11 (95% CI, 4.53%, 8.23%), respectively. Adjusted RORs for HZ with peficitinib, tofacitinib, baricitinib, ruxolitinib, and upadacitinib are 8.94 (95% CI, 5.69%, 14.05%), 31.82 (95% CI, 27.58%, 36.71%), 34.96 (95% CI, 28.92%, 42.26%), 5.24 (95% CI, 3.57%, 7.7%), and 33.19 (95% CI, 23.81%, 46.27%), respectively. The median time-to-onset of pneumonia and HZ with JAK inhibitor usage ranged from 2 to 6 months and 4 to 7 months, respectively.
Conclusion: We demonstrated the potential risks of JAK inhibitor use with real-world data. The present analysis shows that patients receiving peficitinib, tofacitinib, baricitinib, ruxolitinib, filgotinib, or upadacitinib should be closely monitored for AEs. The most common AEs associated with JAK inhibitors were pneumonia and HZ.
Objectives: This study aimed to determine the clinical characteristics of JAK inhibitor-related adverse events (AEs) in a real-world setting, using data from the Japanese adverse drug event report (JADER) database.
Methods: AEs are defined using the preferred terms from the dictionary of medical terms for regulatory agencies and include pneumonia, herpes zoster (HZ), hematopoietic erythropenia, hematopoietic leukopenia, hematopoietic thrombocytopenia, liver disorder, renal impairment, interstitial lung disease (ILD), cardiac failure, embolic and thrombotic events, gastrointestinal perforation, and hyperglycemia. Adjusted reported odds ratios (ROR) are used to assess disproportionality in the pharmacovigilance data, and time-to-onset analysis is performed using Weibull shape parameters.
Results: The JADER database contained 823662 reports published between April 2004 and March 2023. Pneumonia and HZ are associated with all JAK inhibitors except filgotinib. Adjusted RORs for pneumonia with peficitinib, tofacitinib, baricitinib, ruxolitinib, filgotinib, and upadacitinib are 4.4 (95% CI, 3.36%, 5.75%), 6.93 (95% CI, 6.18%, 7.77%), 6.51 (95% CI, 5.52%, 7.67%), 3.3 (95% CI, 2.76%, 3.95%), 4.39 (95% CI, 2.55%, 7.58%), and 6.11 (95% CI, 4.53%, 8.23%), respectively. Adjusted RORs for HZ with peficitinib, tofacitinib, baricitinib, ruxolitinib, and upadacitinib are 8.94 (95% CI, 5.69%, 14.05%), 31.82 (95% CI, 27.58%, 36.71%), 34.96 (95% CI, 28.92%, 42.26%), 5.24 (95% CI, 3.57%, 7.7%), and 33.19 (95% CI, 23.81%, 46.27%), respectively. The median time-to-onset of pneumonia and HZ with JAK inhibitor usage ranged from 2 to 6 months and 4 to 7 months, respectively.
Conclusion: We demonstrated the potential risks of JAK inhibitor use with real-world data. The present analysis shows that patients receiving peficitinib, tofacitinib, baricitinib, ruxolitinib, filgotinib, or upadacitinib should be closely monitored for AEs. The most common AEs associated with JAK inhibitors were pneumonia and HZ.
Type of Study: Original Research |
Subject:
Clinical Pharmacy
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