Potential Adverse Events Reported With the Janus Kinase Inhibitors Approved for the Treatment of Rheumatoid Arthritis Using Spontaneous Reports and Online Patient Reviews

Song, Young-Gi; Song, Junu; Kim, Kyungim; Kwon, Jin-Won

doi:10.3389/fphar.2021.792877

Cited by 10 publications

(4 citation statements)

References 30 publications

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“…Moreover, many previous studies and papers have used these methods to detect adverse event signals in spontaneous reporting systems. 52 – 54 …”

Section: Discussionmentioning

confidence: 99%

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

Jiang,

Su,

et al. 2024

Therapeutic Advances in Drug Safety

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Background: Drug-induced interstitial lung disease (DILD) is an increasingly common cause of morbidity and mortality. However, due to the lack of specificity, DILD detection remains an unsolved public health challenge. Objectives: For the first time, we aimed to examine DILD reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to identify demographic characteristics and top drugs associated with DILD at a group level (including age, sex, drug class, and country stratification) and individual drug level. Design: A retrospective analysis of the FAERS database was examined by disproportionality analysis. Methods: We reviewed the FAERS database from 2004 to 2021, using search terms ‘interstitial lung disease’ and sorting cases by generic drug name. The reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network were calculated as the measure of strength of association. Results: There were 32,821 DILD reports in the FAERS. After excluding reports without age, sex, or country data according to the specific measurement, the median age of patients was 68 (interquartile range: 59), 54.77% were male, and 46.00% of reports came from Japan. The top drug classes related to DILD in the FAERS were antineoplastic, followed by cardiovascular and antirheumatic agents, in varying order in different sexes. Fam-trastuzumab deruxtecan-nxki, ramucirumab, and eribulin were the top three drugs with the highest strength of association. We also found some drugs without DILD in the labels, such as amiodarone, temsirolimus, and ursodiol. There are significant differences in DILD reports in various countries. For example, the United States and France reported more cardiovascular agents, whereas Canada reported more antirheumatic agents. Conclusion: We found the top drugs and drug classes that were associated with DILD in the FAERS, which provides a real-world window for different ages, sexes, and countries to formulate precise pharmacovigilance policies.

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“…Moreover, many previous studies and papers have used these methods to detect adverse event signals in spontaneous reporting systems. 52 – 54 …”

Section: Discussionmentioning

confidence: 99%

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

Jiang,

Su,

et al. 2024

Therapeutic Advances in Drug Safety

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“… 20 , 21 We verify the stability of the detection signal by the proportional reporting rate method. 22 , 23 The application of the proportional reporting ratio and 95% confidence intervals (CIs) from the two-by-two contingency table are shown in Table 1 . According to EMA guideline, to reduce the probability of a false-positive signal, a significant signal was defined as reported odds ratio (ROR) > 2 with at least 10 cases.…”

Section: Methodsmentioning

confidence: 99%

Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS

Chai

Zhan

Zhao

et al. 2022

Therapeutic Advances in Drug Safety

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Background: Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs). Methods: Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021 were selected for disproportionality analysis to assess the connection between antifungal triazoles, and AEs and important medical events (IMEs). Results: A total of 22,566 records associated with triazole antifungals were identified, with 9584 triazole antifungal–IME pairs. The following system organ classes (SOCs) appeared as significant signals: ‘Endocrine disorders’ [reported odds ratio (ROR) = 167.94], ‘Metabolism and nutrition disorders’ (ROR = 46.30), and ‘Skin and subcutaneous tissue disorders’ (ROR = 21.37). Strong signals were observed with respiratory failure, rash, hepatic function abnormal, and hypokalemia. Uncommon security signals included a change in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations. Conclusion: Various triazole antifungals cause AEs of different types and intensities of association. Our results are broadly consistent with prescribing information and previous studies; however, additional pharmacoepidemiological studies are required to verify AEs with modest incidence but high signal. Plain Language Summary A study on the adverse effects of triazole antifungals Introduction: The triazole antifungals we studied include fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole. Triazole antifungals are widely used as broad-spectrum antifungals; however, there are many undetected and unreported adverse events (AEs). Materials and Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA by different countries regarding post-marketing drugs. Through the FAERS database, we retrieved a total of 22,566 AE reports related to triazole antifungals. We not only counted information about patients’ gender, age, weight, reporting country, outcome indicators, and indications but also analyzed the system organ classes (SOCs) of AEs, and the number of reported drug-related AEs and the degree of relevance. Results: We found a total of 22,566 records related to triazole antifungal agents, of which 9584 reports made important medical events (IMEs) about triazole antifungal agents, which are serious AEs. The following SOCs appear as important signals: ‘endocrine disorders’, ‘metabolic and nutritional disorders’, and ‘skin and subcutaneous tissue disorders’. Triazole antifungals produce AEs, such as respiratory failure, rash, hepatic function abnormal, and hypokalemia. They also produce uncommon AEs, including changes in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations. Conclusion: By analyzing data from the FAERS database, we identified more AEs associated with these five triazole antifungals than were indicated in the instructions and our findings provide additional insight into triazole-related AEs to inform clinicians before and during treatment.

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“…JAK signalling has been directly and indirectly associated with the production of inflammatory cytokines, playing a significant role in inflammatory mechanisms 82 . In the studies included in this review, three JAK inhibitors were shown to reduce pain severity in patients with psoriatic and rheumatoid arthritis -tofacitinib 77,78,[83][84][85] , baricitinib 79,[86][87][88] , and upadacitinib 76,89 , throughout over 12 months of treatment 90 . Other disease-modifying drugs further include hydroxychloroquine, methotrexate, and sulfasalazine; however, these were not effective in reducing pain severity in patients with osteoarthritis 91 and chikungunya arthritis 92 .…”

Section: Pharmacological Treatments For Chronic Musculoskeletal and V...mentioning

confidence: 99%

Recent advances in the pharmacological treatment of chronic pain: a systematic review

Fonseca-Rodrigues,

Almeida,

Pinto-Ribeiro

2024

DOR

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Chronic pain is one of the most important public health concerns, greatly impacting the patients' quality of life and with high societal and economical costs. Despite advances in the understanding of pain mechanisms and the establishment of several strategies to decrease pain severity in patients, there continues to be a substantial proportion of patients who are refractory to the currently available treatments. Recently, novel pharmacological strategies have been developed for the treatment/ management of chronic pain, directed at symptoms and psychological complications of the illness. In this work, we performed a systematic review of the recent advances in pharmacological strategies for chronic pain. For that purpose, we searched a total of four databases (PubMed, Science Direct, Web of Science, and Scopus) for clinical trials testing drugs in patients with chronic pain, completed between the years 2017 and 2021 (1 st January 2017 up to 17 th November 2021). The different treatments were analysed and compared regarding their effectiveness, indications, and side effects. We included 166 studies, which provided information on 46 796 participants, mostly women (64%). This review pools together data on novel drug therapeutic strategies or improved applications of already known drugs, from opioids to monoclonal antibodies, providing researchers and health professionals with tools to ameliorate human chronic pain research and management.

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Potential Adverse Events Reported With the Janus Kinase Inhibitors Approved for the Treatment of Rheumatoid Arthritis Using Spontaneous Reports and Online Patient Reviews

Cited by 10 publications

References 30 publications

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS

Recent advances in the pharmacological treatment of chronic pain: a systematic review

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