| アブストラクト | Objective: This study aimed to investigate the potential association between biological disease-modifying antirheumatic drugs (bDMARDs) and pericarditis and uncover relevant clinical characteristics in ankylosing spondylitis (AS). Methods: Reports of pericarditis recorded in the FDA Adverse Event Reporting System (FAERS) (January 2004-December 2022) were identified through the preferred term "pericarditis." Demographic and clinical characteristics were described, and disproportionality signals were assessed through the reporting odds ratio (ROR) and information component (IC). A significant signal was detected if the lower bound of IC (IC(025)) was more than zero. Results: We found 1,874 reports of pericarditis with bDMARDs (11.3% of cases with fatal outcomes). Adalimumab (IC(025) 3.24), infliximab (IC(025) 4.90), golimumab (IC(025) 5.40), certolizumab (IC(025) 5.43), etanercept (IC(025) 3.24), secukinumab (IC(025) 3.97), and ustekinumab (IC(025) 7.61) exhibit significant disproportionality signals compared to other medications in the FAERS database. After excluding pre-existing diseases and co-treated drugs that may increase the susceptibility of pericarditis, the disproportionality signal associated with infliximab, certolizumab, etanercept, secukinumab, and ustekinumab remained strong. Pericarditis cases associated with all bDMARDs were predominantly recorded in women aged 25-65 years. Conclusion: More reports of pericarditis were detected with AS patients on bDMARDs than with other drugs in the overall database. Further studies are warranted to investigate the underlying mechanisms and identify patient-related susceptibility factors, thus supporting timely diagnosis and safe(r) prescribing of bDMARDs. |
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| 投稿者 | Xia, Shuang; Li, Yun-Fei; Raschi, Emanuel; Zhang, Bi-Kui; Noguchi, Yoshihiro; Sarangdhar, Mayur; Yan, Miao; Ma, Jin-An |
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| 組織名 | Department of Pharmacy, The Second Xiangya Hospital, Central South University,;Changsha, China.;International Research Center for Precision Medicine, Transformative Technology;and Software Services, Changsha, China.;Toxicology Counseling Center of Hunan Province, Changsha, China.;Department of Oncology, The Second Xiangya Hospital of Central South University,;Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater;Studiorum-University of Bologna, Bologna, Italy.;Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.;Division of Biomedical Informatics, Cincinnati Children's Hospital Medical;Center, Cincinnati, OH, United States.;Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati,;OH, United States.;Department of Pediatrics, University of Cincinnati College of Medicine,;Cincinnati, OH, United States. |
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