| アブストラクト | OBJECTIVE: The pathophysiological mechanisms involved in systemic sclerosis (SSc), especially the triggering factor, are poorly understood. The literature supporting the role of drugs in the onset of SSc primarily relies on case reports, short series or previous studies of old drugs. We aimed to update the list of suspected drugs associated with SSc (DASSc). METHODS: Analyzing the World Health Organization (WHO) pharmacovigilance database (Vigibase(R)), we collected all individual case safety reports (ICSRs) of drugs putatively associated with SSc reported since 1967 using the Medical Dictionary for Regulatory Activities preferred terms "systemic sclerosis" and "scleroderma". For each drug, a disproportionality analysis was performed by calculating the information component (IC). An identified drug was considered significant if the IC025 was >0. RESULTS: A total of 2800 deduplicated ICSRs of DASSc were identified, accounting for 509 ICSRs and 38 suspected DASSc after exclusion of protopathic and indication biases. Anticancer drugs were the most represented drug class, accounting for 16/38 (42%) of DASSc and 317/509 (62.3%) of ICSRs, which occurred mostly in the first years after the introduction of the drugs. Among these, taxane-based agents, bleomycin, vinblastine, imatinib, dacarbazine, pembrolizumab and pemetrexed were associated with the highest disproportionate reporting. Hormone replacement therapy, romiplostim and eculizumab were associated with a significant signal. DASSc was considered a serious adverse drug reaction in 404 (92%, n = 441) cases with 41 (9%) cases resulting in death. CONCLUSION: Several new drugs with significant disproportionality signals were identified as potential drugs implicated the development of SSc, particularly anticancer drugs. |
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| ジャーナル名 | Autoimmunity reviews |
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| 投稿日 | 2022/7/29 |
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| 投稿者 | Dumont, Anael; Dolladille, Charles; de Boysson, Hubert; Alexandre, Joachim; Nguyen, Alexandre; Deshayes, Samuel; Aouba, Achille |
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| 組織名 | Department of Internal Medicine, Caen University Hospital, Avenue de la Cote de;Nacre, 14000 Caen, France; Normandie Univ, UNICAEN, UR4650 PSIR, CHU de Caen;Normandie, 14000 Caen, France. Electronic address: dumont-an@chu-caen.fr.;Department of Pharmacology, CHU de Caen Normandie, 14000 Caen, France; Caen;University-Normandy, UNICAEN, INSERM U1086 ANTICIPE, Avenue du General Harris,;CHU de Caen-Normandie, Caen F-14000, France.;Normandie, 14000 Caen, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35902047/ |
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