Abstract：
OBJECTIVE: The study is aimed to evaluate the impact of safety events in the Eurofever registry for Autoinflammatory diseases.
METHODS: This was a retrospective and longitudinal observational multicentre study. Data were retrieved from the international registry Eurofever, starting patients\' enrolment since 2009. All moderate, severe, or very severe AEs reported by treating physician in Eurofever were analyzed regardless of a possible suspected causal relationship to any therapies and according to the latest release of the Medical Dictionary for Regulatory Activities.
RESULTS: Complete information on safety were available in 2464 patients enrolled in the registry. In 1499 of them retrospective data encompassing the period from disease onset to enrolment were available, whereas 965 consecutive patients entered in the longitudinal part of the study. A total of 479 AEs have been reported in 275 patients. Eighty-two AEs were reported as serious and 99 were drug-related according to the physicians. Infections or infestations (94; 19.6%), gastrointestinal disorders (66; 13.8%), nervous system disorders (41; 8.6%) and systemic disorders or administration site reactions (35; 7.3%) were the most frequent reported events. The highest absolute number of drug-related AEs were related to biologic DMARDs (40/99 reports, 40,4%) and colchicine (31/99 reports, 31.3%).
CONCLUSIONS: Present study shows the importance of a longitudinal and homogeneous registration of the AEs in rare conditions, with a particular focus on the safety profile of the treatments used in these conditions.
METHODS: This was a retrospective and longitudinal observational multicentre study. Data were retrieved from the international registry Eurofever, starting patients\' enrolment since 2009. All moderate, severe, or very severe AEs reported by treating physician in Eurofever were analyzed regardless of a possible suspected causal relationship to any therapies and according to the latest release of the Medical Dictionary for Regulatory Activities.
RESULTS: Complete information on safety were available in 2464 patients enrolled in the registry. In 1499 of them retrospective data encompassing the period from disease onset to enrolment were available, whereas 965 consecutive patients entered in the longitudinal part of the study. A total of 479 AEs have been reported in 275 patients. Eighty-two AEs were reported as serious and 99 were drug-related according to the physicians. Infections or infestations (94; 19.6%), gastrointestinal disorders (66; 13.8%), nervous system disorders (41; 8.6%) and systemic disorders or administration site reactions (35; 7.3%) were the most frequent reported events. The highest absolute number of drug-related AEs were related to biologic DMARDs (40/99 reports, 40,4%) and colchicine (31/99 reports, 31.3%).
CONCLUSIONS: Present study shows the importance of a longitudinal and homogeneous registration of the AEs in rare conditions, with a particular focus on the safety profile of the treatments used in these conditions.
摘要：
目的：本研究旨在评估欧罗热注册中安全性事件对自身炎症性疾病的影响。
方法：这是一项回顾性和纵向观察的多中心研究。数据来自国际注册中心欧热，自2009年开始患者登记。所有中等,严重,根据最新发布的《监管活动医学词典》，分析了治疗医生在欧热中报告的或非常严重的AE，而不考虑与任何疗法可能存在的可疑因果关系。
结果：在注册登记的2464名患者中获得了关于安全性的完整信息。在1499年，包括从疾病发作到登记期间的回顾性数据是可用的，而965名连续患者进入研究的纵向部分。在275例患者中总共报告了479例不良事件。据医生称，有82个AE被报告为严重的，99个与药物相关。感染或感染（94;19.6％），胃肠道疾病（66;13.8%），神经系统疾病(41;8.6%)和全身性疾病或给药部位反应(35;7.3%)是最常见的报告事件.药物相关AE的绝对数量最高的是与生物DMARDs相关(40/99报告，40,4%)和秋水仙碱(31/99报告，31.3%）。
结论：本研究表明，在罕见条件下，对AEs进行纵向和均匀配准的重要性，特别关注在这些情况下使用的治疗方法的安全性。
方法：这是一项回顾性和纵向观察的多中心研究。数据来自国际注册中心欧热，自2009年开始患者登记。所有中等,严重,根据最新发布的《监管活动医学词典》，分析了治疗医生在欧热中报告的或非常严重的AE，而不考虑与任何疗法可能存在的可疑因果关系。
结果：在注册登记的2464名患者中获得了关于安全性的完整信息。在1499年，包括从疾病发作到登记期间的回顾性数据是可用的，而965名连续患者进入研究的纵向部分。在275例患者中总共报告了479例不良事件。据医生称，有82个AE被报告为严重的，99个与药物相关。感染或感染（94;19.6％），胃肠道疾病（66;13.8%），神经系统疾病(41;8.6%)和全身性疾病或给药部位反应(35;7.3%)是最常见的报告事件.药物相关AE的绝对数量最高的是与生物DMARDs相关(40/99报告，40,4%)和秋水仙碱(31/99报告，31.3%）。
结论：本研究表明，在罕见条件下，对AEs进行纵向和均匀配准的重要性，特别关注在这些情况下使用的治疗方法的安全性。
