Whether ibrutinib-related atrial fibrillation (IRAF) is a dose-dependent adverse drug reaction (ADR) and whether ibrutinib should be discontinued or dose-reduced in case of IRAF occurrence remains unknown. Using the World Health Organization individual case safety report pharmacovigilance database, VigiBase®, we aimed to determine the association between ibrutinib dosing regimens and IRAF reporting. Ibrutinib daily dose was extracted from IRAF cases from VigiBase® and was divided into 5 ibrutinib dosing regimen (140–280–420–560 and >560 mg/day). Disproportionality analysis was used to evaluate the association between IRAF reporting and ibrutinib daily dose, through logistic regression. Single term deletions produced the ibrutinib daily dose global p-value. Then, a multivariable adjusted reporting odds-ratio with its 95% confidence interval was calculated for each ibrutinib dosing regimen, against the lowest dosing regimen (140 mg/day) as reference. A total of 1162 IRAF cases were identified in VigiBase® (n = 62 for ibrutinib 140 mg/day, 114 for ibrutinib 280 mg/day, 811 for ibrutinib 420 mg/day, 164 for ibrutinib 560 mg/day and 11 for ibrutinib >560 mg/day). After adjustment on several variables of interest, IRAF reporting was not significantly associated with ibrutinib dosing regimen (p = 0.09). Our results from Vigibase® do not support IRAF as a dose-dependent ADR (ClinicalTrial registration number: NCT06224452).

依鲁替尼相关的心房颤动 (IRAF) 是否是一种剂量依赖性药物不良反应 (ADR)，以及在发生 IRAF 的情况下是否应停用依鲁替尼或减少剂量仍不清楚。使用世界卫生组织个案安全报告药物警戒数据库 VigiBase®，我们旨在确定依鲁替尼给药方案与 IRAF 报告之间的关联。依鲁替尼日剂量从 VigiBase® 的 IRAF 病例中提取，分为 5 个依鲁替尼给药方案（140–280–420–560 和 >560 mg/天）。不成比例分析用于通过逻辑回归评估 IRAF 报告与依鲁替尼每日剂量之间的关联。单项缺失产生了依鲁替尼日剂量全局p值。然后，针对每个依鲁替尼给药方案计算多变量调整报告比值比及其 95% 置信区间，并以最低给药方案（140 毫克/天）作为参考。 VigiBase® 共识别出 1162 例 IRAF 病例（依鲁替尼 140 毫克/天n = 62 例，依鲁替尼 280 毫克/天 114 例，依鲁替尼 420 毫克/天 811 例，依鲁替尼 560 毫克/天 164 例，依鲁替尼 11 例% 3E560 毫克/天）。对几个感兴趣的变量进行调整后，IRAF 报告与依鲁替尼给药方案没有显着相关性 ( p = 0.09)。我们的 Vigibase® 结果不支持将 IRAF 作为剂量依赖性 ADR（临床试验注册号：NCT06224452）。