Drop B R H, Zemel D, Wokke B H A, van Oosten B W, Dik S, Martins Jarnalo C O, Westerweel P E, de Beukelaar J W K
Department of Neurology, Albert Schweitzer hospital, post office box 444, 3300AK, Dordrecht, Netherlands.
Department of Neurology, Erasmus Medical Center, post office box 2040, 3000CA, Rotterdam, Netherlands.
Mult Scler Relat Disord. 2021 Jan;47:102614. doi: 10.1016/j.msard.2020.102614. Epub 2020 Nov 16.
Alemtuzumab is effective in relapsing remitting multiple sclerosis (RRMS). Serious adverse events have led to a renewed safety reassessment by the European Medicines Agency (EMA), leading to an approval under strict conditions. We report a RRMS patient experiencing diffuse alveolar hemorrhage (DAH) on day 4 of her first alemtuzumab cycle. In addition, we present an overview of the cases of alemtuzumab-induced DAH that were included in EMA's review procedure, additional well documented cases reported to the EMA and those cases reported in the literature. Combining these cases revealed striking similarities. Importantly, DAH was an early complication. All RRMS patients with known outcome showed complete recovery.
阿仑单抗对复发缓解型多发性硬化症(RRMS)有效。严重不良事件促使欧洲药品管理局(EMA)重新进行安全性评估,最终在严格条件下批准了该药物。我们报告了1例RRMS患者在首次使用阿仑单抗治疗周期的第4天出现弥漫性肺泡出血(DAH)。此外,我们还概述了EMA审查程序中纳入的阿仑单抗诱发DAH的病例、向EMA报告的其他有充分文献记载的病例以及文献中报道的病例。综合这些病例发现了显著的相似之处。重要的是,DAH是一种早期并发症。所有已知转归的RRMS患者均完全康复。