在两项针对多发性硬化症的3期试验中，氯法拉滨片治疗过程早期出现的治疗中突发不良事件。
Treatment-emergent adverse events occurring early in the treatment course of cladribine tablets in two phase 3 trials in multiple sclerosis.
作者信息
Oh Jiwon, Walker Bryan, Giovannoni Gavin, Jack Dominic, Dangond Fernando, Nolting Axel, Aldridge Julie, Lebson Lori A, Leist Thomas P
机构信息
Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Duke University School of Medicine, Durham, NC, USA.
出版信息
Mult Scler J Exp Transl Clin. 2021 Jul 13;7(3):20552173211024298. doi: 10.1177/20552173211024298. eCollection 2021 Jul-Sep.
BACKGROUND
Treatment-emergent adverse events (TEAEs) that occur close to treatment initiation may negatively affect overall tolerability and adherence. It is important to develop a clear understanding of potential early TEAEs after initiating treatment with cladribine tablets.
OBJECTIVE
To identify TEAEs that begin early in the course of treatment in patients enrolled in CLARITY and ORACLE-MS studies.
METHODS
This analysis of CLARITY and ORACLE-MS safety populations assessed the incidence of TEAEs, serious TEAEs, drug-related TEAEs, and TEAEs leading to discontinuation in patients receiving cladribine tablets or placebo within 2, 6, and 12 weeks after treatment initiation.
RESULTS
By Week 12, 61.3% of patients treated with cladribine tablets 3.5 mg/kg and 55.2% treated with placebo experienced a TEAE. More patients receiving cladribine tablets versus placebo experienced a drug-related TEAE by Week 12 (34.7% vs. 23.2%). The most common TEAEs reported with cladribine tablets were: headache (7.2%), lymphopenia (6.8%), and nausea (6.0%). Patients receiving cladribine tablets and placebo reported similar proportions of serious TEAEs (2.2% vs. 1.7%) and TEAEs leading to treatment discontinuation (1.6% vs. 1.4%).
CONCLUSION
Cladribine tablets were well tolerated during the first 12 weeks as evidenced by a low incidence of TEAEs leading to treatment discontinuation.
背景
在治疗开始时出现的治疗中出现的不良事件（TEAE）可能会对总体耐受性和依从性产生负面影响。在开始使用克拉屈滨片治疗后，清楚了解潜在的早期TEAE非常重要。
目的
确定参加CLARITY和ORACLE-MS研究的患者在治疗过程早期出现的TEAE。
方法
对CLARITY和ORACLE-MS安全人群的这项分析评估了在治疗开始后2周、6周和12周内接受克拉屈滨片或安慰剂治疗的患者中TEAE、严重TEAE、药物相关TEAE以及导致停药的TEAE的发生率。
结果
到第12周时，接受3.5mg/kg克拉屈滨片治疗的患者中有61.3%，接受安慰剂治疗的患者中有55.2%出现了TEAE。到第12周时，接受克拉屈滨片治疗的患者比接受安慰剂治疗的患者出现药物相关TEAE的更多（34.7%对23.2%）。克拉屈滨片报告的最常见TEAE为：头痛（7.2%）、淋巴细胞减少（6.8%）和恶心（6.0%）。接受克拉屈滨片和安慰剂治疗的患者报告的严重TEAE比例相似（2.2%对1.7%），导致治疗停药的TEAE比例也相似（1.6%对1.4%）。
结论
克拉屈滨片在前12周耐受性良好，导致治疗停药的TEAE发生率较低证明了这一点。
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