Oh Jiwon, Walker Bryan, Giovannoni Gavin, Jack Dominic, Dangond Fernando, Nolting Axel, Aldridge Julie, Lebson Lori A, Leist Thomas P
Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Duke University School of Medicine, Durham, NC, USA.
Mult Scler J Exp Transl Clin. 2021 Jul 13;7(3):20552173211024298. doi: 10.1177/20552173211024298. eCollection 2021 Jul-Sep.
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.
To identify TEAEs that begin early in the course of treatment in patients enrolled in CLARITY and ORACLE-MS studies.
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.
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%).
Cladribine tablets were well tolerated during the first 12 weeks as evidenced by a low incidence of TEAEs leading to treatment discontinuation.
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。
确定参加CLARITY和ORACLE-MS研究的患者在治疗过程早期出现的TEAE。
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。
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%）。
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。
