Apremilast for oral ulcers associated with active Behcet's syndrome over 68 weeks: long-term results from a phase 3 randomised clinical trial
Apremilast for oral ulcers associated with active Behcet's syndrome over 68 weeks: long-term results from a phase 3 randomised clinical trial
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DOI：
10.55563/clinexprheumatol/ra8ize
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发表时间：
2021-01-01
影响因子：
3.7
通讯作者：
Yazici, Y.
中科院分区：
文献类型：
--
作者：
Hatemi, G.;Mahr, A.;Yazici, Y.
Objective.本研究评估了阿普斯特治疗白塞氏综合征（BS）相关口腔溃疡长达64周的疗效和安全性。III期、双盲、安慰剂对照RELIEF研究将活动性BS成人患者随机分配至安慰剂或阿普斯特30 mg每日两次，持续12周，随后是扩展期，所有患者接受阿普斯特治疗至第64周和治疗后4周随访（治疗停止后）。主要终点是12周内口腔溃疡数量的曲线下面积（AUCWk 0 -12），反映了随时间推移的口腔溃疡数量，并解释了其复发-缓解过程。在整个研究过程中还评估了口腔溃疡数量、完全和部分缓解、疼痛和疾病活动度以及生活质量（QoL）。共有207例受试者接受了随机化，并接受了至少一剂研究药物; 178例进入扩展期，143例完成了第64周。与安慰剂相比，阿普斯特的AUCWk 0 -12显著降低（p
Objective. This study assessed the efficacy and safety of apremilast for the oral ulcers associated with Behcet's syndrome (BS) up to 64 weeks.Methods. The phase 3, double-blind, placebo-controlled RELIEF study randomised adult patients with active BS to placebo or apremilast 30 mg twice daily for 12 weeks, followed by an extension phase with all patients receiving apremilast through Week 64 and 4-week post-treatment follow-up (upon treatment discontinuation). The primary endpoint was area under the curve for the number of oral ulcers over 12 weeks (AUCWk0-12), reflecting the number of oral ulcers over time and accounting for their recurring-remitting course. Oral ulcer number, complete and partial responses, pain and disease activity and quality of life (QoL) were also assessed throughout the study.Results. A total of 207 participants were randomised and received at least one dose of study medication; 178 entered the extension phase and 143 completed Week 64. AUCWk0-12 was significantly lower with apremilast versus placebo (p