固定剂量克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%凝胶治疗中重度痤疮:4 项临床试验比较

L. Kircik, Z. Draelos, Michael Gold, Neil Sadick, Neal Bhatia
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引用次数: 0

摘要

介绍:建议大多数痤疮患者采用针对痤疮多种发病过程的联合疗法。抗生素、维甲酸和抗菌剂三管齐下,与单一疗法或双重组合产品相比,也可提高疗效。克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%(BPO)聚合网状凝胶(CAB)是美国 FDA 批准用于治疗痤疮的首款固定剂量三合一外用药。本分析的目的是在四项临床研究中比较每日一次的 CAB 与其三种成分二元凝胶、品牌阿达帕林 0.3%/BPO 2.5% 凝胶和载体的治疗成功率和效果大小。研究方法两项2期(NCT03170388、NCT04892706)和两项3期(NCT04214652、NCT04214639)双盲、随机、为期12周的研究招募了中重度痤疮患者。在所有研究中,第12周的治疗成功率(定义为评价者的总体严重程度评分和透明/几乎透明的皮肤比基线降低≥2级)是共同主要终点。其他共同主要终点(炎症性和非炎症性病变比基线减少)未在此显示。此外,还对治疗突发不良事件(TEAEs)和皮肤安全性/耐受性进行了评估。我们还对治疗所需人数(NNT)进行了事后分析,NNT 是指需要接受干预治疗的患者人数,与采用药物治疗的患者人数相比,NNT 更能衡量治疗效果,并能间接比较不同研究的数据。结果:在所有研究中,约有一半接受CAB治疗的参与者在第12周时取得了治疗成功(范围:49.6%-52.5%),而接受药物治疗的参与者只有不到四分之一取得了治疗成功(范围:8.1%-24.9%;P<0.01,所有研究),接受成分二联疗法或品牌阿达帕林0.3%/BPO 2.5%治疗的参与者只有不到三分之一取得了治疗成功(范围:27.8%-32.9%;P≤0.001,所有研究)。所有活性疗法的治疗成功率均明显高于药物疗法(P<0.01,全部)。CAB的NNT值(3-5)低于(优于)成分二联疗法(5-6)或品牌阿达帕林0.3%/BPO 2.5%(7),进一步表明疗效更佳。CAB的TEAE大多为轻度至中度。与阿达帕林/BPO二联凝胶相比,CAB凝胶的TEAE和停药率相似或更低。在所有时间点,CAB凝胶的平均皮肤安全性/耐受性评分均小于1分(轻度)。结论:CAB凝胶治疗中度至重度痤疮的疗效明显优于双组分凝胶和品牌阿达帕林0.3%/BPO 2.5%凝胶,约半数参与者在使用CAB 12周后皮肤变得清透/几乎清透。由于痤疮的发病机理,三重组合疗法可能比两种成分的组合产品更容易取得临床成功。资金来源:Ortho DermatologicsOrtho Dermatologics。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials
Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P<0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P<0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were <1 (mild) at all timepoints. Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. Funding: Ortho Dermatologics.
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