Department of Medical Education, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan,
Department of Dermatology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
Dermatology. 2022;238(6):1060-1072. doi: 10.1159/000524608. Epub 2022 Jun 13.
Dupilumab ameliorates the signs and symptoms of atopic dermatitis (AD) and improves the patient's quality of life. Multiple-dose regimens of dupilumab have been applied by clinicians, but the efficacy of some regimens remains unclear.
The aim of the study was to systematically evaluate the efficacy and safety of multiple dupilumab dose regimens in patients with moderate-to-severe AD in terms of comprehensive outcomes.
We searched electronic databases and subjected the selected studies to risk-of-bias assessment and network meta-analysis (NMA). Efficacy and safety outcomes were compared using a random-effects NMA to estimate pooled relative risk ratio (RR) of direct and indirect comparisons among multiple dupilumab dose regimens. The Eczema Area Severity Index, Investigator's Global Assessment, and pruritus numerical rating scale were analyzed to assess the efficacy, while adverse events (AEs) and serious adverse events to represent the safety.
Eight randomized controlled trials involving 3,679 patients were identified. Most patients received therapy for 16 weeks. Multiple dupilumab dose regimens, including 300 mg weekly (QW), 300 mg every 2 weeks (Q2W), 200 mg Q2W, 300 mg monthly (QM), 300 mg every 2 months (Q2M), and 100 mg QM were analyzed. All regimens, except 100 mg QM, had significantly better efficacy than placebo. 300 mg QW and 300 mg Q2W appeared to have similar efficacy. Notably, both 300 mg QW and 300 mg Q2W had no significantly better efficacy than 300 mg QM. As for 300 mg Q2M, significantly reduced efficacy was noted in only one efficacy outcome when compared to 300 mg QW and 300 mg Q2W. In terms of safety outcomes, AEs occurring with any of the regimens were comparable with the placebo. No significant inconsistency was noted within the network in all efficacy outcomes.
Our NMA indicated that the administration of the following dupilumab regimens was effective for patients with moderate-to-severe AD: 300 mg QW, 300 mg Q2W, 200 mg Q2W, 300 mg QM, and 300 mg Q2M. Our data can improve the understanding of the relative efficacy and safety of multiple dupilumab dose regimens, which will help in shared decision-making between clinicians and patients.
度普利尤单抗可改善特应性皮炎（AD）的体征和症状，并提高患者的生活质量。临床医生已经应用了多种剂量方案的度普利尤单抗，但一些方案的疗效仍不清楚。
本研究旨在系统评价多种度普利尤单抗剂量方案在中重度 AD 患者中的疗效和安全性，从综合结局方面进行评估。
我们检索了电子数据库，并对选定的研究进行了风险偏倚评估和网络荟萃分析（NMA）。使用随机效应 NMA 比较了多种度普利尤单抗剂量方案之间的直接和间接比较的疗效结局，以估计汇总相对风险比（RR）。使用湿疹面积严重程度指数、研究者全球评估和瘙痒数字评分量表评估疗效，同时使用不良事件（AE）和严重不良事件代表安全性。
共纳入了 8 项随机对照试验，涉及 3679 名患者。大多数患者接受了 16 周的治疗。分析了多种度普利尤单抗剂量方案，包括每周 300 mg（QW）、每 2 周 300 mg（Q2W）、200 mg Q2W、每月 300 mg（QM）、每 2 个月 300 mg（Q2M）和每月 100 mg QM。除了 100 mg QM 外，所有方案均显著优于安慰剂。300 mg QW 和 300 mg Q2W 似乎具有相似的疗效。值得注意的是，300 mg QW 和 300 mg Q2W 与 300 mg QM 相比，在任何一种疗效结局上均无显著更好的疗效。至于 300 mg Q2M，与 300 mg QW 和 300 mg Q2W 相比，仅在一项疗效结局中观察到疗效显著降低。在安全性结局方面，任何方案的 AE 发生率与安慰剂相当。在所有疗效结局中，网络内未观察到显著不一致性。
我们的 NMA 表明，对于中重度 AD 患者，以下度普利尤单抗方案是有效的：300 mg QW、300 mg Q2W、200 mg Q2W、300 mg QM 和 300 mg Q2M。我们的数据可以提高对多种度普利尤单抗剂量方案相对疗效和安全性的理解，有助于临床医生和患者之间进行共同决策。
