Leducq Sophie, Fong Wei Chern Gavin, Williams Hywel C, Bradshaw Lucy, Thomas Kim S
Centre of Evidence Based Dermatology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
Department of Dermatology, University Hospital of Tours, Tours, France.
Br J Dermatol. 2025 Apr 28;192(5):818-825. doi: 10.1093/bjd/ljaf031.
Randomized controlled trials (RCTs) evaluating new systemic treatments for atopic dermatitis (AD) have increased dramatically over the last decade. These trials often incorporate topical therapies either as permitted concomitant or rescue treatments. Differential use of these topicals postrandomization introduces potential bias as they may nullify or exaggerate treatment responses.
To determine the proportion of RCTs that clearly report the allowance or prohibition of concomitant and rescue topical treatments; and to examine the reporting of specific key parameters for these topicals.
We included RCTs of systemic AD medication included in a recent living systematic review. Inclusion criteria were published RCTs evaluating systemic immunomodulatory treatments in AD. Only anti-inflammatory topical therapies were included treatments in this review; emollients were not considered.
We screened 83 AD trials and included 67 RCTs published between 1991 and 2023. The majority adequately reported the allowance or prohibition of concomitant topical treatments (n = 64/67; 96%), but this clarity was less prevalent with regard to rescue topicals (n = 49/67; 73%). All trials that permitted concomitant treatments consistently reported the type, although details on potency (n = 31/35; 89%), duration (n = 19/35; 54%), application frequency (n = 12/35; 34%) and quantity (n = 2/35; 6%) were less frequently reported. Similarly, trials that allowed rescue treatments often specified the type (n = 31/34; 91%) but provided limited information on potency (n = 18/34; 53%), duration (n = 3/34; 9%), application frequency (n = 2/34; 6%) and quantity (n = 0/34; 0%). Notably, only 24% (n = 8/34) clearly reported the criteria for using rescue topical treatments, with the phrase 'at investigator's discretion' used in most cases (n = 21/34; 62%). In the multivariable logistic regression analysis including impact factor, the journal's policy on adhering to CONSORT guidelines, publication year, funding, number of patients randomized and blinding status, only publication year (≥ 2020) was associated with having better reporting for rescue topical treatments (adjusted odds ratio 9.55, 95% confidence interval 1.76-39.80).
While most clinical trials of systemic treatments in AD report concomitant topical treatments, reporting practices for rescue topicals are less consistent and inadequate. A standardized approach to reporting topical treatment in AD trials is needed to enhance transparency and interpretability.
在过去十年中，评估特应性皮炎（AD）新的全身治疗方法的随机对照试验（RCT）数量急剧增加。这些试验通常将局部治疗作为允许的辅助治疗或挽救治疗纳入。随机分组后这些局部治疗的不同使用方式会引入潜在偏倚，因为它们可能会抵消或夸大治疗反应。
确定明确报告允许或禁止使用辅助和挽救局部治疗的随机对照试验的比例；并检查这些局部治疗的特定关键参数的报告情况。
我们纳入了最近一项动态系统评价中包含的AD全身用药的随机对照试验。纳入标准为已发表的评估AD全身免疫调节治疗的随机对照试验。本评价仅将抗炎局部治疗纳入治疗；润肤剂未被考虑。
我们筛选了83项AD试验，纳入了1991年至2023年发表的67项随机对照试验。大多数试验充分报告了辅助局部治疗的允许或禁止情况（n = 64/67；96%），但在挽救局部治疗方面这种清晰度较低（n = 49/67；73%）。所有允许辅助治疗的试验均一致报告了类型，尽管关于效力（n = 31/35；89%）、持续时间（n = 19/35；54%）、应用频率（n = 12/35；34%）和用量（n = 2/35；6%）的详细信息报告较少。同样，允许挽救治疗的试验通常指定了类型（n = 31/34；91%），但关于效力（n = 18/34；53%）、持续时间（n = 3/34；9%）、应用频率（n = 2/34；6%）和用量（n = 0/34；0%）的信息有限。值得注意的是，只有24%（n = 8/34）明确报告了使用挽救局部治疗的标准，大多数情况下使用的表述是“由研究者自行决定”（n = 21/34；62%）。在包括影响因子、期刊遵循CONSORT指南的政策、发表年份、资金、随机分组的患者数量和盲法状态的多变量逻辑回归分析中，只有发表年份（≥2020）与更好地报告挽救局部治疗相关（调整后的优势比为9.55，95%置信区间为1.76 - 39.80）。
虽然大多数AD全身治疗的临床试验报告了辅助局部治疗，但挽救局部治疗的报告做法不太一致且不够充分。需要一种标准化的方法来报告AD试验中的局部治疗，以提高透明度和可解释性。
