P105 Reporting of concomitant and rescue topical therapies in eczema randomized controlled trials evaluating a systemic treatment: a scoping review
Authors: Wei Chern Gavin Fong, Sophie Leducq, Hywel Williams, Lucy Bradshaw, Kim Thomas
Journal: British Journal of Dermatology (2024)

Abstract The landscape of atopic dermatitis (AD) treatment has witnessed an exponential increase in randomized controlled trials (RCTs) exploring systemic medications. These trials often incorporate topical therapies, such as topical corticosteroids and calcineurin inhibitors, either as permitted concomitant treatments (concomitant) or as rescue medications (rescue). Variable use of these topicals after randomization introduces potential bias as they may nullify or exaggerate treatment responses differentially. Factors such as treatment duration, application frequency and quantity further complicate the interpretation of trial results. Despite these complexities, there is a scarcity of literature addressing the systematic reporting of topical therapy details in AD clinical trials, particularly when evaluating systemic treatments. To address this gap, we reviewed current practices in reporting topical treatments in RCTs of AD systemic medication. Our primary objectives included determining the proportion of RCTs that clearly report the allowance or prohibition of concomitant and rescue topical treatments. Secondary outcomes involved examining the reporting of specific parameters for these topicals, such as type, potency, duration and application quantity. We used logistic regression models to explore the association between trial characteristics and clearly reporting the use of rescue therapy. We screened RCTs of AD systemic medication included in the living systematic review and network meta-analysis of AD systemic treatments by Drucker et al. (n = 83), spanning from inception to March 2023 (Drucker AM, Lam M, Elsawi R et al. Comparing binary efficacy outcomes for systemic immunomodulatory treatments for atopic dermatitis in a living systematic review and network meta-analysis. Br J Dermatol 2024; 190: 184–90). The majority adequately reported the allowance or prohibition of concomitant topical treatments (96%, 64 of 67), but this clarity was less prevalent regarding rescue topicals (73%, 49 of 67). All trials permitting concomitant therapies consistently reported the type, although details on potency (89%, 31 of 35), duration (54%, 19 of 35), application frequency (34%, 12 of 35) and quantity (6%, 2 of 35) were less frequently reported. Similarly, trials allowing rescue treatments often specified the type (91%, 31 of 34) but provided limited information on potency (53%, 18 of 34), duration (9%, 3 of 34), application frequency (6%, 2 of 34) and quantity (0%, 0 of 34). Notably, only 24% (8 of 34) clearly reported the criteria for using rescue topical treatments, with the phrase ‘at investigator’s discretion’ being used in most cases (62%, 21 of 34). In multivariate logistic regression models, the variable ‘publication year ≥ 2020’ was significantly associated with reporting the use of rescue topicals (adjusted odds ratio 9.55, 95% confidence interval 1.73–83, P &amp;lt; 0.001). Indeed, 31 of 33 trials published in 2020 or after clearly reported their use. In conclusion, while most AD clinical trials of systemic treatments report concomitant topical treatments, reporting practices for rescue topicals were less consistent and inadequate. The observed association with clearer reporting in more recent publications suggests a positive trend. Nonetheless, a standardized approach to reporting topical therapy in AD trials is needed to enhance transparency and interpretability.