Dataset Information

Effect of treatments on skin microbiota in patients with atopic dermatitis: a protocol for systematic review.

ABSTRACT:

Introduction

Atopic dermatitis (AD) is a chronic inflammatory skin disease and skin microbiota dysbiosis shows an important role in the pathogenesis of AD. Effects of treatment on skin microbiota for patients with AD have been evaluated in recent years; however, the results remained controversial across studies. This systematic review will summarise studies evaluating the effect of treatments on skin microbiota among patients with AD.

Methods and analysis

We will search PubMed, EMBASE, Web of Science, ClinicalTrials.gov and Chinese Clinical Trial Registry in November 2021; other data sources will also be considered, including searching specific authors and screening references cited in the enrolled articles. Interventional studies, which enrolled patients with AD receiving treatments and reported treatment-related skin microbiota changes, will be included. Our primary outcomes include skin microbiota diversity and treatment-related differential microbes; the secondary outcomes include microbiota functions and microbial interactions. Risk of bias assessment will be performed using Cochrane risk-of-bias tool for randomised trials, risk of bias in non-randomised studies of interventions and methodological index for non-randomised studies. Two researchers will independently perform study selection, data extraction and risk of bias assessment, with disagreements resolved by group discussions. Subgroup analyses will be performed according to different types of treatment for AD.

Ethics and dissemination

Ethics approval is not required for this systematic review. Findings will be disseminated via peer-reviewed publication or conference proceedings.

Prospero registration number

CRD42021246566.

SUBMITTER: Guo Y

PROVIDER: S-EPMC8744091 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNumerous therapies have recently emerged for treatment of patients with atopic dermatitis (AD), a common skin disease, and understanding their cost-effectiveness is of high importance for policy makers. This systematic literature review (SLR) aimed to provide an overview of full economic evaluations that assessed cost-effectiveness of emerging AD treatments.MethodsThe SLR was conducted in Medline, Embase, UK National Health Service Economic Evaluation Database and EconLit. Reports published by the National Institute for Health and Care Excellence, the Institute for Clinical and Economic Review and the Canadian Agency for Drugs and Technologies in Health were manually searched. Economic evaluations published from 2017 to September 2022 that compared emerging AD treatments with any comparator were included. Quality assessment was conducted by using the Consensus on Health Economic Criteria list.ResultsA total of 1333 references were screened after removing duplicates. Among those references, 15 that conducted a total of 24 comparisons were included. Most studies were from the USA, UK or Canada. Seven different emerging treatments were compared, mostly with usual care. In 15 comparisons (63%), the emerging treatment was cost-effective, and 11 out of 14 dupilumab comparisons (79%) reported that dupilumab was cost-effective. Upadacitinib was the only emerging therapy that was never classified as cost-effective. On average, 13 out of 19 quality criteria (68%) per reference were rated as fulfilled while manuscripts and health technology reports received generally higher quality assessment scores than published abstracts.DiscussionThis study revealed some discrepancies in the cost-effectiveness of emerging therapies for AD. A variety of designs and guidelines made comparison difficult. Therefore, we recommend that future economic evaluations use more similar modelling approaches to improve comparability of results.OthersThe protocol was published in PROSPERO (ID: CRD42022343993).

Project description:ImportanceMost clinical trials assessing systemic immunomodulatory treatments for patients with atopic dermatitis are placebo-controlled.ObjectiveTo compare the effectiveness and safety of systemic immunomodulatory treatments for patients with atopic dermatitis in a systematic review and network meta-analysis.Data sourcesThe Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Latin American and Caribbean Health Science Information database, Global Resource of Eczema Trials database, and clinical trial registries were searched from inception to October 28, 2019.Study selectionEnglish-language randomized clinical trials of 8 weeks or more of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis were included. Titles, abstracts, and articles were screened in duplicate. Of 10 324 citations, 39 trials were included.Data extraction and synthesisData were extracted in duplicate, and the review adhered to Preferred Reporting Items for Systematic Reviews and Meta-analyses for Network Meta-Analyses guidelines. Random-effects bayesian network meta-analyses were performed and certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria.Main outcomes and measuresPrespecified outcomes were change in signs of disease, symptoms, quality of life, itch, withdrawals, and serious adverse events.ResultsA total of 39 trials with 6360 patients examining 20 medications and placebo were included. Most trials were conducted for adults receiving up to 16 weeks of therapy. Dupilumab, 300 mg every 2 weeks, was associated with improvement in the Eczema Area and Severity Index score vs placebo (mean difference, 11.3-point reduction; 95% credible interval [CrI], 9.7-13.1 [high certainty]). Cyclosporine (standardized mean difference, -1.1; 95% CrI, -1.7 to -0.5 [low certainty]) and dupilumab (standardized mean difference, -0.9; 95% CrI, -1.0 to -0.8 [high certainty]) were similarly effective vs placebo in clearing clinical signs of atopic dermatitis and may be superior to methotrexate (standardized mean difference, -0.6; 95% CrI, -1.1 to 0.0 [low certainty]) and azathioprine (standardized mean difference, -0.4; 95% CrI, -0.8 to -0.1 [low certainty]). Several investigational medications for atopic dermatitis are promising, but data to date are limited to small early-phase trials. Safety analyses were limited by low event rates.Conclusions and relevanceDupilumab and cyclosporine may be more effective for up to 16 weeks of treatment than methotrexate and azathioprine for treating adult patients with atopic dermatitis. More studies directly comparing established and novel treatments beyond 16 weeks are needed and will be incorporated into future updates of this review.