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. 2018 Aug 29;8(8):e023061.
doi: 10.1136/bmjopen-2018-023061.

Systemic immunomodulatory treatments for atopic dermatitis: protocol for a systematic review with network meta-analysis

Aaron Mark Drucker  1   2 , Alexandra Ellis  3 , Zarif Jabbar-Lopez  4 , Zenas Z N Yiu  5 , Bernd W M Arents  6 , Tim Burton  7 , Phyllis I Spuls  8 , Denise Küster  9 , Jochen Schmitt  9 , Carsten Flohr  4
Affiliations

Systemic immunomodulatory treatments for atopic dermatitis: protocol for a systematic review with network meta-analysis

Aaron Mark Drucker et al. BMJ Open. .

Abstract

Introduction: There are numerous new systemic treatments for atopic dermatitis in various stages of development and most are being compared with placebo rather than active comparators. In order to understand the relative efficacy and safety of existing and new treatments for atopic dermatitis, robust mixed comparisons (ie, direct and indirect) would be beneficial. To address this gap, this protocol describes methods for a systematic review and network meta-analysis of systemic treatments for atopic dermatitis.

Methods and analysis: We will update the search of a previous systematic review, including searches of the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Latin American and Caribbean Health Science Information database and the Global Resource of EczemA Trials database in addition to clinical trial protocol registries. Title, abstract and full paper screening as well as data extraction will be conducted in duplicate by independent researchers. Primary outcomes include efficacy with regards to clinician-reported signs and patient-reported symptoms and safety with regards to withdrawal from treatment due to adverse events and the occurrence of serious adverse events. Secondary outcomes will include change in quality of life and itch severity. Where possible and appropriate, network meta-analysis will be performed for each outcome using a random-effects model within a Bayesian framework. If appropriate, the review will be transitioned to a living review with continuous updating of the analysis.

Ethics and dissemination: Dissemination in a peer-reviewed scientific journal is planned.

Prospero registration number: CRD42018088112; Pre-results.

Keywords: adult dermatology; dermatology; eczema; paediatric dermatology.

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Conflict of interest statement

Competing interests: AMD: departmental research funding from Sanofi and Regeneron and consultancy for Sanofi, RTI Health Solutions and Eczema Society of Canada as well as Astellas Canada, Prime Inc, Spire Learning and the Eczema Society of Canada. PIS: principal investigator (PI) Methotrexate versus Azathioprine for severe Atopic Dermatitis (MAcAD) trial, PI of the Dutch national systemic therapy atopic eczema registry (TREAT NL) for adults and children. PS has served as a consultant to AbbVie, Anacor, Leo Pharma, Novartis and Sanofi, has received independent research grants (>4 years ago) from Leo Pharma and Schering-Plough and has been involved in performing clinical trials with pharmaceutical industries that manufacture drugs used for the treatment of atopic dermatitis. JS: department research funding from Sanofi, Pfizer, ALK, Novartis and MSD. PI of the German national AE registry (TREAT Germany). CF: chief investigator (CI) of the TREatment of severe Atopic eczema in children Trial (TREAT), a UK National Institute of Health Research-funded multicentre study comparing methotrexate and ciclosporin (www.treat-trial.org.uk). CI of the UK national systemic therapy atopic eczema registry (A*STAR) for adults and children. Consultancy for Sanofi/Regeneron. All other team members have no conflict of interest to declare.

References

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