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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le vendredi 8 novembre 2019
Doi : 10.1016/j.jaad.2019.05.102
accepted : 30 May 2019
Placebo responses in randomized controlled trials for systemic therapy in atopic dermatitis: A systematic review and meta-analysis
 

Harrison H. Lee, BS a, Kevin R. Patel, MD a, Supriya Rastogi, MD a, Vivek Singam, MD a, Paras P. Vakharia, MD, PharmD a, Rishi Chopra, MD, MS a, Jonathan I. Silverberg, MD, PhD, MPH a, b, c, d,
a Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois 
b Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois 
c Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois 
d Northwestern Medicine Multidisciplinary Eczema Center, Chicago, Illinois 

Correspondence to: Jonathan I. Silverberg, MD, PhD, MPH, 676 N St. Clair St, Ste 1600, Chicago, IL 60611.676 N St. Clair StSte 1600ChicagoIL60611
Abstract
Background

Atopic dermatitis (AD) has a variable disease course and intermittent triggers, and responses to topical therapy vary, potentially affecting the magnitude of the placebo response in AD trials.

Objective

To determine the predictors of increased placebo response in randomized controlled trials of AD.

Methods

We performed a systematic review and meta-analysis of randomized controlled trials for systemic therapy in AD published during 2007-2018. We searched the Cochrane Library, Medline, Embase, Global Resource for EczemA Trials (GREAT), Literature of the Latin American and Caribbean Health Sciences (LILACS), and Scopus. Two authors performed study selection and data extraction. Multivariable mixed models were constructed for Cohen D of Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), numeric rating scale (NRS)–itch and visual analog scale (VAS)–itch, and Dermatology Life Quality Index (DLQI).

Results

Overall, 64 trials were included. Use of concomitant topical therapy prescriptions, study duration ≥3 months, and fewer treatment arms were associated with an increased placebo response for EASI, NRS- and VAS-itch, and DLQI. For EASI, the placebo response was increased in studies with a higher proportion of male patients, mild-moderate mean baseline EASI scores, and no blinding. For NRS-itch, and VRS-itch, higher placebo responses were associated with higher proportions of male patients and moderate-severe mean itch scores at baseline.

Conclusion

Placebo responses can be reduced in clinical trials of systemic therapy in AD by incorporating double- and triple-blinding, balancing the sex distribution of patients, disallowing concomitant use of prescription topical therapy, and having shorter study durations.

The full text of this article is available in PDF format.

Key words : atopic dermatitis, eczema, meta-analysis, placebo responses, randomized controlled trial, systematic review, systemic therapy

Abbreviations used : AD, CI, DLQI, EASI, NRS, RCT, SCORAD, SD, TCS, VAS



 Funding sources: Supported by the Dermatology Foundation.
 Conflicts of interest: None disclosed.
 Reprints not available from the authors.



© 2019  American Academy of Dermatology, Inc.@@#104156@@
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