Exploring changes in placebo treatment arms in hidradenitis suppurativa randomized clinical trials: A systematic review - 07/11/19

Doi : 10.1016/j.jaad.2019.05.065

Asma Amir Ali, MD, MBT ^a, Elizabeth K. Seng, PhD ^b,^c, Afsaneh Alavi, MD, MSc ^d, Michelle A. Lowes, MBBS, PhD ^e,^⁎
^a Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
^b Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, New York
^c Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, New York
^d Division of Dermatology, Department of Medicine, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada
^e The Rockefeller University, New York, New York

^∗Correspondence to: Michelle A. Lowes, MBBS, PhD, The Rockefeller University, 1230 York Ave, NY, 10065.The Rockefeller University1230 York AveNY10065

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Abstract

Background

Hidradenitis suppurativa (HS) is characterized by recurrent, painful nodules in flexural areas.

Objective

The objective of this study was to explore the placebo response in HS randomized clinical trials and to compare it briefly with the placebo response in psoriasis and atopic dermatitis.

Methods

A Cochrane Review on interventions in HS was used as a starting point, and a systematic review was then undertaken by using the PubMed database, yielding 7 HS randomized clinical trials for inclusion in this study.

Results

This review demonstrates that there is a robust placebo response in HS that is most marked in physical signs but also marked in pain responses.

Limitations

Multiple outcome measures utilized in these studies and reporting bias limited this review.

Conclusion

This large placebo response has implications for clinical trial design. This knowledge can also help deliver improved clinical care by forming the basis of nonpharmacologic treatments and help optimize current medication use to maximize the placebo effect.

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Key words : atopic dermatitis, clinical outcomes, clinical trial design, Hawthorne effect, hidradenitis suppurativa, pain, placebo response, psoriasis

Abbreviations used : AD, DLQI, HiSCR, HS, IL, NRS, RCT, VAS

Plan

Methods

Results

Hidradenitis suppurativa

Psoriasis

Atopic dermatitis

Discussion

RCT design implications

Clinical implications

Conclusions

	Alavi and Lowes contributed equally to this manuscript and are co-senior authors.
	Funding sources: None.
	Disclosure: Dr Seng has received research funding from the National Institute of Neurological Disorders and Stroke (grant 1K23 NS096107-01) and the International Headache Academy and has consulted for GlaxoSmithKline and Eli Lilly. Dr Alavi has been an investigator for AbbVie, Aristea, Asana, BMS, Eli Lilly and Company, Genentech, Glenmark, Incyte, InflaRx, Janssen, Kyowa, LEO, Novartis, Pfizer, Regeneron, and UCB; in addition, she has consulted for AbbVie, Galderma, Janssen, LEO, Novartis, Sanofi, and Valeant and has received an unrestricted educational grant from AbbVie. Dr Lowes has consulted for AbbVie, Incyte, and Xbiotech, Janssen, BSN, and Almirall. Dr Amir Ali has no conflicts to disclose.
	Earlier versions of this review were presented at the Canadian Society of Investigative Dermatology in Montreal, Canada, on June 21, 2018 and the Annual Symposium on Hidradenitis Suppurativa Advances in Toronto, Canada, on October 12-14, 2018.
	Reprints not available from the authors.