Winning Poster: A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects with Recalcitrant Contact or Atopic Dermatitis

August 2011 | Volume 10 | Issue 8 | Features | 928 | Copyright © August 2011

Eva Volf MD

Abstract
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INTRODUCTION

This edition of Resident Spotlight features Dr. Eva Volf's winning poster, “A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects with Recalcitrant Contact or Atopic Dermatitis ” from the: Orlando Dermatology Aesthetic & Clinical (ODAC) conference Second Annual Advanced Resident Training & Education (ARTE) poster competition.

ABSTRACT

Atopic dermatitis (AD) and allergic contact dermatitis (ACD) are chronic inflammatory diseases characterized by pruritus. Current systemic treatments are associated with numerous end-organ toxicities. Apremilast is a novel phosphodiesterase 4 inhibitor that has demonstrated efficacy in phase 2 trials in patients with psoriasis or psoriatic arthritis. Here, we report the clinical efficacy and safety of apremilast in AD and ACD. The primary objective was to evaluate efficacy and safety of apremilast in subjects with recalcitrant moderate to severe AD or ACD.
The primary endpoint of improvement in IGA by two or more points was met by 20 percent of subjects. Ten percent of subjects achieved EASI-75 and 20 percent reached EASI-50. Subjects with diagnosis of ACD responded better to apremilast than subjects with AD, 42 percent mean reduction in EASI versus 20 percent mean increase in EASI, respectively. All subjects tolerated apremilast well with no serious adverse events or withdrawal due to side effects. Common adverse events associated with apremilast included headache, nausea, and soft stool.
Apremilast was well tolerated in all subjects. Apremilast was minimally effective in AD and ACD and results were inferior to previous trials of apremilast in psoriasis.
“A clinical trial the way it should be done. Well referenced.”
Alan R. Shalita, MD
ODAC Judge, Poster Session
“Dr. Volf and colleagues' poster on Apremilast was well designed and presented. Although treatment of psoriasis with Apremilast is encouraging, their study demonstrated that the response in atopic dermatitis and contact dermatitis is suboptimal.”
Mark Bechtel, M.D.
ODAC Judge, Poster Session
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Dr. Eva M. Volf is currently a medical intern at the University of Pittsburgh Medical Center- Shadyside in Pittsburgh. She earned her medical degree with research honors from Tufts University School of Medicine in May 2011. She has conducted research under the direction of Dr. Alice B. Gottlieb in psoriasis and atopic dermatitis. Dr. Volf will begin her Dermatology residency at Tufts Medical Center in Boston in July 2012.