Atopiclair_Roundtable_Supplement_Saved_Version.qxd 11/12/08 10:59 AM Page C1 Supplement B to the November issue of MAS063DP (Atopiclair ®) for the Treatment of Atopic Dermatitis in Infants and Children: Proceedings of a Roundtable Discussion Atopiclair_Roundtable_Supplement_Saved_Version.qxd 11/12/08 10:59 AM Page C2 Participants A Message from the Moderator: Adelaide A. Hebert, MD Eric W. Baum, MD, MSc The science of atopic der- Director of Medical Education matitis has come a long way in the Alabama Dermatology Society last few years. While today, der- Gadsden, Alabama matologists are using the term Dr. James Del Rosso, DO, FAOCD barrier dysfunction, it was not Dermatology Residency Director something that specialists dis- Valley Hospital Medical Center Clinical Associate Professor cussed two or three years ago, (Dermatology) even though it was known that University of Nevada School of Medicine, Las Vegas, Nevada there was a barrier defect that Associate Professor (Dermatology) required ongoing management. A Touro University College of Osteopathic Medicine growing need for nonsteroidal Henderson, Nevada therapy for atopic dermatitis exists, especially for infants and chil- dren. Nonsteroidal barrier repair is currently being intensely re- searched. An important recent study involves a nonsteroidal, barrier repair cream by the name of Atopiclair® (Graceway Pharmaceuticals, LLC, Bristol, Tennessee). The following clinical review discusses a multi- center, randomized, placebo-controlled study evaluating the efficacy and safety of Atopiclair in infants and children with mild-to-moderate Gregory A. Dwyer, MD atopic dermatitis. The study demonstrated that Atopiclair cream is Little Rock Dermatology Clinic effective and safe as a monotherapy for the treatment of symptoms Little Rock, Arkansas of mild-to-moderate atopic dermatitis in infants and children. Mark Boguniewicz, MD, of the National Jewish Medical and Research Center in Denver, Colorado, was the lead investigator for this impor- tant pediatric study.1 Adelaide A. Hebert, MD, is Professor of Dermatology and Pediatrics at the University of Texas—Houston Medical School, in Joseph S. Eastern, MD Houston, Texas. Dr. Hebert is board certified in dermatology, pedi- Belleville Dermatology Center Belleville, New Jersey atric dermatology, and wound healing. Her medical training includes a fellowship in pediatric dermatology at Northwestern University. She joined the dermatology faculty of UT Houston in 1986. This supplement is based on a roundtable discussion that took place on June 28, 2008, at the Sandestin Beach Hilton Hotel in Mark D. Herron, MD Sandestin, Florida. Dr. Hebert moderated the discussion. Clinical Instructor Roundtable participants included Drs. Baum, Del Rosso, Dwyer, Department of Dermatology University of Alabama at Birmingham Eastern, and Herron. This supplement was supported by Graceway Birmingham, Alabama Pharmaceuticals and did not undergo peer review by The Journal of Clinical and Aesthetic Dermatology’s Editorial Advisory Board. Atopiclair_Roundtable_Supplement_Saved_Version.qxd 11/12/08 10:59 AM Page 3 MAS063DP (Atopiclair®) for the Treatment of Atopic Dermatitis in Infants and Children Proceedings of a Roundtable Discussion Introduction On June 28, 2008, a roundtable discussion was held to endpoints included IGA at other time points, patient’s/care- review the management of atopic dermatitis in pediatric giver’s assessment of pruritus, onset, duration of itch relief, patients. This roundtable took place during the Alabama Eczema Area and Severity Index (EASI), subject’s/caregiver’s Dermatological Society meeting in San Destin, Florida. Dr. assessment of global response, and need for rescue med- Adelaide Hebert, Professor of Dermatology and Pediatrics ication (such as a topical corticosteroid) in the event of an at the University of Texas Houston Medical School— atopic dermatitis flare. Atopiclair cream was statistically Houston, Texas, served as chair and moderator of the ses- more effective (P<0.0001) than vehicle cream for the pri- sion. A primary objective of the session was to discuss mary endpoint and all secondary endpoints and proved to recently published data on the use of a nonsteroidal topical be safe and well tolerated. The results of this pediatric study barrier repair cream that contains glycyrrhetinic acid 2%, were compared to those reported in a previous study com- hyaluronic acid, Vitis Vinifera extract (grapevine), pleted in adult subjects. telmesteine, and Butyrospermum parkii (shea butter), and The roundtable discussion was not limited to the is marketed under the trade name Atopiclair (Graceway results of the pediatric trial summarized above. Other Pharmaceuticals, LLC, Bristol, Tennessee). issues that were addressed included management of epi- A multicenter, randomized, vehicle-controlled study dermal barrier dysfunction, trigger factors for atopic der- recently published in the June 2008 issue of the Journal of matitis, superimposed bacterial infections, and associ- Pediatrics evaluated the use of Atopiclair as monotherapy ated behavioral and emotional sequelae of the disease. In for mild-to-moderate atopic dermatitis in infants and chil- addition to Dr. Hebert, who served as chair and modera- dren. This multicenter, randomized, placebo-controlled, 43- tor, other roundtable discussion participants included Eric day study included 142 subjects. Mark Boguniewicz, MD, of W. Baum, MD; Joseph S. Eastern, MD; Gregory A. Dwyer, the National Jewish Medical and Research Center in Denver, MD; and Mark D. Herron, MD. Colorado, served as lead investigator. Atopic dermatitis was We are hopeful that the information presented in this assessed to cover at least five-percent body surface area for roundtable proceedings will be helpful to you in clinical all patients at study entry, with evaluations occurring at practice. baseline and Days 3, 8, 15, 22, 29, and 43. The primary endpoint of this pediatric study was Investigator Global James Q. Del Rosso, DO, Editor-in-Chief, Clinical Dermatology, Assessment (IGA) of atopic dermatitis at Day 22. Secondary The Journal of Clinical and Aesthetic Dermatology [NOVEMBER 2008 • VOLUME 1 • NUMBER 4] SUPPLEMENT B TO THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY 3 Atopiclair_Roundtable_Supplement_Saved_Version.qxd 11/12/08 10:59 AM Page 4 Atopiclair is Effective Monotherapy for Mild to Moderate Atopic Dermatitis in Infants and Children: A Multicenter, Randomized, Vehicle-controlled Study Boguniewicz M, Zeichner JA, Eichenfield LF, et al. MAS063DP is effective monotherapy for mild to moderate atopic dermatitis in infants and children: a multicenter, randomized, vehicle-controlled study. J Pediatr. 2008;152(6):854-859. Study Highlights Objective. To examine the efficacy and safety of Atopiclair cream in the management of mild-to-moderate dermatitis in infants and children. Study design. One-hundred forty-two patients aged six months to 12 years were administered Atopiclair (n=72) or vehicle (n=70) cream three times per day to affected areas and sites prone to develop atopic dermatitis. The primary endpoint for efficacy was the Investigator’s Global Assessment at Day 22. Secondary endpoints included IGA at other time points, patient’s/caregiver’s assessment of pruritus, onset, duration of itch relief, Eczema Area and Severity Index (EASI), subject’s/caregiver’s assessment of global response, and need for rescue medication (such as a topical corticosteroid) in the event of an atopic dermatitis flare. Results. Atopiclair cream was statistically more effective (P<0.0001) than vehicle cream for the primary endpoint and all secondary endpoints. Treatment discontinuation as a result of an adverse event occurred in 9.9 percent of patients using Atopiclair cream and 16 percent of patients using vehicle cream. Conclusion. Atopiclair cream is effective and safe as monotherapy for the treatment of symptoms of mild-to-moderate atopic dermatitis in infants and children. 4 SUPPLEMENT B TO THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY [NOVEMBER 2008 • VOLUME 1 • NUMBER 4] Atopiclair_Roundtable_Supplement_Saved_Version.qxd 11/12/08 10:59 AM Page 5 MAS063DP (Atopiclair®) for the Treatment of Atopic Dermatitis in Infants and Children: Proceedings of a Roundtable Discussion Roundtable Discussion Atopiclair has antioxidant and antiprotease activity, which helps protect against breakdown of the epider- mis.4 Telmestine has antiprotease action and inhibits What was the objective of the recently elastase, collagenase, and matrix metalloproteinase, published Atopiclair pediatric trial? which are expressed at high levels in patients with atopic dermatitis.5 Atopic dermatitis has a complex etiology that encom- Finally, hyaluronic acid in the emollient helps to passes many genetic as well as environmental triggers hydrate the epidermis and restore barrier function. that compromise skin-barrier function. As a result of our The hyaluronic acid component is a naturally occur- understanding of the pathophysiology of atopic dermatitis ring glycosaminoglycan and is part of the ground sub- increasing in recent years, newer therapeutic options such stance of connective tissue, which immediately as Atopiclair have become available that may significantly smoothes skin upon application and, as a naturally improve quality of life for infants and children with atopic occurring substance, creates no immunogenic dermatitis. The objective of the pediatric trial was to response.6 The hyaluronic acid component may play a examine the efficacy and