Study concept and design: Bachert, Mannent, Naclerio, Mullol, Ferguson, Gevaert, Hellings, Wang, Evans, Pirozzi, Graham, Swanson, Hamilton, Radin, Gandhi, Yancopoulos.
Acquisition, analysis, or interpretation of data: Bachert, Mannent, Naclerio, Mullol, Ferguson, Gevaert, Jiao, Wang, Evans, Pirozzi, Graham, Swanson, Hamilton, Radin, Stahl, Yancopoulos, Sutherland.
Drafting of the manuscript:Bachert, Mannent, Gevaert, Wang, Evans, Hamilton, Sutherland.
Critical revision of the manuscript for important intellectual content: Bachert, Mannent, Naclerio, Mullol, Ferguson, Gevaert, Hellings, Jiao, Evans, Pirozzi, Graham, Swanson, Hamilton, Radin, Gandhi, Stahl, Yancopoulos, Sutherland.
Statistical analysis: Jiao, Wang.
Obtained funding: Pirozzi, Gandhi.
Administrative, technical, or material support: Ferguson, Evans, Swanson, Hamilton, Radin, Sutherland.
Study supervision: Bachert, Mannent, Gevaert, Hellings, Evans, Pirozzi, Graham, Stahl, Yancopoulos, Sutherland.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bachert reported serving on advisory boards for and receiving personal fees from Sanofi and Novartis. Drs Mannent, Jiao, Wang, Pirozzi, Swanson, and Sutherland reported being employees and shareholders of Sanofi. Dr Naclerio reported receiving grant support from Meda Pharmaceuticals Inc, Merck, Nasaleze, Teva Pharmaceutical Industries Ltd, and Kalypsys Inc; and personal fees from Meda AB, Merck, GlaxoSmithKline, Teva Pharmaceutical Industries Ltd, and Sanofi. Dr Mullol reported receiving grant support from the Uriach Group, Meda Pharma, Faes Farma, Merck Sharp Dohme, and GlaxoSmithKline; and personal fees from Sanofi, the Uriach Group, Meda Pharma, ALK-Abelló A/S, Faes Farma, Hartington Pharmaceutical SL, Johnson & Johnson, the Menarini Group, Merck Sharp Dohme, GlaxoSmithKline, Crucell, Novartis, Pierre Fabre, and UCB. Dr Ferguson reported receiving consulting fees and travel reimbursement from Sanofi; and support for the conduct of studies from Meda Pharmaceuticals Inc, Teva Pharmaceutical Industries Ltd, Sanofi, and Knopp Biosciences. Dr Gevaert reported receiving grant support from Sanofi. Dr Hellings reported receiving grant support from Meda Pharma, GlaxoSmithKline, Merck, and ALK-Abelló. Drs Evans, Graham, Hamilton, Radin, Gandhi, Stahl, and Yancopoulos reported being employees and shareholders of Regeneron Pharmaceuticals Inc.
Funding/Support: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc.
Role of the Funder/Sponsor: Sanofi and Regeneron Pharmaceuticals Inc, in collaboration with the academic clinical investigators, provided input on the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the interpretation of the data and the preparation, review, and submission of the manuscript. The final decision on manuscript submission was made by the authors; the sponsors did not have the right to veto or require submission or publication.
Additional Contributions: We thank the patients for their participation, the members of the independent data and safety monitoring committee (James P. Kemp, MD [committee chair], Pharmaceutical Safety Services LLC, San Diego, California; Charles Anello, ScD, Applied Statistical Concepts LLC, West Palm Beach, Florida; Adelaide A. Hebert, MD, Department of Dermatology, University of Texas Medical School, Houston; Michael Kaliner, MD, Department of Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC; Shirley Murphy, MD, Pediatric Associates PA, Albuquerque, New Mexico; Marie A. Richard, MD, Department of Dermatology, Service de Dermatologie, Hôpital Ste Marguerite, Assistance Publique des Hôpital de Marseille and Research Unit LIMP EA 3291, Université de la Méditerranée, Marseille, France; and Lanny J. Rosenwasser, MD, Children’s Mercy Hospital, University of Missouri School of Medicine, Kansas City), and all the study investigators (a complete list appears in Supplement 2). Both the independent data and safety monitoring committee and the study investigators were compensated for their participation in the trial. We also thank Nikki Moreland, BSc, and Marinella Calle, PhD (both with Excerpta Medica), for copyediting assistance with language and format, medical writing support in accordance with authors’ guidance, redrawing of the figures, and collating the authors’ comments, which was funded by Sanofi and Regeneron Pharmaceuticals Inc. We thank the following persons for their contributions to data collection, analysis, statistical analysis, and review of the manuscript: Steven Weinstein, MD, PhD, Rebecca Gall, MD, and Linda Williams, RPh (all 3 with Regeneron) and Hongjie Zhu, PhD, Annette Grabher, MD, Patricia Rohane, MD, Ariel Teper, MD, Blandine Nembo, PhD, Sebastien Paoli, MSc, Suzana Todorovic, MSc, Nian Tian, MSc, Florence Benderitter, PhD, Pauline Wijnand, PharmD, Anna Bergos, MD, Brian Bock, DO, Katia Handelberg, MD, Donghui Zhang, PhD, Jeffrey Cortez, MSc, Barbara Zhang, MD, and Karen Mittleman, PhD (all 17 with Sanofi). Employees of Excerpta Medica, Sanofi, and Regeneron were not compensated for their contributions outside their regular salaries.