Open access was funded by Sanofi and Regeneron Pharmaceuticals, Inc. This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. (ClinicalTrials.gov identifier: NCT01949311). The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. Medical writing and editorial assistance was provided by Carolyn Ellenberger, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
Conflict of interest
Lisa A. Beck: AbbVie, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, Inc.—investigator and consultant; Allakos, Arena Pharma, Astra Zeneca, LEO Pharma, Eli Lilly, Novan, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Vimalan—consultant; Medtronics, Pfizer—stock owner. Diamant Thaçi: AbbVie, Almirall, Amgen, Asana Biosciences, Beiersdorf, Boehringer Ingelheim, Celgene, Dermira, DS Biopharma, Eli Lilly, Galapagos, Galderma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Merck Sharp & Dohme, MorphoSys, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi, Sun Pharma, UCB—consultant, advisory board member, and/or investigator. Mette Deleuran: AbbVie, Almirall, Eli Lilly, Galapagos, LEO Pharma, Meda Pharma, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme—received research support and/or honoraria for lecturing, and consulting/advisory board agreements. Andrew Blauvelt: AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly, FLX Bio, Forte, Galderma, Janssen, LEO Pharma, Novartis, Ortho Derm, Pfizer, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi Genzyme, Sun Pharma, UCB—scientific adviser and clinical study investigator; AbbVie—paid speaker. Robert Bissonnette: AbbVie, Aquinox Pharmaceuticals, Arcutis Antiobix, Asana Biosciences, Astellas, Boehringer Ingelheim, Brickell Biotech, Dermavant, Dermira, Dignity Sciences, Eli Lilly, Galderma, Glenmark, GlaxoSmithKline-Stiefel, Hoffman-La Roche, Kiniksa, Incyte, LEO Pharma, NeoKera, Pfizer, Ralexar Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Vitae—consultant and/or has received grants/research support; Innovaderm Research—shareholder. Marjolein de Bruin-Weller: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme—Principal Investigator, advisory board member, consultant; AbbVie—Principal Investigator, advisory board member; Pfizer, Eli Lilly, UCB—advisory board member. Michihiro Hide: Kaken Pharmaceutical, Kyorin Pharmaceutical, Kyowa Hakko Kirin, Maruho, MDS, Mitsubishi Tanabe Pharma, Sanofi KK, Taiho Pharma, Teikoku Seiyaku, Torii Pharmaceutical, Uriach—honoraria for lectures. Lawrence Sher: Aimmune, Optinose, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme—advisory board member; Regeneron Pharmaceuticals, Inc., Sanofi Genzyme—speaker fees; Aimmune, Amgen, Astra Zeneca, Circassia, DBV, Galderma, GlaxoSmithKline, Lupin, Merck, Mylan, Novartis, Novo Nordisk, Optinose, Pearl, Pfizer, Pulmagen, Roxane, Sanofi, Spirometrix, Teva, Vectura, Watson—clinical trials funding. Iftikhar Hussain: CSL Behring, Genentech, Optinose, Pfizer—advisory board member; AbbVie, AnaptysBio, Asana Biosciences, Astra Zeneca, CSL Behring, Genentech, GlaxoSmithKline, Gossamer Bio, HAL Allergy, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Merck, Novartis, Optinose, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Shire, Vanda—Principal Investigator. Zhen Chen, Faisal A. Khokhar, Bethany Beazley, Marcella Ruddy, Neil M.H. Graham, Marius Ardeleanu, Brad Shumel: Regeneron Pharmaceuticals, Inc.—employees and shareholders. Naimish Patel: Sanofi—employee, may hold stock and/or stock options in the company.
This study was conducted in accordance with the ethical standards of the responsible committees and the Declaration of Helsinki, and with the International Conference on Harmonisation guidelines for Good Clinical Practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by Institutional Review Boards/Ethics Committees at all centers.
Consent to participate
Written informed consent was obtained from all patients or their proxies.