Funding

This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifiers: NCT02277743, NCT02277769, NCT02755649, and NCT02260986. 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 provided by Sandra Dedrick, Ph.D., and Juliet H.A. Bell, Ph.D., of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals Inc.

Conflict of interest

Jonathan I. Silverberg is an investigator for AbbVie, Celgene, Lilly, GSK, Incyte, LEO Pharma, Realm Therapeutics, Regeneron Pharmaceuticals Inc. and Roche; a consultant for AbbVie, Anacor Pharmaceuticals, Lilly, Galderma, GSK, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, MedImmune, Menlo Therapeutics, Pfizer, Procter & Gamble, Realm Therapeutics, and Regeneron Pharmaceuticals Inc.; and a speaker for Regeneron Pharmaceuticals Inc. and Sanofi. Charles W. Lynde is an advisor, consultant, and speaker for AbbVie, Altius Pharmaceuticals, Amgen, Aralez Pharmaceuticals, Arcutis Biotherapeutics, Bausch Health, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher Pharmaceuticals, Dermavant, Lilly, Fresenius Kabi, Galderma, GSK, Innovaderm, Intega Skin Sciences, Janssen, Kyowa Kirin, La Roche-Posay, LEO Pharma, L’Oréal, Medexus Pharmaceuticals, Merck Group, Pfizer, Procter & Gamble, Pediapharm, Regeneron Pharmaceuticals Inc., Roche, Sanofi, Sentrex Health Solutions, Teva, Tribute Pharmaceuticals, UCB, Valeant, and Viatris. Katrina Abuabara has received personal fees from TARGET-DERM and is an investigator for Pfizer and L’Oréal. Cataldo Patruno is an investigator, speaker, consultant, and advisory board member for AbbVie, Amgen, Lilly, LEO Pharma, Novartis, Pfizer, Pierre Fabre, and Sanofi. Anna De Benedetto is a consultant for dMed and Incyte; has received grant support or clinical trial support from Dermira, Kiniksa Pharmaceuticals, Novartis, and Pfizer. Ryan B. Thomas, Faisal A. Khokhar, and Noah A. Levit are employees and shareholders of Regeneron Pharmaceuticals Inc. Haixin Zhang was an employee of Regeneron Pharmaceuticals Inc., and may have held stock/stock options in Regeneron Pharmaceuticals Inc. Ainara Rodríguez Marco and Gaëlle Bégo-Le-Bagousse are employees of Sanofi, and may hold stock and/or stock options in the company. Jignesh Vakil was an employee of Sanofi at the time of the study, may have held stock and/or stock options in Sanofi, and is currently an employee at Moderna.

Ethics approval

This study was conducted in accordance with 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.

Consent for publication

Not applicable as no personal patient-related data were used.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Noah A. Levit, Ainara Rodríguez Marco, and Haixin Zhang. The first draft of the manuscript was written by medical writer Sandra Dedrick, Ph.D., of Excerpta Medica, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Availability of data and material

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this article. Individual anonymized participant data will be considered for sharing once the indication is approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to https://vivli.org.

Code availability

Not applicable.