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Article History

Accepted: 9 May 2025

First Online: 24 September 2025

Declarations

:

: This study was funded by Regeneron Pharmaceuticals Inc. and Sanofi.

: R.G. Langley received honoraria as a principal investigator, scientific advisor, or speaker for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers-Squibb, Dermavant, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, Sanofi-Genzyme, Sun Pharma, UCB Pharma, and Union. G. Gherardi, A. Rodríguez-Marco, and A.B. Rossi are employees of Sanofi and may hold stock and/or stock options in the company. A. Coleman, M. Ardeleanu, S. Levy, A. Bansal, Z. Chen, B. Shumel, and F.A. Khokhar are employees and shareholders of Regeneron Pharmaceuticals Inc.

: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing (1) once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA, etc.) or development of the product has been discontinued globally for all indications on or after April 2020 and there are no plans for future development (2) if there is legal authority to share the data and (3) there is not a reasonable likelihood of participant re-identification. Submit requests to .

: Ethical approval was obtained for individual studies included in this analysis. All trials were conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guideline, and applicable regulatory requirements. Independent data and safety monitoring committees conducted blinded monitoring of patient safety data. The local institutional review boards or ethics committees at each study center oversaw trial conduct and documentation.

: For each trial, all patients or their parents/guardians provided written informed consent before participating in the trial. Written informed consent was obtained from all patients and the patients’ parents/guardians prior to commencement of any study treatment.

: Not applicable.

: Not applicable.

: A.C., A.B.R., B.S., and F.A.K. contributed to concept and design of the analyses described in this manuscript. Z.C. conducted the statistical analyses of the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and were accountable for the accuracy and integrity of the manuscript.

: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing (1) once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA, etc.) or development of the product has been discontinued globally for all indications on or after April 2020 and there are no plans for future development (2) if there is legal authority to share the data and (3) there is not a reasonable likelihood of participant re-identification. Submit requests to .