Document is current

Article History

Accepted: 30 July 2025

First Online: 28 August 2025

Declarations

:

: This study was funded by Novartis Pharma AG, Basel, Switzerland.

: Kulli Kingo has received fees for serving as an investigator in studies sponsored by AbbVie, Celgene, Galderma, Merck, Mitsubishi Tanabe Pharma, Novartis, Regeneron Pharmaceuticals, and Sandoz. Stefan Beissert has been on the advisory board of AbbVie Deutschland GmbH & Co. KG, Actelion Pharmaceuticals Deutschland GmbH, Amgen GmbH, Celgene GmbH, Galderma Laboratorium GmbH, Janssen-Cilag GmbH, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, MSD SHARP & DOHME GmbH, Menlo Therapeutics, Sanofi-Aventis Deutschland GmbH, Pfizer Pharma GmbH, and UCB Pharma GmbH and received speaker honorarium from Novartis Pharma GmbH, AbbVie Deutschland GmbH & Co. KG, MSD SHARP & DOHME GMBH, Pfizer Pharma GmbH, Janssen-Cilag GmbH, Galderma Laboratorium GmbH, Celgene GmbH, La Roche-Posay Laboratoire Pharmaceutique, Actelion Pharmaceuticals Deutschland GmbH, GlaxoSmithKline GmbH & Co. KG, Bristol Myers Squibb GmbH & Co. KGaA, Sanofi-Aventis Deutschland GmbH, Almirall Hermal GmbH, and Sandoz/Hexal AG. Svetlana Lazareva and Jirina Bartonova declare no conflicts of interest. Asunción Vicente Villa has been an investigator in studies, advisor, speaker, and/or consultant for AbbVie, Almirall, Amgen, Amryt, Boehringer Ingelheim, Bristol Myers Squibb, Ferrer, Galderma, Jansen, LEO Pharma, Lilly, Novartis, Pierre Fabre, Pfizer, and Sanofi-Genzyme. Rosalia Ballona has received fees for serving as an investigator in this study sponsored by Novartis. Nina Magnolo has been an advisor, speaker, and/or consultant for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, La Roche-Posay, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, Dr. Wolff, Sanofi, and UCB Pharma. Amita Bansal, Ruvie Martin, Heng Fan, Charles O’Doherty, and Philemon Papanastasiou are employees and shareholders of Novartis. Shoba Ravichandran was a full-time employee at the time the research was conducted and is a current stockholder of Novartis.

: The datasets generated and/or analyzed during the current study are not publicly available. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. These requests are reviewed and approved on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The data may be requested from the corresponding author of the manuscript.

: The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and in compliance with all national, federal, local, or regional requirements. The institutional review board/ethics committee of each participating center approved the study protocol.

: A parent or legal guardian provided written informed consent, and the patient provided written assent, at screening before any assessment was performed. If patients reached age of consent (as per local law) during the study, they needed to also sign the corresponding study informed consent(s).

: Written informed consent was obtained from each patient or legal representative of the patient for anonymized patient information to be published.

: All authors were involved in the drafting and critical review of the manuscript and approved the final version for submission. K.K., S.B., S.L., A.V.V., J.B., R.B., and N.M. contributed to the design of the study and were involved in the acquisition of clinical data and participated as principal investigators in the clinical study from which data are reported in the manuscript. P.P., A.B., R.M., H.F., C.O.D., and S.R. were involved in the conception, design, and clinical conduct of the trial. R.M. and H.F. were involved in the analysis of the data in the manuscript. All authors were involved in the interpretation of data in the manuscript. All authors agreed to be accountable for all aspects of the work and attest to the accuracy and integrity of the work.