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Article History

Received: 21 March 2025

Accepted: 23 May 2025

First Online: 5 July 2025

Declarations

:

: Rohit Aggarwal has received research grants or contracts from Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Mallinckrodt, Pfizer, and Q32 Bio; and has acted as a consultant for Alexion, ANI Pharmaceuticals, Argenx, Artasome, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta Bio, Capella Bioscience, Corbus, CSL Behring, EMD Serono, Galapagos, Horizon Therapeutics, I-Cell, Immunovant, Janssen, Kezar, Kyverna, Lilly, Novartis, Nuvig Therapeutics, Octapharma, Pfizer, Roivant, Sanofi, Teva, Tourmaline Bio, and Verismo Therapeutics. Joachim Schessl has received support for the current manuscript and funding and consultancy fees from Octapharma; and honoraria for presentations from Pfizer. Zsuzsanna Bata-Csörgő has received payment or honoraria for lectures from Sanofi, Berlin-Chemie and AbbVie; support for attending meetings from Sanofi and Biotest AG; and unpaid board membership in the Hungarian Dermatology and Immunology and Allergy Societies. Mazen M. Dimachkie has received grants from Alexion/AstraZeneca, Alnylam Pharmaceuticals, Amicus, Argenx, Bristol Myers Squibb, Catalyst, CSL Behring, FDA/OOPD, GlaxoSmithKline, Genentech, Grifols, Mitsubishi Tanabe Pharma, MDA, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma/UCB Biopharma, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, and The Myositis Association; consultancy fees, payment, or honoraria for lectures, presentations, manuscript writing, or educational events, and participated on a Data Safety Monitoring Board or Advisory Board for Abata/Third Rock, Abcuro, Amicus, Argenx, Astellas, Cabaletta Bio, Catalyst, CNSA, Covance/Labcorp, CSL Behring, Dianthus, Horizon, EMD Serono/Merck, Fortrea, Ig Society, Inc., Ipsen, Janssen, Medlink, Nuvig Therapeutics, Octapharma, Priovant, Sanofi Genzyme, Shire Takeda, TACT/Treat NMD, UCB Biopharma, and ValenzaBio; and received royalty fees or licenses, consultancy fees, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Wolters Kluwer Health/UpToDate. Zoltan Griger has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AbbVie, Lilly, Novartis, Roche; received support for attending meetings and/or travel from Biotest, CSL Behring, Novartis, AbbVie, and Lilly; and participated on a Data Safety Monitoring Board or Advisory Board for Octapharma. Chester V. Oddis has received research support from Genentech and consulting fees from Pfizer. Elena Schiopu has received fees for consultancy and speaking bureaus from Johnson and Johnson and Novartis; and received research funds as institutional PI from SetPoint, Galapagos, Johnson and Johnson, BI, Lilly, Argenx, EMD Serrono, Priovant, Novartis, BMS, Zena Pharmaceuticals and Horizons/Amgen. Jiri Vencovský has received support for the current manuscript from the Czech Ministry of Health; grants or contracts from AbbVie; consulting fees from Argenx, Eli Lilly, and ReBait; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Werfen and Octapharma; and participated on a Data Safety Monitoring Board or Advisory Board for Horizon, Kezar, Galapagos, Boehringer, and Octapharma. Elisabeth Clodi is an employee of Octapharma Pharmazeutika Produktionsges.m.b.H. Todd Levine is a consultant for FFF Enterprises. Christina Charles-Schoeman has received grants or contracts from Pfizer, Bristol Myers Squibb, AbbVie, CSL Behring, Alexion, and Priovant; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie, Octapharma, Galapagos, Recludix, and Boehringer Ingelheim Pharmaceuticals. Sergey Moiseev has no conflicts of interest to declare.

: The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. ProDERM was approved by the relevant independent ethics committees or institutional review boards, as listed in the Ethics Committees section of the Supplementary Material. Each patient provided written, informed consent before being exposed to any study-related procedure, including screening tests for eligibility [, ]. Specific consent for publication was not provided as all data in this international study (from 36 European and North American centers) is fully anonymized.