Stein Gold, Linda
Thaçi, Diamant
Thyssen, Jacob P.
Gooderham, Melinda
Laquer, Vivian
Moore, Angela
Natalie, Chitra R.
Zhao, Fangyi
Meskimen, Eric
Elmaraghy, Hany
Montmayeur, Sonia
Gallo, Gaia
Jimenez, Gemma
de Bruin-Weller, Marjolein
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 8 May 2023
First Online: 17 May 2023
Declarations
:
: These studies were funded by Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company. Almirall, S.A., has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside of Europe.
: Linda Stein Gold has been an investigator, speaker, and/or advisory board member for: AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Aslan, Bausch Health, Boehringer Ingelheim, BMS, Celgene, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharmaceuticals, and UCB. Diamant Thaçi has been a consultant, investigator, speaker, and participant in scientific advisory boards for AbbVie, Almirall, Amgen, Bristol Myers Squibb, BMS, Janssen-Cilag, Galderma, Galapagos, LEO Pharma, Eli Lilly and Company, New-Bridge, Novartis, Pfizer, Regeneron, Samsung, Sanofi, Sun-Pharma, and UCB. Jacob P Thyssen has been a consultant for and/or has received grant/research/honorarium support from: Regeneron, Sanofi-Genzyme, LEO Pharma, AbbVie, Eli Lilly and Company, and Pfizer. Melinda Gooderham has been a speaker, investigator, or advisory board member for: AbbVie, Amgen, Akros, AnaptysBio, Arcutis, Arena, Aslan, Bausch Health, Boehringer Ingelheim, BMS, Celgene, Coherus, Dermira, Dermavant, Eli Lilly and Company, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharmaceuticals, Tarsus, UCB, and Ventyx. Vivian Laquer conducts research for Abbvie, Acelyrin, Acrotech, Biofrontera, Amgen, Argenx, Arcutis, Aslan, Bristol Meyers Squibb, Cara, Dermavant, Eli Lilly, Galderma, Horizon Therapeutics, Incyte, Janssen, Leo, Novartis, Padagis, Pfizer, Q32, Rapt, Sun, UCB, and Ventyx. Angela Moore has received study funds or honoraria from Abbvie, Aclaris, Acrotech, Almirall, Arcutis, Bayer, Bristol Myer Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, Galderma, Incyte, Janssen, Pfizer, Regeneron, and UCB. Chitra R. Natalie, Fangyi Zhao, Eric Meskimen, Hany Elmaraghy, Sonia Montmayeur, and Gaia Gallo are employees and stockholders of Eli Lilly and Company. Gemma Jimenez is an employee of Almirall. M. De Bruin-Weller has been a consultant, advisory board member, and/or speaker for AbbVie, Almirall, Amgen, Aslan, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme.
: Studies were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and approved by individual institutional review boards at each participating study center. Studies are registered on ClinicalTrials.gov (NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154).
: All patients provided written informed consent.
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and European Union, and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.
: Not applicable.
: Natalie, Zhao, Meskimen, Elmaraghy, Montmayeur, and Gallo have contributed to study conception, design, analysis, and data interpretation. Zhao has contributed to study analysis and interpretation. de Bruin-Weller and Thyssen contributed to data interpretation. Jimenez contributed to data analysis and interpretation. Gooderham and Laquer contributed to the acquisition of data. Moore and Stein Gold contributed to the acquisition and interpretation of data. Thaçi contributed to the design, acquisition, and interpretation of data. All authors contributed to the drafting or critical revision of the manuscript and give final approval of the manuscript.