Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 22 June 2023
First Online: 23 August 2023
Declarations
:
: This study was funded by Eli Lilly and Company, the manufacturer and licensee of mirikizumab. Eli Lilly and Company was involved in the study design, data collection, data analysis, and preparation of the manuscript, and paid the open access fees.
: Laiyi Chua and Xin Cindy Zhang are employees and minor shareholders of Eli Lilly and Company. Stuart Friedrich is a former employee of Eli Lilly and Company.
: The AMAC, LUCENT 1, and LUCENT 2 studies were approved by the applicable ethics review boards and performed in accordance with the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, and the International Council for Harmonisation Guideline for Good Clinical Practice.
: All patients provided written informed consent.
: Not applicable.
: Lilly 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.
: All authors participated in the design and interpretation of the study results, and in the drafting, critical revision, and approval of the final version of the manuscript. SF and XCZ contributed to the study conceptualization. LC curated the data and formal analysis. Validation and visualization of the data were performed by LC and SF.