Sun, Wan
Fennimore, Blair
Beaulieu, Dawn B.
Arsenescu, Razvan
Stein, Adam C.
Chen, Jingjing
Lin, Tiffany
McKnight, Sonya
Kadali, Harisha
Rosario, Maria
Lirio, Richard A. http://orcid.org/0000-0001-8342-9942
Funding for this research was provided by:
Takeda Pharmaceuticals U.S.A.
Article History
Accepted: 8 January 2021
First Online: 5 February 2021
Declarations
:
: This work was supported by Takeda.
: Jingjing Chen, Sonya McKnight, Harisha Kadali, and Richard A. Lirio are Takeda employees and hold Takeda stock or stock options. Blair Fennimore has no conflicts of interest that are directly relevant to the content of this article. Dawn B. Beaulieu reports consulting fees from Takeda and AbbVie. Razvan Arsenescu reports consulting and speaker fees from Takeda. Adam C. Stein reports consulting and speaker fees from AbbVie and speaking fees from Pfizer. Tiffany Lin is contracted by Takeda via Certara. Wan Sun and Maria Rosario were Takeda employees at the time this research was conducted, and Maria Rosario reports granted patents and pending patent applications relating to the clinical pharmacology of vedolizumab.
: The study design and protocol were approved by the local ethics committee or institutional review board at each participating site, or by a central institutional review board, as applicable.
: All patients provided written informed consent to participate. The decision to treat with vedolizumab or to breastfeed was made independently from and prior to the patient consenting to participate in this study.
: Not applicable.
: The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants’ data supporting the results reported in this article, will be made available within 3 months from an initial request, to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
: Not applicable.
: WS, JC, TL, SM, MR, and RAL contributed to the study concept and design. BF, DBB, RA, ACS, and SM participated in the data acquisition. WS, BF, DBB, RA, ACS, JC, TL, HK, MR, and RAL provided the data analysis and interpretation. All authors had access to the data and participated in drafting and revising the manuscript. All authors approved the final draft for submission.