Malhotra, Jyoti
Marchlewicz, Elizabeth H.
Zhang, Yan
Winer, Isabelle
Pack, Kenneth
Danes, Christopher
Le, Hoa H.
Hernandez, Luis
Funding for this research was provided by:
Takeda Pharmaceuticals U.S.A.
Article History
Received: 24 February 2026
Accepted: 5 June 2026
First Online: 9 July 2026
Declarations
:
: Elizabeth Marchlewicz, Isabelle Winer, and Kenneth Pack are employees of Veradigm, which received funding from Takeda Pharmaceuticals America, Inc. to conduct this study. Yan Zhang, Christopher Danes, Hoa Le, and Luis Hernandez and employees and own stock of Takeda. Jyoti Malhotra is paid consultant at Pfizer and Takeda, received grants or contracts from Astra Zeneca, and participated in an advisory board held by Takeda.
: The linked dataset only contained de-identified data as per the de-identification standard defined in Section §164.514(a) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The process by which the data were de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b) (1) of the HIPAA Privacy Rule. Because this study used only de-identified patient records, it was no longer subject to the HIPAA Privacy Rule and was therefore exempt from institutional review board approval and obtaining informed consent according to US law. The study was designed, implemented, and reported in accordance with the International Society for Pharmacoepidemiology Guidelines for Good Pharmacoepidemiology Practice, and was conducted in compliance with the ethical principles laid down in the Declaration of Helsinki and only used de-identified data.