Hoffman, Veena http://orcid.org/0000-0003-4932-0892
Hallas, Jesper http://orcid.org/0000-0002-8097-8708
Linder, Marie http://orcid.org/0000-0003-2619-2189
Margulis, Andrea V. http://orcid.org/0000-0001-7388-6082
Suehs, Brandon T. http://orcid.org/0000-0003-4708-7484
Arana, Alejandro http://orcid.org/0000-0002-1593-3124
Phiri, Kelesitse http://orcid.org/0000-0002-6847-0231
Enger, Cheryl http://orcid.org/0000-0002-1007-851X
Horter, Libby http://orcid.org/0000-0003-2503-1690
Odsbu, Ingvild http://orcid.org/0000-0002-5337-8619
Olesen, Morten http://orcid.org/0000-0002-0937-4952
Perez-Gutthann, Susana http://orcid.org/0000-0001-5798-3691
Xu, Yihua
Kristiansen, Nina Sahlertz http://orcid.org/0000-0003-2252-1475
Appenteng, Kwame
de Vogel, Stefan http://orcid.org/0000-0001-7318-2288
Seeger, John D. http://orcid.org/0000-0002-8020-3144
Enger, Cheryl
Seeger, John
Hoffman, Veena
Phiri, Kelesitse
Hallas, Jesper
Olesen, Morten
Kristiansen, Nina Sahlertz
Bahmanyar, Shahram
Linder, Marie
Kieler, Helle
Odsbu, Ingvild
Arana, Alejandro
McQuay, Lisa
Margulis, Andrea
Perez-Gutthann, Susana
Ziemiecki, Ryan
Bunniran, Su
Suehs, Brandon
Uribe, Claudia
Xu, Yihua
Horter, Libby
Appenteng, Kwame
de Vogel, Stefan
Robinson, Noah Jamie
Xue, Songlin
Wolfram, Josie
Steup, Achim
Giese-Pagac, Jena
van Aarle, Raymond
Sheth, Neha
Burns, David
Boone, Natalie
Blauwet, Mary Beth
D’Silva, Milbhor
Franks, Billy
Atsma, Willem Jan
Auton, Tim
Garbe, Edeltraut
Ekbom, Anders
Lee, Todd
Weiss, Noel
Rumsfeld, John
Gao, Sara Yuewen
Karslake, Laura
Liu, Nan
Reed, Katherine
Turnbull, Bruce
Yang, Jing
Brooks, Nicole
Mortimer, Kathleen
,
Funding for this research was provided by:
Astellas Pharma Inc.
Article History
Accepted: 30 June 2021
First Online: 8 July 2021
Declarations
:
: This study was funded by Astellas Pharma Inc.
: Cheryl Enger and John D. Seeger are employees of Optum. Veena Hoffman and Kelesitse Phiri were employees of Optum at the time the study was conducted. Veena Hoffman, Kelesitse Phiri, Cheryl Enger and John D. Seeger hold stock in UnitedHealth Group, Optum’s parent company. UnitedHealthcare, a UnitedHealth subsidiary, is a major purchaser of pharmaceutical products. The work was funded with a research contract between Optum and Astellas. Jesper Hallas and Morten Olesen have worked on a project commissioned by Astellas, with funding paid to their employer, the University of Southern Denmark. Nina Sahlertz Kristiansen was an employee of the University of Southern Denmark at the time the study was conducted. The contract granted the research team at the University of Southern Denmark independent publication rights. Marie Linder is an employee of the Centre for Pharmacoepidemiology, Karolinska Institutet. Ingvild Odsbu was an employee of the Centre for Pharmacoepidemiology at the time the study was conducted. The Centre receives grants from several entities (pharmaceutical companies, regulatory authorities and contract research organisations), including Astellas and Pfizer, for performance of drug safety and drug utilisation studies. Andrea V. Margulis, Alejandro Arana and Susana Perez-Gutthann are employees of RTI Health Solutions. RTI Health Solutions is a unit of RTI International, an independent non-profit organisation that conducts work for government, public and private organisations, including pharmaceutical companies. The RTI authors participated in this work in the course of employment as work for hire, pursuant to a contract to conduct an independent research study for a client (Astellas). The authors received no compensation other than their annual salary from their employer. Brandon T. Suehs and Yihua Xu are employees of Humana Healthcare Research, which received funding from Astellas in connection with the performance of this study. Libby Horter was an employee of Humana Healthcare Research at the time the study was conducted. Kwame Appenteng and Stefan de Vogel are employees of Astellas.
: The New England Institutional Review Board (IRB) approved the part of the study conducted by Optum. According to Danish law, register-based studies are exempt from approval by the Danish National Committee on Biomedical Research Ethics. Neither IRBs nor internal ethics committees are used/required at the University of Southern Denmark. The regional ethical board at Karolinska Institutet approved the part of the study conducted by Karolinska Institutet. The RTI International IRB determined that RTI researchers would not be engaged in research with human subjects. With this designation, additional review, approval or exemption by the RTI International IRB was not necessary. The Independent Scientific Advisory Committee for Medicines and Healthcare products Regulatory Agency database research approved the use of the CPRD database by RTI Health Solutions. Advarra (formerly known as Schulman IRB) approved the part of the study conducted by Humana Healthcare Research.
: Not applicable.
: Not applicable.
: This observational study is based on individual patient data maintained by five separate data sources. Therefore, we are not able to make these data available to the public.
: Proprietary code was developed to perform the analyses on the data. The code applied to each data source and is maintained and archived according to the policies specific to each source. Researchers desiring access to the code would be required to obtain permission from the creator.
: All authors provided substantial contributions to the conception or design of the study or the acquisition, analysis or interpretation of the data for the manuscript and the drafting of the manuscript or the revision of the manuscript for important intellectual content. The authors also provided final approval of the version to be submitted and agree to be accountable for all aspects of the manuscript.