Tacrolimus and other immunosuppressive medications have been approved to prevent organ transplant rejection. However, there is limited data about the side effects and health outcomes of pregnant women who use this medication during their pregnancy. This feasibility study aims to understand whether the CPRD Aurum data source contains a large enough number of patients to conduct a full study investigating the health outcomes of pregnant females who have received the drug Tacrolimus or other immunosuppressants either during conception or throughout their pregnancy. The study will specifically investigate the following objectives:
• The number of female patients captured in CPRD Aurum who received a transplant and took Tacrolimus or other immunosuppressive medication before conception or during pregnancy
• The type of transplant received by female patients prior to conception
• The time the female patients received Tacrolimus or other alternative immunosuppressants before conception or during pregnancy.
The results of this study will help inform whether CPRD is a suitable data source to complete a full study to investigate the safety and potential effects of taking Tacrolimus or other immunosuppressive therapies when pregnant or trying to get pregnant.
This feasibility study aims to assess the potential of selected data sources in providing adequate sample size to conduct a potential safety study evaluating pregnancy outcomes after exposure to tacrolimus and alternative immunosuppressants. The objectives are as follows:
1. To estimate, in each of the data sources, the count of pregnancies in which the mother is a transplant recipient who had an exposure before conception or during pregnancy to Tacrolimus or alternative immunosuppressants
2. To describe the type of transplantation (renal, liver, heart, or other transplant) among the transplant recipient mothers of the pregnancies assessed in the previous objective
3. To describe the timing of maternal exposure to tacrolimus or alternative immunosuppressants before conception and during pregnancy
This will be a non-interventional multi-country feasibility assessment using longitudinal secondary data from CPRD and sources in other countries to assess exposure to tacrolimus and alternative immunosuppressants before conception and during pregnancy among transplant recipients, considering both maternal and paternal exposure. With pregnancy as the unit of analysis, the results will be counts of pregnancies with maternal exposure to tacrolimus and alternative immunosuppressants, considering the inclusion and exclusion criteria. The index date for each pregnancy will be defined as the date of conception and will determine the start of the observation period for each individual report of pregnancy.
Eligible patients will be identified within the CPRD Aurum Pregnancy registry and data related to their organ transplantation extracted from the Hospital Episode Statistics inpatient and outpatient data as this is a hospital based procedure. Data regarding the patient’s exposure to tacrolimus or alternative immunosuppressants will also be identified within CPRD Aurum. This feasibility will inform the ability to run a full study which will help inform clinical practice guidelines on prescribing tacrolimus and alternative immunosuppressants to transplant patients during pregnancy.
Type of exposure within 6-weeks pre index date or during pregnancy (tacrolimus, alternative immunosuppressive therapies, or concomitant exposure); Timing of exposure (within 6 weeks pre index date, during first, second, or third trimesters of pregnancy); Transplant type
Sophia Fleming - Chief Investigator - IQVIA Ltd ( UK )
Mariana Amaro - Corresponding Applicant - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Claudia Denye - Collaborator - IQVIA - UK
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Karine Marinier - Collaborator - IQVIA Operations France SAS
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
CPRD Aurum Pregnancy Register;HES Admitted Patient Care;HES Outpatient;CPRD Aurum Mother-Baby Link