Systemic Lupus Erythematosus
Conditions
Keywords
chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), post Marketing Requirements (PMR) study, pregnancy, Systemic Lupus Erythematosus
Brief summary
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
Detailed description
The anifrolumab PRIM program is a supplementary program which utilizes enhanced collection of secondary data from reported anifrolumab-exposed pregnancies collected as part of AstraZeneca's PV system. Initial information about the exposed pregnancy will be collected through the pregnancy report submitted by anifrolumab treated patients or HCPs to the AstraZeneca PV database. Pregnancy outcome information will be collected in close proximity to the planned delivery. Additional follow-up and outcome information will be collected 12 months after delivery. For PV reports of exposed pregnancies that have already had a pregnancy outcome at the time of initial report (retrospective cases), initial characteristics, pregnancy outcome, and any available infant health information will be collected at the time of the initial report. Targeted follow-up checklists and guidance documents will ensure that PV data collected for anifrolumab-exposed pregnancies are as complete as possible and have been mapped for pre-specified analytic variables that will be used to evaluate the safety of anifrolumab exposure for pregnancy and infant outcomes.
Interventions
DRUGAnifrolumab
Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor,which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index,compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022,respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.
Sponsors
AstraZeneca
PPD Development, LP
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Currently or recently (within 1 year of pregnancy outcome) pregnant * Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception
Exclusion criteria
* Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major congenital malfunctions | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | The primary objective of the PRIM program is to estimate the proportion of anifrolumab-exposed pregnancies with major congenital malformations (MCMs) associated with exposure to anifrolumab during pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor congenital malformations | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | To estimate the proportion of anifrolumab-exposed pregnancies with minor congenital malformations associated with exposure to anifrolumab during pregnancy. |
| Adverse pregnancy outcomes | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | To estimate the proportion of anifrolumab-exposed pregnancies with adverse pregnancy outcomes and adverse birth outcomes associated with exposure to anifrolumab during pregnancy. |
| Frequency of adverse pregnancy and birth outcomes | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | To estimate the frequency of adverse pregnancy and birth outcomes associated with exposure to anifrolumab during pregnancy and adverse effects on immune system development in infants with follow-up of up to one year of age. |
Countries
Sweden
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORSyd Philips
PPD Miami, US
Outcome results
None listed