The Anifrolumab PRIM Program (PRIM)

Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Anifrolumab

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Sweden
  • Södertälje, Sweden
    • Recruiting
    • Reseach Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All pregnancies exposed to anifrolumab and reported to the AstraZeneca pharmacovigilance database on or after the initiation of the PRIM program, regardless of when the pregnancy outcome was ascertained.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Anifrolumab exposed pregnancies; The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.

Drug: Anifrolumab; 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.; Other Names: Saphnelo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major congenital malfunctions	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.	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor congenital malformations	To estimate the proportion of anifrolumab-exposed pregnancies with minor congenital malformations associated with exposure to anifrolumab during pregnancy.	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Adverse pregnancy outcomes	To estimate the proportion of anifrolumab-exposed pregnancies with adverse pregnancy outcomes and adverse birth outcomes associated with exposure to anifrolumab during pregnancy.	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Frequency of adverse pregnancy and birth outcomes	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.	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: PPD Development, LP
• Investigators: Principal Investigator: Syd Philips, PPD Miami, US

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): April 15, 2031
• Study Completion (Estimated): April 15, 2031

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; Systemic Lupus Erythematosus; corticosteroids; immunosuppressants; chronic autoimmune disease; human monoclonal antibody (IgG1ƙ mAb); post Marketing Requirements (PMR) study
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; anifrolumab
• Other Study ID Numbers: D3461R00090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No