Anifrolumab Malignancy and Serious Infections Study

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT07000110
• Lead Sponsor: AstraZeneca

Brief Summary

This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Detailed Description

This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study Start: 2025-05-31
• Study First Posted: 2025-06-02
• Last Update Posted: 2025-06-02
• Primary Completion: 2031-11-30
• Study Completion: 2031-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3506

Inclusion Criteria

• First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date
• A minimum data availability of 12 months prior to index date
• Age ≥18 years at index date
• SLE severity: patients with moderate to severe SLE at index date
• SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date

Exclusion Criteria

• A diagnosis of any malignancy prior to index date
• A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date
• Organ or bone marrow transplant procedure prior to index date
• A diagnosis of serious infection in the previous 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignancies	Indexdate to November 2031	Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source
Serious infection	Indexdate to November 2027	Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death
Infections leading to hospitalisation	Index date to November 2027	Infection diagnosis as a part of a hospitalization episode, use of IV antimicrobials, or death, or infection diagnosis in primary or secondary care settings up to 7 days before hospitalization
Infection-related death	Indexdate to November 2027	Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month

Secondary Outcome Measures

Name	Time	Method
Specific types of malignancies	Indexdate to November 2031	Haematologic, solid and skin malignancies
Serious infection components	Indexdate to November 2027	Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death
Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)	Indexdate to November 2027