Anifrolumab Malignancy and Serious Infections Study (SIMA)

AstraZeneca

Status: Not yet enrolling

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Anifrolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07000110

D3461R00046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,506 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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