Anifrolumab and risk of cancers and serious infections in SLE

A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab

This project will see if adults with moderate-to-severe SLE who start anifrolumab have different rates of cancers and serious infections than similar patients receiving standard care.

Quick facts

• Study type: Observational
• Enrollment: 3195 (estimated)
• Ages: 18 Years to 130 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: anifrolumab
• Locations: 4 sites (Copenhagen and 3 other locations)
• Trial ID: NCT07000110 on ClinicalTrials.gov

What this trial studies

This is a multi-site observational cohort comparison that uses the date of first anifrolumab prescription as an index date to follow patients for malignancies and serious infections. Eligible patients are adults with moderate-to-severe SLE who had at least one flare in the six months before the index date and at least 12 months of prior data, and patients with prior malignancy, HIV/immunodeficiency, transplant, or recent serious infection are excluded. The study compares event rates between those initiating anifrolumab and a matched group receiving standard of care, with statistical adjustment for baseline differences. Data will be drawn from participating European sites and analyzed to estimate relative safety risks in real-world use.

Who should consider this trial

Good fit: Adults (≥18) with moderate-to-severe SLE who experienced at least one flare in the prior six months, who are starting anifrolumab as their first dose during the study period, and who have at least 12 months of prior medical data are the intended participants.

Not a fit: People with prior malignancy, HIV/AIDS or congenital immunodeficiency, prior organ or bone marrow transplant, recent serious infection, or those under 18 or not starting anifrolumab would not meet the criteria and are unlikely to benefit from this study's findings directly.

Why it matters

Potential benefit: If successful, the results could clarify real-world safety risks of anifrolumab and help patients and clinicians make more informed treatment decisions.

How similar studies have performed: Clinical trials and observational safety studies of anifrolumab and other biologics have identified infection risks and provided useful safety signals, but large real-world comparative data specifically on malignancy risk remain limited.

Eligibility criteria

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

Where this trial is running

Copenhagen and 3 other locations

• Research Site — Copenhagen, Denmark (Recruiting)
• Research Site — Charenton-le-Pont, France (Recruiting)
• Research Site — Essen, Germany (Recruiting)
• Research Site — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Systemic Lupus Erythematosus; malignancies, infections, anifrolumab