Anifrolumab Malignancy and Serious Infections Study

NCT07000110 | Recruiting

• 1 other identifier: D3461R00046
• Study Type: observational
• Target: 3,195
• Locations: 4 countries
• Sites: 4

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.

Conditions

Systemic Lupus Erythematosus

Keywords

malignancies, infections, anifrolumab

Outcome Measures

Primary Outcomes (4)

• Malignancies

  Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source

  Indexdate to November 2031

• Serious infection

  Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death

  Indexdate to November 2027

• Infections leading to hospitalisation

  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

  Index date to November 2027

• Infection-related death

  Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month

  Indexdate to November 2027

Secondary Outcomes (3)

• Specific types of malignancies

  Indexdate to November 2031

• Serious infection components

  Indexdate to November 2027

• Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)

  Indexdate to November 2027

Interventions

Anifrolumab DRUG

Anifrolumab prescribed per local practice

Also known as: Saphnelo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care (SOC) who do not initiate anifrolumab.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• IQVIA Pty Ltd: collaborator

Study Sites (4)

Research Site

Copenhagen, 23000, Denmark

RECRUITING

Research Site

Charenton-le-Pont, 94220, France

RECRUITING

Research Site

Essen, 45128, Germany

RECRUITING

Research Site

Barcelona, 08007, Spain

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Neoplasms; Infections

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 2, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): November 30, 2031
• Study Completion (Estimated): November 30, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

FR (1); DE (1); DK (1); ES (1)