Anifrolumab Malignancy and Serious Infections Study

N/ANot Yet RecruitingNCT07000110

AstraZeneca3,506 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,506

Conditions

Systemic Lupus Erythematosus

Interventions

AnifrolumabDRUG

Anifrolumab prescribed per local practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Malignancies

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

Time frame: Indexdate to November 2031

Serious infection

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

Time frame: 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

Time frame: 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

Time frame: Indexdate to November 2027

Secondary Outcomes

Specific types of malignancies

Haematologic, solid and skin malignancies

Time frame: Indexdate to November 2031

Serious infection components

Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death

Time frame: Indexdate to November 2027

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

Time frame: Indexdate to November 2027

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.