Anifrolumab Malignancy and Serious Infections Study

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07000110

Acronym

SIMA

Enrollment

3506

Registered

2025-06-02

Start date

2026-01-26

Completion date

2031-11-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

malignancies, infections, anifrolumab

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

Interventions

DRUGAnifrolumab

Anifrolumab prescribed per local practice

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Denmark, France, Germany, Spain

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com1-877-240-9479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026