Anifrolumab Malignancy and Serious Infections Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-28

Study Completion Date

2031-11-30

Brief Summary

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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.

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Detailed Description

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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

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Anifrolumab

Anifrolumab prescribed per local practice

Intervention Type DRUG

Other Intervention Names

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Saphnelo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No