Lupus drug anifrolumab under safety microscope: does it raise infection or cancer risk?

NCT ID NCT07000110

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This study watches over 3,000 adults with moderate-to-severe lupus to see if the drug anifrolumab increases the risk of serious infections or cancer compared to standard treatments. No new medicine is given—researchers simply analyze health records from people already prescribed anifrolumab. The goal is to better understand the drug's long-term safety in real-world use.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,506 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Infections neoplasm systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Lupus drug anifrolumab under safety microscope: does it raise infection or cancer risk?

What the study statuses mean