Anifrolumab Malignancy and Serious Infections Study

Launched by ASTRAZENECA · May 23, 2025

Keywords

ClinConnect Summary

The Anifrolumab Malignancy and Serious Infections Study is looking at the safety of a medication called anifrolumab for patients with moderate to severe Systemic Lupus Erythematosus (SLE), which is an autoimmune disease that can cause inflammation and damage in various parts of the body. The main goal of this study is to see if taking anifrolumab increases the risk of developing cancers or serious infections compared to patients who are receiving standard treatment for SLE without anifrolumab.

To be eligible for this study, participants must be at least 18 years old and have had a recent flare of their SLE, which means their symptoms have worsened. They should also not have been treated with anifrolumab before the start of the study and must not have had any serious infections or cancers in the past. If you join this study, you will be monitored over time to help researchers understand the effects of anifrolumab. The study is not yet recruiting participants, so there is no need to sign up right now, but it could be an important opportunity for those who are eligible in the future.

Gender

ALL

Eligibility criteria

• 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