AZAHAR Study To Describe Anifrolumab in a Real-World Setting

AstraZeneca

Status: Completed

Conditions: Systemic Lupus Erythematosus (SLE)

Study type: Observational

Funder types: Industry

Identifiers

NCT06626945

D3461R00080

Details and patient eligibility

About

AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.

The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain.

Full description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by altered immune response with excessive cytokines and antibodies production. Immune response activation and maintained inflammatory status promote a multisystemic dysfunction affecting numerous organs.

Anifrolumab, a monoclonal antibody that binds to type 1 IFN, which it is involved in pathways altered in SLE , blocks its effects. In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE, compared to standard of care. This biologic treatment was marketed in Spain on June 1, 2023. This study aims to describe real world evidence of anifrolumab in Spain since its commercialization.

The primary objective is to describe disease activity (including low disease activity state, (LLDAS)) and clinical remission at the initiation with anifrolumab and every 6 months, up to 18 months, after anifrolumab initiation.

The secondary objectives are:

1. To estimate the flare incidence rate, overall, and considering severe flares only, during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation.
2. To describe SLE treatment, especially the use of corticosteroids (CS), during the previous 12 months before anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
3. To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab.
4. To describe healthcare resources utilization (HRU) for SLE during the previous 12 months before anifrolumab initiation and every 6 months, up to 18 months after anifrolumab initiation.

The exploratory objective is:

To describe organ damage at the anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.

This is an observational retrospective and longitudinal chart review study including adults patients with moderate-severe SLE who initiated treatment with anifrolumab. Baseline data 12 months prior to anifrolumab treatment will be collected, and since anifrolumab initiation, participants will be followed-up until the closest available data to the end of the study (December 31st, 2024).

This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.

The expected sample size is around 120 patients from 20 hospitals in Spain.

Enrollment: 152 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfilled the 2019 EULAR/ACR criteria for SLE at the date of anifrolumab initiation.
• Aged 18 years or older at the date of anifrolumab initiation.
• Have initiated anifrolumab between June 1st, 2023, and May 31st, 2024
• Have at least 12 months of medical history prior to anifrolumab initiation.

Exclusion criteria

• Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).