Clinical trial NCT06626945: AZAHAR Study To Describe Anifrolumab in a Real-World Setting
Official title: AZAHAR Study. Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo (Anifrolumab) in a Real-World Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus (SLE)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients diagnosed with SLE who attended the specialist's office at the participating hospitals in the study and initiated anifrolumab during the following period, between June 1st, 2023, and May 31st, 2024.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
timeFrame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
measure: Physician Global Assessment (PGA) score
timeFrame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
measure: Changes in SLEDAI-2K score
timeFrame: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
measure: Changes in PGA score
timeFrame: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
measure: Proportion of patients achieving low disease activity state
timeFrame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
measure: Proportion of patients achieving clinical remission
timeFrame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Secondary outcomes:
measure: Flares incidence rate
timeFrame: 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
measure: Anifrolumab adherence
timeFrame: Up to 18 months since anifrolumab initiation.
measure: Anifrolumab persistence
timeFrame: Up to 18 months since anifrolumab initiation.
measure: Proportion of patients receiving any of dose of corticosteroids (CS)
timeFrame: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
measure: Annual cumulative dose of CS
timeFrame: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months
measure: Proportion of patients treated with any biologic treatment
timeFrame: Previous 12 months before anifrolumab initiation.
measure: Proportion of patients treated with any antimalarial medication
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Proportion of patients treated with any immunosuppressive medication
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Hospitalization rate attributable to SLE
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Intensive care unit (ICU) admission rate attributable to SLE
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Emergency room (ER) admission rate attributable to SLE
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Primary care (PC) visits rate attributable to SLE
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
measure: Specialist visits rate attributable to SLE
timeFrame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Other outcomes:
measure: SLICC/ACR (Systemic Lupus International Collaborating Clinics/American College of Rheumatology) Damage Index for SLE (SDI) score
timeFrame: At anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
measure: Change in SDI score
timeFrame: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Locations:
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Merida
country: Spain
facility: Research Site
city: Mostoles
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
Study officials:
affiliation: Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón
name: Josefina Cortés-Hernández, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: