AZAHAR Study To Describe Anifrolumab in a Real-World Setting (AZAHAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus (SLE)

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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Research Site
  • Granada, Spain
    • Research Site
  • Jaén, Spain
    • Research Site
  • L'Hospitalet de Llobregat, Spain
    • Research Site
  • León, Spain
    • Research Site
  • Madrid, Spain
    • Research Site
  • Murcia, Spain
    • Research Site
  • Málaga, Spain
    • Research Site
  • Mérida, Spain
    • Research Site
  • Móstoles, Spain
    • Research Site
  • Seville, Spain
    • Research Site
  • Toledo, Spain
    • Research Site
  • Valladolid, Spain
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score	The total score ranges between 0 and 105, with higher scores representing increased disease activity.	At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Physician Global Assessment (PGA) score	PGA ranges from 0 to 3, with 0 representing the total inactivity of the disease and 3 an important activity. An increase of ≥1 score since the last visit is indicative of a flare.	At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Changes in SLEDAI-2K score	Change from baseline in SLEDAI-2K score for consecutive timepoints.	From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Changes in PGA score	Change from baseline in PGA score for consecutive timepoints.	From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Proportion of patients achieving low disease activity state	LLDAS requires all the following criteria to be met: SLEDAI-2K score ≤ 4, with no activity in the major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever).; No new SLEDAI-2K assessed disease activity compared to the previous visit.; PGA score ≤ 1; Prednisone or equivalent dosage ≤ 7.5 mg/day; No non-standard immunosuppressant dosing, with antimalarials allowed.	At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Proportion of patients achieving clinical remission	Clinical remission will be measured as DORIS-21, a composite endpoint including: Clinical SLEDAI score of 0 (no disease activity); PGA <0.5; Prednisolone dose of 5 mg/day or less.; Stable use of antimalarials, immunosuppressives, and biologics.	At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flares incidence rate	Flares is defined as worsening of symptoms based as assessed with a modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI) based on SLEDAI-2K assessment.	12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
Anifrolumab adherence	Proportion of anifrolumab infusions that happen every 18 to 38 days during a certain specified period from first anifrolumab infusion.	Up to 18 months since anifrolumab initiation.
Anifrolumab persistence	Time on treatment until discontinuation or end of follow-up	Up to 18 months since anifrolumab initiation.
Proportion of patients receiving any of dose of corticosteroids (CS)	CS include the following route of administration: oral, subcutaneous, intramuscular or intravenous.	Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Annual cumulative dose of CS	Corticosteroids include the following route of administration: oral, subcutaneous, intramuscular or intravenous.	Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months
Proportion of patients treated with any biologic treatment	Biologic treatment refers to any biologic medication (on-label and off-label) prescribed for SLE.	Previous 12 months before anifrolumab initiation.
Proportion of patients treated with any antimalarial medication	Antimalarial medication prescribed for SLE.	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Proportion of patients treated with any immunosuppressive medication	Immunosuppressive medication prescribed for SLE.	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Hospitalization rate attributable to SLE	Annual hospitalization rate expressed by patient-year	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Intensive care unit (ICU) admission rate attributable to SLE	Annual ICU admission rate expressed by patient-year	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Emergency room (ER) admission rate attributable to SLE	Annual ED admission rate expressed by patient-year	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Primary care (PC) visits rate attributable to SLE	Annual PC visits rate expressed by patient-year	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Specialist visits rate attributable to SLE	Annual specialist visits rate expressed by patient-year	Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLICC/ACR (Systemic Lupus International Collaborating Clinics/American College of Rheumatology) Damage Index for SLE (SDI) score	SDI contains items that should be present for at least 6 months with the exception that manifestations such as myocardial infarction and stroke are recorded once they occur. Damage is defined for 12 organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1), and malignancies (0-2). Damage over time can only be stable or increase, theoretically to a maximum of 47 points. Higher scores indicate higher organ damage.	At anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
Change in SDI score	Change from baseline in SDI score for consecutive timepoints.	From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Josefina Cortés-Hernández, MD, PhD, Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón

Publications and helpful links

General Publications

• Galindo-Izquierdo M, Bahamontes-Rosa N, Sarto-Ferres B, Galvez-Fernandez M, Cortes-Hernandez J. Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol. Lupus Sci Med. 2025 Feb 12;12(1):e001486. doi: 10.1136/lupus-2024-001486.

Helpful Links

• D3461R00080_CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: D3461R00080