AZAHAR Study To Describe Anifrolumab in a Real-World Setting

NCT06626945 | Completed

• 1 other identifier: D3461R00080
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 13

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• Flares incidence rate

  12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.

• Anifrolumab adherence

  Up to 18 months since anifrolumab initiation.

• Anifrolumab persistence

  Up to 18 months since anifrolumab initiation.

• Proportion of patients receiving any of dose of corticosteroids (CS)

  Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.

• Annual cumulative dose of CS

  Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months

Other Outcomes (2)

• SLICC/ACR (Systemic Lupus International Collaborating Clinics/American College of Rheumatology) Damage Index for SLE (SDI) score

  At anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.

• Change in SDI score

  From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Barcelona, Spain

Location

Research Site

Granada, Spain

Location

Research Site

Jaén, Spain

Location

Research Site

L'Hospitalet de Llobregat, Spain

Location

Research Site

León, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Mérida, Spain

Location

Research Site

Móstoles, Spain

Location

Research Site

Murcia, Spain

Location

Research Site

Seville, Spain

Location

Research Site

Toledo, Spain

Location

Research Site

Valladolid, Spain

Location

Related Publications (1)

• 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.

  PMID: 39939126 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Josefina Cortés-Hernández, MD, PhD

  Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 4, 2024
• Study Start: February 3, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

ES (13)