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.
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
152
Research Site
Barcelona, Spain
Research Site
Granada, Spain
Research Site
Jaén, Spain
Research Site
L'Hospitalet de Llobregat, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Research Site
León, Spain
Research Site
Madrid, Spain
Research Site
Málaga, Spain
Research Site
Mérida, Spain
Research Site
Móstoles, Spain
Research Site
Murcia, Spain
...and 3 more locations
Time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
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.
Time frame: 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.
Time frame: Up to 18 months since anifrolumab initiation.
Anifrolumab persistence
Time on treatment until discontinuation or end of follow-up
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Previous 12 months before anifrolumab initiation.
Proportion of patients treated with any antimalarial medication
Antimalarial medication prescribed for SLE.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.