Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus

Recruiting

• Conditions: Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus

• Registration Number: NCT06485674
• Lead Sponsor: AstraZeneca

Brief Summary

This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus (SLE). Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study).

Detailed Description

This is an External Control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active (Systemic lupus erythematosus) SLE. Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study). Patients in the University of Toronto Lupus Clinic will be indexed at the first date of clinical assessment within the patient enrollment period for which they satisfy all eligibility criteria and are receiving at least one eligible SOC treatment (i.e., their 'index assessment') and will be followed up until the earliest occurrence of death, loss to follow-up, UTLC disenrollment, or end of study period.

Study Timeline

• Study Start: 2024-05-09
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

Not provided

Exclusion Criteria

Selected key exclusion criteria from the TULIP trials have been adapted to the RW setting and will be applied to patients in the UTLC. Patients who meet any of the following criteria will be excluded from the study:

1. Corticosteroid dose >40 mg/day (oral prednisone equivalent) at index date.

2. Any record of receiving any biologic agent (e.g., anifrolumab, belimumab, rituximab, abatacept) at index date or within 4 weeks prior to index date.

3. Any record of malignancy at any point prior to index date, except skin malignancy ≥1 year prior to index date.

4. Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date.

5. Serum creatinine >2.0 mg/dL (or >181 μmol/L) at index date.

   The following additional exclusion criteria may be applied to the study cohort at the time of analysis, if it is judged that their application will not significantly reduce the sample size available:

6. Record of alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SLICC/ACR damage index (SDI) at week 208	208 weeks	Organ Damage measured using the SDI . The SDI is designed to assess irreversible damage across 12 organ systems in SLE patients, independently of cause or attribution.

Secondary Outcome Measures

Name	Time	Method
Time to first organ damage progression as measured by SDI.	208 weeks	To estimate effect of anifrolumab plus SOC in TULIP compared to RW SOC on time to first organ damage progression as measured by SDI.
SDI at week 208 by organ damage at baseline	208 weeks	To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on organ damage accrual as measured by SDI at 208 weeks post-treatment initiation in the following subgroups: patients with no organ damage at baseline, and patients with any organ damage at baseline.
Cumulative steroid intake	208 weeks	To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on cumulative steroid intake (prednisone equivalent) up to 208 weeks post-treatment initiation.
Average daily steroid dose	208 weeks	To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on average daily steroid dose (prednisone equivalent) at 208 weeks post-treatment initiation.

Trial Locations

Locations (1)

Research Site; 🇨🇦 Toronto, Ontario, Canada