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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

561 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2025-06-24

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tulip Trial Group

Patients who initiated 300 mg of anifrolumab in TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway)-1 or -2.

No interventions assigned to this group

Toronto Lupus Cohort Group

Participants who received RW Standard Of Care for SLE from the University of Toronto Lupus Clinic (UTLC) registry.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 through 70 years at index date.
2. Weight ≥40.0 kg at index date.
3. Diagnosis of paediatric or adult SLE ≥24 weeks prior to index date using ≥4 of the 11 modified ACR classification criteria at least one of which must be positive antinuclear antibody test, anti-dsDNA antibodies, or anti-Smith antibody elevated to above normal level.
4. SLEDAI-2K score ≥6 points (Table 8 in Appendix) at index date.
5. No record of current pregnancy at index date.
6. Valid measurement of SDI (Table 9 in Appendix) at index date.

Exclusion Criteria

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.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No