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

NCT06485674 | Completed

• 1 other identifier: D3461R00077
• Study Type: observational
• Target: 561
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Anifrolumab; Active Systemic Lupus Erythematosus; Long-Term Organ Damage

Outcome Measures

Primary Outcomes (1)

• SLICC/ACR damage index (SDI) at week 208

  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.

  208 weeks

Secondary Outcomes (4)

• SDI at week 208 by organ damage at baseline

  208 weeks

• Time to first organ damage progression as measured by SDI.

  208 weeks

• Cumulative steroid intake

  208 weeks

• Average daily steroid dose

  208 weeks

Study Arms (2)

Tulip Trial Group

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

Toronto Lupus Cohort Group

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who initiated 300mg of anifrolumab in TULIP-1 or -2 will be included in the active treatment arm of this ECA study. To identify a comparator cohort of patients in the UTLC who would be considered eligible for the TULIP trials, all patients in the UTLC who were active in the database during the study time period (1 January 1995 to 31 December 2023) will be extracted,4 and all key eligibility criteria from TULIP-1 and -2 will be applied to patients in the UTLC.

You may qualify if:

• Aged 18 through 70 years at index date.
• Weight ≥40.0 kg at index date.
• 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.
• SLEDAI-2K score ≥6 points (Table 8 in Appendix) at index date.
• No record of current pregnancy at index date.
• Valid measurement of SDI (Table 9 in Appendix) at index date.

You may not qualify if:

• Corticosteroid dose \>40 mg/day (oral prednisone equivalent) at index date.
• Any record of receiving any biologic agent (e.g., anifrolumab, belimumab, rituximab, abatacept) at index date or within 4 weeks prior to index date.
• Any record of malignancy at any point prior to index date, except skin malignancy ≥1 year prior to index date.
• Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date.
• Serum creatinine \>2.0 mg/dL (or \>181 μmol/L) at index date.
• Record of alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date

Sponsors & Collaborators

• AstraZeneca: lead
• IQVIA Pvt. Ltd: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Research Site

Toronto, Ontario, M5G 1L7, Canada

Location

Related Links

• D3461R00077\_CSR synopsis\_Redacted

Study Officials

• Zahi Touma, Dr

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: May 9, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)