Comparing Anifrolumab to Standard Care for Long-Term Organ Damage in Lupus Patients

Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus (LASER) An External Comparator Arm Study for the TULIP Trials Using the University of Toronto Lupus Clinic Cohort

This study is testing whether adding anifrolumab to standard treatment can help prevent long-term organ damage in adults with active lupus.

Quick facts

• Study type: Observational
• Enrollment: 478 (estimated)
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: anifrolumab, belimumab, rituximab, prednisone
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06485674 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the effects of anifrolumab combined with standard care against real-world standard care on long-term organ damage in adults with moderately to severely active systemic lupus erythematosus (SLE). Patients who have started treatment with anifrolumab will be followed from their treatment initiation date until specific endpoints such as death or loss to follow-up. Additionally, patients from the University of Toronto Lupus Clinic will be monitored from their first clinical assessment during the enrollment period. The study seeks to generate evidence on the effectiveness of anifrolumab in managing organ damage in SLE patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of systemic lupus erythematosus and a SLEDAI-2K score of 6 or higher.

Not a fit: Patients currently on high doses of corticosteroids or those who have received biologic agents recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of anifrolumab in reducing long-term organ damage in lupus patients.

How similar studies have performed: While this approach is based on previous trials, the specific comparison of anifrolumab to real-world standard care in this context is relatively novel.

Eligibility criteria

Inclusion Criteria for UTLC:

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:

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

Where this trial is running

Toronto, Ontario

• Research Site — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Zahi Touma, Dr — University Health Network, Toronto
• Study coordinator: AstraZeneca Clinical Study Information Center

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