Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus
Conditions
Keywords
Anifrolumab, Active Systemic Lupus Erythematosus, Long-Term Organ Damage
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.
Interventions
None listed
Sponsors
AstraZeneca
IQVIA Pvt. Ltd
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORZahi Touma, Dr
University Health Network, Toronto
Outcome results
None listed