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).
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 Type
OBSERVATIONAL
Enrollment
561
Research Site
Toronto, Ontario, Canada
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.
Time frame: 208 weeks
SDI at week 208 by organ damage at baseline
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 frame: 208 weeks
Time to first organ damage progression as measured by SDI.
To estimate effect of anifrolumab plus SOC in TULIP compared to RW SOC on time to first organ damage progression as measured by SDI.
Time frame: 208 weeks
Cumulative steroid intake
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.
Time frame: 208 weeks
Average daily steroid dose
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.
Time frame: 208 weeks
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