The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Age range
18 Years
Sex
ALL
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Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy
Timeframe: Up to 63 Months
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 12 Months
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 24 Months
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 36 Months
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 48 Months
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 63 Months
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 12 Months
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 24 Months
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 36 Months
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 48 Months
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy
Timeframe: Up to 63 Months