N/A
N=2,967
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01729455 ↗Enrolled (actual)
2,967
Serious AEs
12.7%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy — 48; 29; 44; 24 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Benlysta (Biological); Standard of Care (SoC) Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy |
48; 29; 44; 24; 167; 65 | — |
| PRIMARY Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy |
0.50; 0.88; 0.55; 0.66; 2.86; 2.33 | — |
| PRIMARY Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy |
0.68; 0.84; 0.53; 0.90; 2.63; 2.52 | — |
| PRIMARY Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy |
0.66; 0.88; 0.48; 0.71; 2.30; 2.59 | — |
| PRIMARY Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy |
0.62; 0.94; 0.50; 0.68; 2.30; 2.38 | — |
| PRIMARY Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy |
0.58; 0.89; 0.60; 0.67; 2.22; 2.45 | — |
| PRIMARY Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy |
0.55; 0.66; 3.21; 2.64; 0.55; 0.88 | — |
| PRIMARY Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy |
0.53; 0.90; 3.01; 2.90; 0.56; 0.63 | — |
| PRIMARY Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy |
0.48; 0.74; 2.81; 3.23; 0.54; 0.81 | — |
| PRIMARY Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy |
0.51; 0.70; 2.80; 3.08; 0.57; 0.86 | — |
| PRIMARY Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy |
0.61; 0.69; 2.70; 3.44; 0.50; 0.87 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Males or females age 18 years or older.
- Have a clinical diagnosis of active SLE.
- Current or history of autoantibody-positive SLE.
- Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
- Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.
Exclusion Criteria
- Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used.
- Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.
- Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
- Participants only receiving an anti-malarial for SLE.
- Participants only receiving steroids for SLE.
Data sourced from ClinicalTrials.gov (NCT01729455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.