Last updated: 01/29/2025 10:00:14

Belimumab effectiveness for Systemic Lupus Erythematosus (SLE) in the United States (US)

GSK study ID
217377
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-World Effectiveness of Belimumab in Patients with Systemic Lupus Erythematosus in the United States
Trial description: The goal of this study is to assess the real-world effectiveness of belimumab, among treatment adherent participants with SLE versus those treated with standard of care in the US. The real-world insight gained would help healthcare decision-makers in differentiating belimumab from other treatment options for SLE.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of moderate/severe SLE flares per patient-year

Timeframe: Up to 24 months

Secondary outcomes:

Number of participants with moderate/severe, mild SLE disease severity

Timeframe: Up to 24 months

Number of participants with oral corticosteroid (OCS) use

Timeframe: Up to 24 months

Number of participants with cumulative OCS dose

Timeframe: Up to 24 months

Number of participants with average daily OCS dose

Timeframe: Up to 24 months

Number of participants with OCS use >900 milligrams over 6 months

Timeframe: Up to 6 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-10-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2021 to June 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion Criteria :
  • Both cohorts:
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria : Both cohorts:
  • Greater than or equal to 6 months of continuous health plan enrollment prior to the index date (Baseline period)
  • Greater than or equal to 24 months of continuous health plan enrollment following the index date (follow-up period)
  • Diagnosis of SLE during the Baseline period or on the index date based on: >= 2 outpatient (OP) medical claims in any position; or >= 1 inpatient/emergency department (IP/ED) claim in any position
  • Greater than or equal to 18 years of age at the index date. Belimumab Adherer Cohort:
  • Evidence of belimumab treatment between 01-Jan- 2012 and 31-Mar-2018 with PDC >=80 percent (%) over the 24-month post-index period.
  • The index date will be defined as the date of the first claim (dispensing or administration) for belimumab; participants will be required to only use the belimumab Intravenous (IV) formulation on the index date and during the 24-month post-index period (i.e., participants using the belimumab subcutaneous formulation will be excluded). Belimumab Non-User Cohort:
  • Evidence of SOC treatment for SLE between 01-January-2012 and 31-March-2018. The index date will be selected among all SOC treatment initiation date (i.e., among participants first claim for an nonsteroidal anti-inflammatory drugs [NSAID], immunosuppressant, corticosteroid, or antimalarial)
  • Greater than or equal to 2 dispensings/treatments of any one of the following standard treatment regimens for SLE, at least 6 months apart over the 24-month post-index period; Corticosteroids, NSAIDs, Antimalarials, and Immunosuppressants. Exclusion Criteria: Both Cohorts:
  • Greater than or equal to 1 medical claim with a diagnosis of drug-induced SLE any time prior to or on the index date.
  • Greater than or equal to 2 diagnoses of renal conditions during the Baseline period or on the index date. Belimumab Adherer Cohort:
  • Greater than or equal to 1 dispensing of belimumab subcutaneous formulation on the index date or during the 24-month post-index period Belimumab Non-User Cohort:
  • Greater than or equal to 1 dispensing of belimumab at any time during the treatment identification period (01-Jan-2012 to 31-Mar-2018).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2022-10-06
Actual study completion date
2022-10-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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