Last updated: 10/27/2025 19:10:08
Impact of Earlier Belimumab Use for Treatment of Systemic Lupus Erythematosus (SLE) on Clinical and Economic Outcomes in a Real-world Population
GSK study ID
300020
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: Evaluating the Impact of Earlier Use of Belimumab for the Treatment of SLE on Clinical and Economic Outcomes in a Real-World Population
Trial description: This study will evaluate if starting belimumab earlier improves outcomes compared to starting it after using immunosuppressants (IS) in participants with SLE. Medical and claims data from Komodo Research Database (KRD+) from 01 January 2016 to 30 June 2024 or most recently available data will be used. Participants will be assigned to either an early initiating cohort or a late initiating cohort. Index date will be the date of first belimumab claim. The 12-month period before this date is IS identification period. If a participant used IS during this period, they will be assigned to late cohort; if not, they will be in early cohort. There will be 12-month baseline period before IS initiation date for late cohort and before “shadow date” for early cohort. Shadow date will be start date of a new non-IS SLE-related treatment or increased oral glucocorticoids (OGC) dose. Participants will be observed from index date until end of eligibility or data availability, whichever comes first.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Combined Rate of Moderate and Severe SLE Flares Per Participant Year (PPY)
Timeframe: Up to 60 months after belimumab initiation
Secondary outcomes:
Overall Rate of SLE Flares PPY
Timeframe: Up to 60 months after belimumab initiation
Rate of Mild SLE Flares PPY
Timeframe: Up to 60 months after belimumab initiation
Percentage of Participants Categorized by SLE Disease Severity
Timeframe: In the 12 months following belimumab initiation
Average Daily Dose (ADD) of OGC
Timeframe: From belimumab initiation through 6 months, 7 through 12 months, 13 through 18 months, and 19 through 24 months after belimumab initiation
Time to New Onset Organ Damage, Overall and By Each Organ Domain
Timeframe: Up to 60 months after belimumab initiation
Percentage of Participants with New-Onset Organ Damage, Overall and By Each Organ Domain
Timeframe: Up to 60 months after belimumab initiation
Annualized Flare-related Healthcare Costs for Moderate and Severe Flares PPY
Timeframe: Up to 60 months after belimumab initiation
Annualized All-cause Healthcare Costs, Overall PPY
Timeframe: Up to 60 months after belimumab initiation
All-cause Healthcare Costs, Stratified by Baseline Disease Severity
Timeframe: In the 12 months following belimumab initiation
Annualized All-cause Healthcare Costs Stratified by ADD of OGC, PPY
Timeframe: Up to 60 months after belimumab initiation
Annualized New-Onset Organ Damage Healthcare Costs, Overall and By each Organ Domain, PPY
Timeframe: Up to 60 months after belimumab initiation
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-26-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
July 2025 to December 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of SLE (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]) before the index date (date of belimumab initiation) based on
- Greater than or equal to (>=) 2 outpatient (OP)/emergency department (ED) medical claims, OR
- Participants in the early initiating cohort without a valid shadow date (i.e., those who did not newly initiate a non-IS SLE-related treatment [OGC or antimalarials] or a dose escalation of OGC during the IS identification period)
- Diagnosis of drug-induced lupus (ICD-10-CM) any time before the index date based on at least one OP, IP, or ED claim
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of SLE (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]) before the index date (date of belimumab initiation) based on
- Greater than or equal to (>=) 2 outpatient (OP)/emergency department (ED) medical claims, OR
- Greater than or equal to (>=) 1 in-patient (IP) claim
- Participants with >=1 claim for intravenous (IV) or subcutaneous (SC) belimumab (for the early initiator cohort) or belimumab and IS (for the late initiator cohort) after the diagnosis of SLE
- Age >=18 years old on the index date
- Participants with >=24 months of continuous enrollment before index date
- Participants with >=12 months of continuous enrollment after index date
- No IS use during the 12-month IS washout period (i.e., the 12-month period before IS identification period)
- For all landmark analyses: continuous enrollment through the end of the respective assessment window
Exclusion criteria:
- Participants in the early initiating cohort without a valid shadow date (i.e., those who did not newly initiate a non-IS SLE-related treatment [OGC or antimalarials] or a dose escalation of OGC during the IS identification period)
- Diagnosis of drug-induced lupus (ICD-10-CM) any time before the index date based on at least one OP, IP, or ED claim
- Participants in the late initiating cohort who initiated >= 2 different IS during the IS identification period
- Diagnosis of Lupus Nephritis (LN) at any time prior to the index date based on >=2 OP/ED medical claims OR >=1 IP claim
- Any use of a biologic indicated for SLE other than belimumab in the 12 months prior to the index date
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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