Last updated: 07/25/2025 14:10:09

Belimumab comparative effectiveness: Systemic Lupus Erythematosus (SLE) outcomes 3-5 years

GSK study ID
217537
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: Comparative Analysis of the Relationship between Earlier Use of Belimumab using Treatment History as a Proxy and Improved Health Outcomes in a Real-World Population
Trial description: The present study will compare clinical and economic outcomes of participants initiating belimumab earlier in their course of treatment versus later, using prior treatment history as proxy for the timing of initiation. The baseline period will be defined as the 12-month period preceding the date of initiation of IS treatment for the late initiating cohort. The observation period will span from the index date to the earliest of end of continuous eligibility or end of data availability, whichever comes first.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants who Discontinued Oral corticosteroids (OCS) with greater than (>) 0 milligrams per day (mg/day) at index date

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Average Daily Dose (ADD) of OCS

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Reduction of ADD of OCS to below 5 mg/day for those with greater than or equal to (>=) 10 mg/day at index date

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Discontinuation or reduction of OCS dosage below 5 mg/day for those with >= 10 mg/day at index date

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Secondary outcomes:

Systemic Lupus Erythematosus (SLE) flare episodes Recorded as per Physician’s Speciality

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Rate of all-cause inpatient (IP) stays over post-index enrolment period

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Rate of all-cause Emergency Department (ED) visits over post-index enrolment period

Timeframe: 12 months (pre-dose) to up to 60 months post-dose)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-30-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Karen H Costenbader, Maral DerSarkissian, Yan Chen, Brendan Rabideau, Karen Worley, Theo Man, Bernard Rubin, S Sam Lim. Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study. Rheumatology and therapy. 2025-Jun-17; doi:10.1007/s40744-025-00774-6 http://dx.doi.org/10.1007/s40744-025-00774-6 PMID: 40528076 DOI: 10.1007/s40744-025-00774-6
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
November 2023 to January 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Diagnosis of Systemic Lupus Erythematosus before or on the index date based on greater than or equal to (>=) 2 outpatient medical claims, or >=1 inpatient/ED claim
  • >= 1 pharmacy claim for intravenous (IV) or subcutaneous (SC) belimumab (for the early belimumab cohort) or belimumab and Immunosuppressant (IS) (for the late belimumab cohort) after the diagnosis of SLE
  • Participants in the early initiating cohort without a valid shadow date (that is, those who did not newly initiate a non-IS SLE-related treatment [Oral Corticosteroids (OCS), biologics, and antimalarials] or a dose escalation of OCS during the IS identification period)
  • Diagnosis of drug-induced lupus any time before the index date based on at least one outpatient, inpatient, or Emergency Department (ED) claim
Inclusion and exclusion criteria
Inclusion criteria:

    Diagnosis of Systemic Lupus Erythematosus before or on the index date based on greater than or equal to (>=) 2 outpatient medical claims, or >=1 inpatient/ED claim

    • >= 1 pharmacy claim for intravenous (IV) or subcutaneous (SC) belimumab (for the early belimumab cohort) or belimumab and Immunosuppressant (IS) (for the late belimumab cohort) after the diagnosis of SLE
    • >= 24 months of continuous enrolment before index date
    • No Immunosuppressant (IS) use during the 12-month IS washout period
Exclusion criteria:

    Participants in the early initiating cohort without a valid shadow date (that is, those who did not newly initiate a non-IS SLE-related treatment [Oral Corticosteroids (OCS), biologics, and antimalarials] or a dose escalation of OCS during the IS identification period)

    • Diagnosis of drug-induced lupus any time before the index date based on at least one outpatient, inpatient, or Emergency Department (ED) claim
    • Any pharmacy claims for belimumab or Janus Kinase (JAK) inhibitor (that is, baricitinib, tofacitinib, upadacitinib, ruxolitinib, and fedratinib) during the 24-month period before index date

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
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
2024-30-01
Actual study completion date
2024-30-01

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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