Last updated: 10/22/2024 17:10:09

Costs and Healthcare Resource Utilization Associated with Systemic Lupus Erythematosus (SLE) Flares and Belimumab Utilization Among Patients with SLE

GSK study ID
209422
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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: Costs and Healthcare Resource Utilization Associated with Systemic Lupus Erythematosus (SLE) Flares and Belimumab Utilization Among Patients with SLE
Trial description: SLE is a chronic, multisystem autoimmune disease characterized by diverse clinical manifestations, chronic inflammation, and waxing and waning disease activity. Belimumab is a B-lymphocyte stimulator-specific inhibitor indicated for the treatment of adult subjects with active, autoantibody-positive SLE receiving standard therapy. The healthcare economic information as demonstrated in previous belimumab studies would be valuable for population-based decision makers like third-party payers, managed care organizations, integrated delivery networks, as well as physicians and subjects alike. In this regard, this retrospective analysis is designed to evaluate hospital-based costs and healthcare resource utilization (HCRU) before and after the initiation of intravenous (IV) belimumab for subjects diagnosed with SLE in the United States and from the third-party, commercial payer perspective. This study will use administrative claims data from the Truven Health MARKETSCAN® Commercial Claims and Encounters (Commercial) and Medicare Supplemental claims database. The duration of claims analysis will be from 01 January 2012 through 31 March 2017. The date of the first observed belimumab IV infusion claim between 01 January 2013 and 31 March 2016 (identification period) will be defined as the index date. MARKETSCAN is a registered trademark of Truven Health Analytics.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Total cost of hospital-based service utilization

Timeframe: Up to 5.3 years

Secondary outcomes:

Total number of hospital-based service utilization

Timeframe: Up to 5.3 years

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-31-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Tasneem Lokhandwala, Anna D Coutinho, Christopher F Bell.Retrospective Analysis of Disease Severity, Healthcare Resource Utilization and Costs Among Patients Initiating Belimumab for the Treatment of Systemic Lupus Erythematosus.Clin Ther.2021; DOI: 10.1016/j.clinthera.2021.06.009
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Xcenda
Study date(s)
May 2018 to January 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
  • At least one inpatient claim or non-diagnostic outpatient claim with a diagnosis of SLE between 01 January 2012 and 31 March 2017.
  • Evidence of IV belimumab treatment between 01 January 2013 and 31 March 2016 identified using National Drug Classification (NDC) codes and Healthcare Common Procedure Coding System (HCPCS) codes. The earliest claim date will be the index date.
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one inpatient claim or non-diagnostic outpatient claim with a diagnosis of SLE between 01 January 2012 and 31 March 2017.
  • Evidence of IV belimumab treatment between 01 January 2013 and 31 March 2016 identified using National Drug Classification (NDC) codes and Healthcare Common Procedure Coding System (HCPCS) codes. The earliest claim date will be the index date.
  • Aged >=18 years at index date.
  • At least 24 months of continuous enrolment in the database with medical and prescription drug coverage (at least 12 months before [pre-index period] and 12 months after the index date [post-index period]).
  • No evidence of a lupus nephritis diagnosis, as defined using the following criteria at any time during the pre- or post-index period: >2 inpatient or non-diagnostic outpatient medical claims with a diagnosis of acute or chronic glomerulonephritis (including lupus glomerulonephritis), acute or chronic renal failure, nephritis or nephrotic syndrome (including lupus nephrotic syndrome), renal failure or proteinuria and >2 inpatient or non-diagnostic outpatient medical claims where the service provider is a nephrologist.
  • No evidence of belimumab treatment during the pre-index period.
  • The population meeting all the above criteria will be considered as the intention-to-treat cohort.
  • Subjects with at least 4 IV belimumab infusions in the first 6-months post-index and meeting all the criteria mentioned above will be included in modified intent-to-treat cohort.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
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Protocol
Available language(s): English
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Scientific result summary
Available language(s): English
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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
2019-31-01
Actual study completion date
2019-31-01

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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