Last updated: 11/03/2018 23:02:12

Comparative Effectiveness of Belimumab Use among SLE Patients in a Commercially Insured US Population: 2010-2014

GSK study ID
204999
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
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Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Comparative Effectiveness of Belimumab Use among SLE Patients in a Commercially Insured US Population: 2010-2014
Trial description: Systemic lupus erythematosus (SLE) is a complex autoimmune disorder that affects multiple organ systems and characterized by patterns of exacerbations (waxing) and remissions (waning) or persistently active disease. Belimumab was approved by the FDA in March 2011 for the treatment of SLE as add-on therapy to standard of care (SoC).
Belimumab is approved in United States (US) for four years hence it effectiveness, in terms of targeting the right subjects (diagnosed with SLE) and relevant outcomes such as corticosteroid reduction and flare occurrence, is important to payers and providers to assess the value of belimumab treatment in real-world practice.
A retrospective observational systemic lupus erythematosus (SLE) cohort study using a large, national sample of subjects from a commercially insured US population with claims in the Truven MARKETSCAN®. Commercial Database to compare belimumab initiators to immunosuppressant initiators. The comparative effectiveness research (CER) study design and analysis will produce much needed real-world evidence on clinical and economic outcomes for SLE diagnosed subjects, providers and payers.
SLE diagnosed patients in the Truven MARKETSCAN. Commercial Database who initiate belimumab or an immunosuppressant medication during the period of 01 Jan 2010 through 31 Dec 2014 will be evaluated in this retrospective analysis of a US administrative claims database. MARKETSCAN is a registered trademark of Truven Health Analytics Inc.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Duration of Belimumab use in the follow-up period

Timeframe: Up to 35 months

Patterns of belimumab use in the follow-up period

Timeframe: Up to 4 years

Time to belimumab discontinuation in the follow-up period

Timeframe: Up to 4 years

Change in all-cause healthcare resource utilization (HRU) pre- and post-belimumab initiation

Timeframe: Up to 4 years

Change in all-cause healthcare costs pre- and post-belimumab initiation

Timeframe: Up to 4 years

Change in use of systemic Oral Corticosteroids (OCS) pre- and post-belimumab initiation

Timeframe: Up to 4 years

Change in the occurrence of flare (any type or severe separately) pre- and post-belimumab initiation

Timeframe: Up to 4 years

Secondary outcomes:

Change in all-cause healthcare resource utilization in the belimumab cohort vs. IS cohort

Timeframe: Up to 4 years

Change in all-cause healthcare costs in the belimumab cohort vs. IS cohort

Timeframe: Up to 4 years

Change in use of OCS in the belimumab cohort vs. IS cohort

Timeframe: Up to 4 years

Change in flare occurrence in the belimumab cohort vs. IS cohort

Timeframe: Up to 4 years

Change in flare-associated healthcare utilization and costs in the belimumab cohort vs. IS cohort

Timeframe: Up to 4 years

Interventions:
  • Drug: Belimumab
  • Drug: Active comparator/ immunosuppressants
    • Enrollment:
    700
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Systemic Lupus Erythematosus
    Product
    azathioprine, belimumab, cyclophosphamide, methotrexate, mycophenolate mofetil, rituximab
    Collaborators
    Not applicable
    Study date(s)
    November 2015 to October 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 Year
    Accepts healthy volunteers
    none
    • US adult subjects, aged 18-64 years at index date
    • Belimumab cohort – at least one infusion with belimumab during the observation period. First occurrence of belimumab infusion is the index date, with a minimum of a 6 month (183 days) history of no belimumab exposure prior to the index date
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • US adult subjects, aged 18-64 years at index date
    • Belimumab cohort – at least one infusion with belimumab during the observation period. First occurrence of belimumab infusion is the index date, with a minimum of a 6 month (183 days) history of no belimumab exposure prior to the index date
    • IS cohort – new initiation of an IS medication during the observation period, first occurrence is the index date For IS naïve: minimum of 183 days without a prescription/administration for any of the IS drugs of interest prior to initiation of an IS medication; For IS add-on or switch: a different IS medication added to the SLE treatment regimen that was not prescribed in the preceding 183 days or switching from one IS medication to another IS medication, and the new IS medication was not prescribed in the preceding 183 days
    • Confirmed diagnosis of SLE on or prior to the index date
    • SLE confirmatory diagnosis will be based on literature and the first International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for SLE (710.0x) must occur on or prior to the index date, Two or more (>=2) claims by any physician with the relevant SLE ICD-9 code (710.0x), provided the 2 billing events were at least 2 (>=2) months apart (60 days or >=60) and no longer than 12 (<=12)months apart, or More than 1 (>1) claim for SLE diagnosis (710.0x) by a rheumatologist or internist, or For the hospitalization data, cases were defined based on at least 1 (>=1) discharge diagnosis for SLE diagnosis (710.0 xs).
    • Minimum 6 months (183 days) history prior to the index date defined as the baseline period
    • Continuous enrollment during the baseline period defined as a 0 day gap for both pharmacy and medical coverage throughout the entire observation period
    • The belimumab and IS initiator cohorts are not mutually exclusive for the as-treated methods described for the essential analyses. Throughout the observation period, subjects will be evaluated for inclusion in each cohort. If specific criteria are met, subjects may be eligible for inclusion in both cohorts during the observation period
    • The follow-up period will continue until the first occurrence of any of the following, which will be reported as right-censored data: Loss of pharmacy or medical benefits; Disenrollment from the database; Death; End of observation period
    Exclusion criteria:
    • None

    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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    Scientific result summary
    Available language(s): English
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    Protocol
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2016-27-10

    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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