Last updated: 01/30/2025 05:40:23

Benlysta Effectiveness

GSK study ID
214140
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: A Retrospective Observational Study Using Real-World Data on the Effectiveness of Belimumab in a Real-World Clinical Practice Setting of Rheumatology Network Providers
Trial description: Belimumab (Benlysta), a biologic therapy that inhibits B cell stimulator, is Food and Drug Administration (FDA)-approved for systemic lupus erythematosus (SLE) and lupus nephritis (LN), along with standard care.
This study aims to examine treatment data for patients with SLE under the care of the United States (US) community rheumatology practitioners, to understand patterns of oral corticosteroids (OCS) use before and during treatment with belimumab.
This study will be a pre-post, retrospective cohort study utilizing data from the Patient-Important Outcomes Data Repository (PIONEER)-Rheumatology database.
The first prescription or treatment for belimumab between January 1, 2012 and June 30, 2021 (e.g., the identification period) will be defined as the index date for the individual patient.
The 180-day period preceding the index date, also referred to as “Period 1.” The pre-index period will be used to describe baseline demographics, clinical characteristics, and utilization of prescription drugs.
The 360-day period, separated into “Period 2, “which covers the index date through 180 days, and “Period 3,” which covers 181 through 360 days after belimumab initiation. The post-index period will be used to describe clinical characteristics and OCS utilization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in proportion of patients receiving OCS from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in the total prednisone equivalent dose per patient from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in total number of OCS days supplied per patient from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in mean daily prednisone equivalent dose for days supplied per patient from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in daily prednisone equivalent dose for days possible per patient from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in proportion of patients with less than or equal to (≤) 5 milligram (mg) prednisone equivalents daily for days supplied from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in proportion of patients with ≤5 mg prednisone equivalents daily for days possible

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in proportion of patients with ≤7.5 mg prednisone equivalents daily for days supplied from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Change in proportion of patients with ≤7.5 mg prednisone equivalents daily for days possible from pre and post-index periods

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Secondary outcomes:

Disease activity scores

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Kidney and Liver function

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Inflammatory Markers

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Blood Glucose

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Antinuclear antibodies (ANA)

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Anti-double stranded Deoxyribonucleic Acid (Anti-asDNA)

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Cyclic citrullinated peptide (CCP)

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

Rheumatoid Factor

Timeframe: At pre-index period (-180 to -1 days) and post-index periods (up to 360 days)

SLE-adjusted Charlson Comorbidity Index (CCI)

Timeframe: At pre-index period (-180 to -1 days)

SLICC/ACR Systemic Damage Index (SDI) Medical Conditions

Timeframe: At pre-index period (-180 to -1 days)

SLE severity

Timeframe: At pre-index period (-180 to -1 days)

Other Rheumatic Diseases

Timeframe: At pre-index period (-180 to -1 days)

Interventions:
  • Drug: Belimumab
    • Enrollment:
    0
    Primary completion date:
    2022-05-12
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Karen Worley, Scott Milligan, Bernard Rubin. Steroid-sparing effect of belimumab: results from a retrospective observational study of real-world data. Lupus science & medicine. 2023-12-22;10(2) DOI:10.1136/lupus-2023-001024 PMID: 38135455
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    October 2022 to December 2022
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Greater than or equal to (≥) 1 diagnosis code of SLE (International Classification of Diseases [ICD]-9-clinical modification [CM]: 710.0x; ICD-10-CM: M32, M32.1x, M32.8, M32.9) recorded on 2 different occasions separated by at least 30 days
    • Initiated belimumab (new users) between January 1, 2012 and June 30, 2021
    • Discontinued belimumab before 180 days post-index
    • Diagnosis of drug-induced Lupus at any point over the individual’s observation period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Greater than or equal to (≥) 1 diagnosis code of SLE (International Classification of Diseases [ICD]-9-clinical modification [CM]: 710.0x; ICD-10-CM: M32, M32.1x, M32.8, M32.9) recorded on 2 different occasions separated by at least 30 days
    • Initiated belimumab (new users) between January 1, 2012 and June 30, 2021
    • At least 18 years of age as of the index date
    • At least 180 days of data available prior to belimumab initiation (back to July 1, 2011)
    • At least 360 days of follow up from belimumab initiation (through Jun 30, 2022)
    • Diagnosed with SLE at any time prior to initiating belimumab
    Exclusion criteria:
    • Discontinued belimumab before 180 days post-index
    • Diagnosis of drug-induced Lupus at any point over the individual’s observation period

    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)
    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
    2022-05-12
    Actual study completion date
    2022-05-12

    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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