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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2022-05-12
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)

No location data available.

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
Finalized
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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