Last updated: 09/15/2022 11:50:07
BENLYSTA® real world evidence (RWE): Rheumatology Informatics System for Effectiveness (RISE) Registry
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A retrospective analysis of corticosteroid use amongst Benlysta-treated Systemic Lupus Erythematosus (SLE) patients in the Rheumatology Informatics System for Effectiveness (RISE) Registry
Trial description: Use of corticosteroids remains part of the standard of care approach to management of SLE. However, long-term high dose corticosteroid treatment is well known to contribute to organ damage as well as infections and death. Reduction in steroid use is therefore a key treatment goal. The real-world effectiveness of belimumab (BENLYSTA) intravenous (IV) was observed in a series of observational studies in the United States (US) and elsewhere, including a glucocorticoid dose reduction. No such data are available yet for the belimumab subcutaneous (SC) formulation. The RISE Registry offers a unique opportunity to collect corticosteroid dose on a large sample of belimumab-treated subjects, including detailed prescribing notes from which daily fluctuations in prescribed dose can be derived. This study aims to assess the effect of belimumab on systemic corticosteroid use when used in the routine clinical setting in the US. This is an observational, retrospective cohort study of belimumab-treated SLE subjects in the US RISE registry. Subjects will be identified from the RISE Registry. Only data from RISE practices that have completed the mapping and validation process and confirmed the accuracy of their data will be included in this analysis. The study population will consist of subjects meeting the eligibility criteria with an index date between 01-January-2014 and 30-June-2017 (the inclusion period). The date of first belimumab prescription amongst included subjects will serve as the index date. BENLYSTA is the registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Average daily corticosteroid (prednisone equivalent) dose prescribed to subjects
Timeframe: Up to 6 months (pre-index date and post-index date)
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2020-06-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Nevin Hammam, Michael Evans, Christopher F Bell, Kerry Gairy, Jinoos Yazdany, Gabriela Schmajuk. Evaluating the Use of Glucocorticoids Among Belimumab-Treated Patients With Systemic Lupus Erythematosus in Real-World Settings Using the Rheumatology Informatics System for Effectiveness Registry. ACR Open Rheumatol. 2022;
DOI: 10.1002/acr2.11482
PMID: 35872599
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
American College of Rheumatology
Study date(s)
April 2019 to April 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- At least 18 years old at index date.
- A diagnosis of SLE, defined as at least one encounter with an International Classification of Diseases-9 (ICD-9) 710.0 or ICD-10 M32 (excluding M32.0) diagnosis code in the 6 months prior to index date.
- Switching formulation from belimumab SC to belimumab IV during the study period.
- Subjects may only be included in the study once, at their first index date during the inclusion period. That is, subjects who discontinue belimumab after the index date but thereafter would again meet the study eligibility criteria cannot be re-included.
Inclusion and exclusion criteria
Inclusion criteria:
- At least 18 years old at index date.
- A diagnosis of SLE, defined as at least one encounter with an International Classification of Diseases-9 (ICD-9) 710.0 or ICD-10 M32 (excluding M32.0) diagnosis code in the 6 months prior to index date.
- At least one prescription of belimumab (identified by National Drug Code [NDC]) during the inclusion period.
- Visit history is available for at least 6 months prior to index date and at least 6 months post index date.
- No prescription of belimumab in the 6 months prior to index date.
- Subjects included in the primary analysis have received at least the IV ‘loading’ dose (or SC equivalent); the initial higher (biweekly) frequency of administration in the 6 weeks of treatment. This is defined as: for subjects receiving belimumab IV at the index date, only subjects with at least 3 IV administrations in the 8 weeks including and after index date will be included in the primary analysis; for subjects receiving belimumab SC at the index date, only subjects with at least two prescriptions of SC within the first 8 weeks including and after the index date (one prescription is assumed to reflect 4 SC doses).
Exclusion criteria:
- Switching formulation from belimumab SC to belimumab IV during the study period.
- Subjects may only be included in the study once, at their first index date during the inclusion period. That is, subjects who discontinue belimumab after the index date but thereafter would again meet the study eligibility criteria cannot be re-included.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
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
2020-06-04
Actual study completion date
2020-06-04
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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