REDUCTION IN RATE AND RISK
OF ORGAN DAMAGE PROGRESSION
REDUCTION IN RATE
AND RISK OF ORGAN
DAMAGE PROGRESSION
The impact of BENLYSTA was evaluated in a real-world analysis of organ damage progression.
REDUCTION OF ORGAN DAMAGE PROGRESSION1
Reduction of organ damage progression based on mean change in organ damage (SDI) from baseline to Year 5*
Primary endpoint
Real-world, post-hoc, propensity score-matched (PSM) analysis. Results are descriptive. See study design for data limitations.
SDI = SLICC/ACR Damage Index; ST = standard therapy; TLC = Toronto Lupus Cohort.
* Includes all patients with ≥5 years of follow-up.
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What was the study design?
Study design1
A post-hoc, PSM comparative analysis was performed to assess the difference in organ damage (SDI) progression between patients in BLISS-76 LTE* and from the TLC.
KEY LIMITATIONS OF THIS PSM STUDY1
- Post-hoc analysis
- Patients matched based on known variables only
- Patients could not be matched by year of entry into the study
- Differences in patient populations
LTE = long-term extension; PSM = propensity score matching; ST = standard therapy; TLC = Toronto Lupus Cohort.
* To be eligible, patients on BENLYSTA had to be in the United States; regimen was BENLYSTA IV 10 mg/kg + ST.
† Chosen based on its size, the extent of organ damage in patients, and the severity of disease activity. Regimen was ST alone.
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What patient characteristics were used in the PSM analysis?
PSM: A method to match and compare patients from different studies1
Patients are matched based on propensity scores calculated using the 17 predictors of organ damage listed below:
Once matched, any observed differences between patients are presumed to be a result of the treatment.
ACR = American College of Rheumatology; PSM = propensity score matching; SDI = SLICC/ACR Damage Index;
SLE = systemic lupus erythematosus; SLEDAI = SLE Disease Activity Index.
REDUCTION IN RATE OF ORGAN DAMAGE PROGRESSION1
Annual probability of progression is based on the increase in SDI score per year
Secondary endpoint
Real-world, post-hoc, propensity score-matched analysis. Results are descriptive. See study design for data limitations.
CI = confidence interval; HR = hazard ratio; SDI = SLICC/ACR Damage Index; ST = standard therapy.
* Based on SDI score increases per year in patients with ≥1 year follow up.
Additional Resources
