Real-World Evidence
IN A POST HOC, PSM ANALYSIS, BENLYSTA + ST WAS ASSOCIATED WITH REDUCED ORGAN DAMAGE PROGRESSION1
Based on the mean change in SDI from baseline to Year 5*
Primary endpoint
Results are descriptive.
Real-world studies cannot definitively establish causality and are designed to evaluate associations. Limitations are important to interpret results: post hoc, retrospective analysis; patients matched only on known variables; unmatched variables exist (eg, year of entry, patient populations, and data collection vs randomized controlled trials).
PSM = propensity score matching; SDI = SLICC/ACR Damage Index; ST = standard therapy; TLC = Toronto Lupus Cohort.
* Includes all patients with ≥5 years of follow-up.
-
What was the study design?
A PSM analysis was performed
To assess the difference in organ damage progression between BLISS-76 long-term extension (LTE) and patients from the TLC.1
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
† Patients received BENLYSTA 1 mg/kg, 10 mg/kg, or placebo plus ST for up to 76 weeks.
‡ Patients on BENLYSTA 1 mg/kg and placebo in BLISS-76 switched to 10 mg/kg plus ST.
PS = propensity score; SLEDAI = SLE Disease Activity Index.
§For the BLISS-LTE study, the final visit in the parent study was recorded at 76 weeks. Thereafter, SDI was recorded every 48 weeks (“annual” visits). In the TLC, annual visits were defined as the visit closest to each 48-week interval from baseline that deviated no more than 24 weeks from that interval.
-
What were the baseline characteristics?
PSM: A method to match similiar patients from independent studies based on their propensity score1
A patient’s propensity score is based on their clinical demographics and disease characteristics. Using PSM, any observed difference is assumed to be a result of treatment.
Based on literature review, expert feedback, and data availability, 17 variables of known predictors of organ damage were used in the PSM analysis.1
ACR = American College of Rheumatology; SLEDAI = SLE Disease Activity Index.
|| The references for the “Race/ethnicity” variable and the “Baseline SDI” variable were “Caucasian” and “Baseline SDI=0”, respectively.
IN A POST HOC, PSM ANALYSIS, BENLYSTA + ST WAS ASSOCIATED WITH SLOWED ANNUAL RATE OF ORGAN DAMAGE PROGRESSION1
Based on SDI score increases per year¶
Secondary endpoint
Annual rate of organ damage progression
Patients receiving BENLYSTA + ST were 61% less likely to progress to a higher SDI score over any given year of follow-up compared with patients on standard therapy alone.
Hazard ratio (95% CI): 0.39 (0.25, 0.61)
Results are descriptive.
Real-world studies cannot definitively establish causality and are designed to evaluate associations. Limitations are important to interpret results: post hoc, retrospective analysis; patients matched only on known variables; unmatched variables exist (eg, year of entry, patient populations, and data collection vs randomized controlled trials).
¶Includes all patients with ≥1 year of follow-up.
