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Dosing & Administration
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Consider BENLYSTA earlier to improve long-term treatment outcomes
Up to 50% of patients with SLE experience permanent organ damage within 5 years of diagnosis based on SDI. In a post hoc, propensity score-matched analysis, BENLYSTA + standard therapy was associated with reduced organ damage accrual.1,2
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PSM is a post hoc analysis and the data should be viewed in the context of the following:2
PSM can only match patients based on known variables
Non-observable differences may cause some degree of residual confounding.
Patients could not be matched by year of entry
Adding BENLYSTA IV reduced organ damage (SDI) at year 5 vs. standard therapy2
Overall rates of mortality and AESIs were similar between groups, except for serious depression and serious infusion/hypersensitivity reactions.6
IV = intravenous; SC = subcutaneous; C-SSRS = Columbia-Suicide Severity Rating Scale; NMSC = non-melanoma skin cancer
* Study subjects included in BASE study had a diagnosis of SLE by American College of Rheumatology (ACR) criteria, and were autoantibody-positive and on stable standard therapy. The primary endpoint was incidence of all-cause mortality, serious infections, non-serious opportunistic infections and infections of interest, malignancies, psychiatric events, suicidality, serious infusion and hypersensitivity reactions, and serious adverse events.
† Treatment-emergent suicidal ideation/behaviour was assessed in patients with ≥1 on-treatment and a pre-treatment C-SSRS assessment (placebo: n=1986, belimumab: n=1972).
Magnitude of year-to-year organ damage progression2
Secondary endpoint
The proportion of SDI score increases ≥2 over any given year of follow-up was 30.56% (n=22/72) for standard therapy vs. 6.06% for BENLYSTA (n=2/33, P=0.006).*
Among patients with SDI score increases.
Difference in time to organ damage progression in patients with ≥1 year of follow-up2
Overall rates of mortality and AESIs were similar between groups, except for serious depression and serious infusion/hypersensitivity reactions.6
IV = intravenous; SC = subcutaneous; C-SSRS = Columbia-Suicide Severity Rating Scale; NMSC = non-melanoma skin cancer
* Study subjects included in BASE study had a diagnosis of SLE by American College of Rheumatology (ACR) criteria, and were autoantibody-positive and on stable standard therapy. The primary endpoint was incidence of all-cause mortality, serious infections, non-serious opportunistic infections and infections of interest, malignancies, psychiatric events, suicidality, serious infusion and hypersensitivity reactions, and serious adverse events.
† Treatment-emergent suicidal ideation/behaviour was assessed in patients with ≥1 on-treatment and a pre-treatment C-SSRS assessment (placebo: n=1986, belimumab: n=1972).
Long-term data: Study design2
Propensity score-matched analysis of organ damage in pooled BLISS-LTE trials vs. the Toronto Lupus Cohort.
PSM identifies patients that are clinically and demographically comparable from two different studies over the same time period.
Treatment groups2
LTE = long-term extension; PSM = propensity score matching; SLEDAI-2K = SLE Disease Activity Index-2000; SoC = standard of care
Propensity score matching (PSM)
PSM is a method to pair similar patients from independent studies based on their propensity score.2
Based on literature review, expert feedback and data availability, the following predictors of organ damage were used in the PSM analysis:
Treatment arms
- BENLYSTA SC 200 mg + standard therapy (n=556)
- Control arm: standard therapy + placebo (n=280)
Treatment arms
- BENLYSTA SC 200 mg + standard therapy (n=556)
- Control arm: standard therapy + placebo (n=280)
BENLYSTA: Designed with your patients in mind
References
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- This is a link
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