|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
The primary endpoint was the SLE Responder Index-4 (SRI-4) at week 12.
|
31537547 |
2020 |
|
Lupus Erythematosus, Systemic
|
0.100 |
GeneticVariation
|
disease |
BEFREE |
Maintenance of efficacy was assessed using SLEDAI-2K, SLE Responder Index 4 (SRI-4), Physician's Global Assessment, and mucocutaneous and joint disease measures in a modified intention-to-treat population.
|
31769212 |
2019 |
|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
The Phase IIb, randomized control trial (RCT), double-blind, placebo-controlled study of adults with moderate-to-severe SLE (MUSE trial) showed positive results on the composite primary endpoint SRI-4.
|
31190735 |
2019 |
|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
In the present post-hoc analysis of two clinical trials of belimumab, we investigated two potential outcomes, the Lupus Low Disease Activity State (LLDAS) and clinical SLE disease activity index 2000 (cSLEDAI-2K) zero, in relation to SLE responder index 4 (SRI-4).
|
30571926 |
2019 |
|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
SRI(4) responders achieved significantly greater improvements in clinical outcome measures (including percentages of patients with a ≥ 7-point reduction in SLE Disease Activity Index (SLEDAI)-2000 (2K), British Isles Lupus Assessment Group "A" or "2B" flare rate, and oral corticosteroid reduction to ≤7.5 mg/day; change from baseline in Physician's Global Assessment; and numbers of SLEDAI-2K organ domains with improvement), as well as in patient-reported outcomes (Patient's Global Assessment, Functional Assessment of Chronic Illness Therapy-Fatigue; Short-Form 36 Health Survey Physical Component Summary, Mental Component Summary, Vitality domain scores) vs. nonresponders.
|
29460699 |
2018 |
|
Lupus Erythematosus, Systemic
|
0.100 |
GeneticVariation
|
disease |
BEFREE |
The primary end point was the week 52 SLE Responder Index-6 (SRI-6).
|
29563108 |
2018 |
|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
The primary end point was the SLE responder index 4 (SRI-4) at week 24.
|
29073347 |
2018 |
|
Lupus Erythematosus, Systemic
|
0.100 |
Biomarker
|
disease |
BEFREE |
In contrast to the performance of the SLE Responder Index 4 (SRI-4), the LuMOS revealed significant differences between the active treatment group (1 mg belimumab in the BLISS-76 cohort) and placebo group.
|
29648686 |
2018 |
|
Lupus Erythematosus, Systemic
|
0.100 |
GeneticVariation
|
disease |
BEFREE |
The primary endpoint was proportion achieving SLE Responder Index-5 (SRI-5) improvement at week 52.
|
27471815 |
2017 |
|
Lupus Erythematosus, Systemic
|
0.100 |
GeneticVariation
|
disease |
BEFREE |
SLE Responder Index (SRI-4; primary end point) and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) were assessed at week 24.
|
27672124 |
2017 |