Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus

Shereen Oon, Molla Huq, Vera Golder, Pei Xuan Ong, Eric F. Morand, Mandana Nikpour

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Abstract

Objective: We evaluated the discriminant capacity of the Lupus Low Disease Activity State (LLDAS) in post-hoc analysis of data from the BLISS-52 and BLISS-76 trials of belimumab in systemic lupus erythematosus (SLE). Methods: LLDAS attainment, discrimination between belimumab and placebo arms, and the effects in subgroups with high disease activity at recruitment were evaluated at week 52 using appropriate descriptive statistics, Ï ‡2 test and logistic regression. Results: At week 52, for belimumab 10 mg/kg, 17.0% and 19.3% of patients who achieved a Systemic Lupus Erythematosus Responder Index-4 also attained LLDAS in BLISS-52 and BLISS-76, respectively. Significantly more patients attained LLDAS on belimumab 10 mg/kg compared with placebo (12.5% vs 5.8%, OR 2.32, p=0.02 for BLISS-52; 14.4% vs 7.8%, OR 1.98, p=0.04 for BLISS-76). In a subgroup analysis, the difference in week 52 LLDAS attainment between belimumab 10 mg/kg and placebo was greater in patients who had higher disease activity at baseline, compared with the overall group. Conclusions: LLDAS was able to discriminate belimumab 10 mg/kg from placebo in the BLISS-52 and BLISS-76 trials. Our findings support the validity of LLDAS as an outcome measure in SLE clinical trials.

Original languageEnglish
Pages (from-to)29-633
Number of pages5
JournalAnnals of the Rheumatic Diseases
Volume78
Issue number5
DOIs
Publication statusPublished - 1 May 2019

Keywords

  • belimumab
  • LLDAS
  • lupus

Cite this

@article{0ed07342dca6446fb9d48ff96447e314,
title = "Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus",
abstract = "Objective: We evaluated the discriminant capacity of the Lupus Low Disease Activity State (LLDAS) in post-hoc analysis of data from the BLISS-52 and BLISS-76 trials of belimumab in systemic lupus erythematosus (SLE). Methods: LLDAS attainment, discrimination between belimumab and placebo arms, and the effects in subgroups with high disease activity at recruitment were evaluated at week 52 using appropriate descriptive statistics, {\"I} ‡2 test and logistic regression. Results: At week 52, for belimumab 10 mg/kg, 17.0{\%} and 19.3{\%} of patients who achieved a Systemic Lupus Erythematosus Responder Index-4 also attained LLDAS in BLISS-52 and BLISS-76, respectively. Significantly more patients attained LLDAS on belimumab 10 mg/kg compared with placebo (12.5{\%} vs 5.8{\%}, OR 2.32, p=0.02 for BLISS-52; 14.4{\%} vs 7.8{\%}, OR 1.98, p=0.04 for BLISS-76). In a subgroup analysis, the difference in week 52 LLDAS attainment between belimumab 10 mg/kg and placebo was greater in patients who had higher disease activity at baseline, compared with the overall group. Conclusions: LLDAS was able to discriminate belimumab 10 mg/kg from placebo in the BLISS-52 and BLISS-76 trials. Our findings support the validity of LLDAS as an outcome measure in SLE clinical trials.",
keywords = "belimumab, LLDAS, lupus",
author = "Shereen Oon and Molla Huq and Vera Golder and Ong, {Pei Xuan} and Morand, {Eric F.} and Mandana Nikpour",
year = "2019",
month = "5",
day = "1",
doi = "10.1136/annrheumdis-2018-214427",
language = "English",
volume = "78",
pages = "29--633",
journal = "Annals of the Rheumatic Diseases",
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Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus. / Oon, Shereen; Huq, Molla; Golder, Vera; Ong, Pei Xuan; Morand, Eric F.; Nikpour, Mandana.

In: Annals of the Rheumatic Diseases, Vol. 78, No. 5, 01.05.2019, p. 29-633.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus

AU - Oon, Shereen

AU - Huq, Molla

AU - Golder, Vera

AU - Ong, Pei Xuan

AU - Morand, Eric F.

AU - Nikpour, Mandana

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Objective: We evaluated the discriminant capacity of the Lupus Low Disease Activity State (LLDAS) in post-hoc analysis of data from the BLISS-52 and BLISS-76 trials of belimumab in systemic lupus erythematosus (SLE). Methods: LLDAS attainment, discrimination between belimumab and placebo arms, and the effects in subgroups with high disease activity at recruitment were evaluated at week 52 using appropriate descriptive statistics, Ï ‡2 test and logistic regression. Results: At week 52, for belimumab 10 mg/kg, 17.0% and 19.3% of patients who achieved a Systemic Lupus Erythematosus Responder Index-4 also attained LLDAS in BLISS-52 and BLISS-76, respectively. Significantly more patients attained LLDAS on belimumab 10 mg/kg compared with placebo (12.5% vs 5.8%, OR 2.32, p=0.02 for BLISS-52; 14.4% vs 7.8%, OR 1.98, p=0.04 for BLISS-76). In a subgroup analysis, the difference in week 52 LLDAS attainment between belimumab 10 mg/kg and placebo was greater in patients who had higher disease activity at baseline, compared with the overall group. Conclusions: LLDAS was able to discriminate belimumab 10 mg/kg from placebo in the BLISS-52 and BLISS-76 trials. Our findings support the validity of LLDAS as an outcome measure in SLE clinical trials.

AB - Objective: We evaluated the discriminant capacity of the Lupus Low Disease Activity State (LLDAS) in post-hoc analysis of data from the BLISS-52 and BLISS-76 trials of belimumab in systemic lupus erythematosus (SLE). Methods: LLDAS attainment, discrimination between belimumab and placebo arms, and the effects in subgroups with high disease activity at recruitment were evaluated at week 52 using appropriate descriptive statistics, Ï ‡2 test and logistic regression. Results: At week 52, for belimumab 10 mg/kg, 17.0% and 19.3% of patients who achieved a Systemic Lupus Erythematosus Responder Index-4 also attained LLDAS in BLISS-52 and BLISS-76, respectively. Significantly more patients attained LLDAS on belimumab 10 mg/kg compared with placebo (12.5% vs 5.8%, OR 2.32, p=0.02 for BLISS-52; 14.4% vs 7.8%, OR 1.98, p=0.04 for BLISS-76). In a subgroup analysis, the difference in week 52 LLDAS attainment between belimumab 10 mg/kg and placebo was greater in patients who had higher disease activity at baseline, compared with the overall group. Conclusions: LLDAS was able to discriminate belimumab 10 mg/kg from placebo in the BLISS-52 and BLISS-76 trials. Our findings support the validity of LLDAS as an outcome measure in SLE clinical trials.

KW - belimumab

KW - LLDAS

KW - lupus

UR - http://www.scopus.com/inward/record.url?scp=85060567626&partnerID=8YFLogxK

U2 - 10.1136/annrheumdis-2018-214427

DO - 10.1136/annrheumdis-2018-214427

M3 - Article

VL - 78

SP - 29

EP - 633

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 5

ER -