Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies. (1st February 2019)

• Record Type: Journal Article
• Authors: Parodis, Ioannis; Emamikia, Sharzad; Gomez, Alvaro; Gunnarsson, Iva; van Vollenhoven, Ronald F.; Chatzidionysiou, Katerina
• Is Part Of: Expert opinion on biological therapy. Volume 19:Number 2(2019)
• Page Start: 157
• Page End: 168
• Publication Date: 2019-02-01
• Subjects: Systemic lupus erythematosus -- treatment -- outcome measures -- biologics -- belimumab; Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1080/14712598.2019.1561856
• Languages: English
• ISSNs: 1471-2598

Abstract

ABSTRACT: Objectives : Development of therapies for systemic lupus erythematosus (SLE) has in part been limited by the lack of suitable outcome measures in clinical trials. 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). Methods : A total of 1684 SLE patients from the BLISS-52 (n = 865) and BLISS-76 (n = 819) trials were surveyed. Physician's Global Assessment (PGA) scores <0.5 (3-point scale) were used for comparisons. We used the chi-square test for comparisons and the phi coefficient for correlations. Results : At week 52, LLDAS was achieved by 8.6% of patients, cSLEDAI-2K = 0 by 34.5% and SRI-4 by 45.1%. cSLEDAI-2K = 0 showed the strongest correlation with PGA <0.5 (rφ = 0.36, P < 0.001). cSLEDAI-2K = 0 unveiled the superiority of belimumab 10 mg/kg over placebo ( P = 0.003) with a magnitude which was comparable to that of SRI-4 ( P < 0.001). LLDAS displayed a more moderate separation ( P = 0.033). Conclusions : LLDAS was a stringent measure. cSLEDAI-2K = 0 showed the strongest correlation with the clinician-based evaluation. Being based on the SLEDAI-2K only, cSLEDAI-2K = 0 may be considered a more pragmatic outcome measure in SLE studies compared with composite tools. Trial registration: ClinicalTrials.gov identifier: NCT00424476. Trial registration: ClinicalTrials.gov identifier: NCT00410384.