期刊
EXPERT OPINION ON BIOLOGICAL THERAPY
卷 19, 期 2, 页码 157-168出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/14712598.2019.1561856
关键词
Systemic lupus erythematosus; treatment; outcome measures; biologics; belimumab
资金
- Swedish Research Council
- Professor Nanna Svartz Foundation [2017-00213]
- Swedish Rheumatism Association
- King Gustaf V's 80-year Foundation
- Ingegerd Johansson's Fund
- Stockholm County Council
- Karolinska Institutet Foundations
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 (r=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.
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