Clinical SLE Disease Activity Index Score of Zero May be a More Pragmatic Outcome Measure in SLE Studies

Ioannis Parodis^1,2, Sharzad Emamikia^1,2, Iva Gunnarsson^1,2, Ronald F. van Vollenhoven^2,3 and Katerina Chatzidionysiou^1,4, ¹Rheumatology, Karolinska University Hospital, Stockholm, Sweden, Stockholm, Sweden, ²Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, ³Amsterdam Rheumatology and Immunology Center ARC, Department of Clinical Immunology & Rheumatology, University of Amsterdam, Amsterdam, The Netherlands, Amsterdam, Netherlands, ⁴Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: belimumab, Biologic agents, Outcome measures, systemic lupus erythematosus (SLE) and treatment

Session Information

Date: Monday, October 22, 2018

Title: Systemic Lupus Erythematosus – Clinical Poster II: Biomarkers and Outcomes

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Drug development in systemic lupus erythematosus (SLE) has been challenging. One of the reasons can be traced in the choice of outcome measures. In the clinical trials of belimumab, the primary endpoint was the SLE responder index (SRI) at week 52. In the present analysis, we investigated the frequency of the Lupus Low Disease Activity State (LLDAS) and a clinical SLE disease activity index 2000 (clinSLEDAI-2K) score of zero in relation to SRI.

Methods: A total of 1684 patients with SLE from the BLISS-52 (n=865) and BLISS-76 (n=819) trials were analysed. Data were accessed through a data sharing agreement with GSK. The clinician-based evaluation was defined as a Physician Global Assessment (PGA) score <0.5 in a 3-point scale, one of the conditions in the recently developed Definitions of Remission in SLE (DORIS), and was used for comparative purposes. For correlations, we used the Pearson correlation coefficient. For comparisons, we used the chi-square test.

Results: At week 52, the LLDAS definition was met in 8.6% of the patients (n=1332), and 34.5% had a clinSLEDAI-2K score of zero (n=1332). According to data from the initial studies, 45.1% were SRI responders at week 52 (n=1684). Among the three measures, clinSLEDAI-2K zero showed the strongest correlation with PGA <0.5 (r=0.36, P<0.001), whereas the correlations with SRI (r=0.25, P<0.001) and LLDAS (r=0.21, P<0.001) were more moderate. Comparing the placebo and 10 mg/kg belimumab treatment arms, SRI performed best at revealing the superiority of belimumab to placebo (P<0.001), followed by clinSLEDAI-2K zero (P=0.003), PGA <0.5 (P=0.004), and LLDAS (P=0.033) (Figure).

Conclusion: LLDAS appears to be a stringent outcome measure, being met by only 8.6% of the patients. A clinSLEDAI-2K score of zero showed the best correlation with the clinician-based evaluation. Since it is only based on one index (SLEDAI-2K), clinSLEDAI zero may be considered a more pragmatic outcome measure compared to SRI and LLDAS for use in SLE studies and clinical trials.

Disclosure: I. Parodis, None; S. Emamikia, None; I. Gunnarsson, None; R. F. van Vollenhoven, Amgen, Abbvie, BMS, Biotest, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex, 5; K. Chatzidionysiou, None.

To cite this abstract in AMA style:

Parodis I, Emamikia S, Gunnarsson I, van Vollenhoven RF, Chatzidionysiou K. Clinical SLE Disease Activity Index Score of Zero May be a More Pragmatic Outcome Measure in SLE Studies [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/clinical-sle-disease-activity-index-score-of-zero-may-be-a-more-pragmatic-outcome-measure-in-sle-studies/. Accessed .

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