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Abstract
Background The SLE-DAS is a recently validated 17-item instrument with high accuracy and sensitivity to changes in disease activity, that provides a validated and easy to assess definition for moderate-to-severe disease activity (MSDA).
Objectives To assess the ability of the SLE-DAS to identify patients with MSDA to participate in SLE clinical trials and to evaluate if patients with MSDA by SLE-DAS, SLEDAI-2K and BILAG-2004 present worse health-related quality of life (HR-QoL).
Methods Post-hoc analysis of aggregated intention-to-treat data from the placebo arms from MUSE, TULIP-1 and -2 trials (NCT01438489, NCT02446912 and NCT02446899) of anifrolumab versus placebo for moderate-to-severe SLE. We analyzed the BILAG-2004, SLEDAI-2K and patient reported outcomes (PROs) [FACIT-F, LupusQoL, EQ-5D and Patient Global Assessment (PtGA)]. The SLE-DAS was retrospectively scored at each visit. At the screening visit, we assessed the ability of SLE-DAS (>7.64) and SLEDAI-2K (>6) MSDA categories to identify patients in MSDA by BILAG-2004 (numerical score >7). We further compared the PROs between patients in MSDA vs non-MSDA by SLE-DAS, SLEDAI-2K and BILAG-2004, at week 12, using Mann-Whitney test. The magnitude of these differences was compared using Cohen’s d.
Results We assessed 438 SLE patients in MSDA by BILAG-2004, at the screening visit. The SLE-DAS and the SLEDAI-2K identified 96.1% (95%CI 94.3%-97.9%) and 92.9% (95%CI 90.5%-95.3%) of these patients, respectively. At week 12, patients in MSDA by SLE-DAS and SLEDAI-2K presented significantly severe impact in all HR-QoL PROs, and patients in MSDA by BILAG-2004 in 4/8 domains of LupusQoL, EQ-5D, FACIT-F and PtGA (table 1). Importantly, the SLE-DAS MSDA presented numerically higher effect sizes in the majority aspects of HR-QoL PROs, as compared to BILAG-2004 and SLEDAI-2K.
Conclusion The SLE-DAS enables easy identification of patients in MSDA to participate in SLE clinical trials and may guide the physicians to identify patients requiring biologic therapy in clinical practice. The SLE-DAS moderate-to-severe disease activity identifies patients with worse aspects of HR-QoL, thus enabling good agreement between physicians’ and patients’ perspectives. This study suggests that SLE-DAS MSDA may present superior ability to discern patients with worse aspects of HR-QoL as compared to BILAG-2004 and SLEDAI-2K.
Acknowledgement This publication is based on research using data from data contributors AstraZeneca that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication.
Health-related quality of life comparison between patients in moderate-to-severe disease activity (MSDA) vs non-MSDA according to SLE-DAS (>7.64), BILAG-2004 (numerical score >7) and SLEDAI-2K (>6)
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