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2024-05-03T14:45:18.000Z

SLE-DAS as a disease activity measure: Post hoc analyses of phase II and III trials of anifrolumab

May 3, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in systemic lupus erythematosus.

Accurate and practical disease activity measures in the management of systemic lupus erythematosus (SLE) are limited.1 The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item tool that demonstrates high accuracy and sensitivity in assessing changes to disease activity.2

At the 14th European Lupus Meeting, Jesus presented post hoc analyses of phase II and III trials of anifrolumab to:

  • derive and validate the cut-off value for SLE-DAS for defining severe disease activity (SDA);1 and
  • evaluate if SLE-DAS enables easy identification of patients with SDA and moderate-to-severe disease activity (MSDA), and with worse health-related quality of life (HR-QoL). 1,2

Here, we summarize the key findings.

Methods1,2

  • These were post hoc analyses of aggregated intention-to-treat data from placebo arms in MUSE (NCT01438489), TULIP-1 (NCT02446912), and TULIP-2 (NCT02446899) trials on anifrolumab vs placebo in moderate-to-severe SLE.
  • British Isles Lupus Assessment Group (BILAG-2004) Index, SLE Disease Activity Index 2000 (SLEDAI-2K), and the patient-reported outcomes ([PROs]: lupus quality of life, EuroQoL-5D, Functional Assessment of Chronic Illness Therapy – Fatigue, and Patient Global Assessment) were assessed. The SLE-DAS was retrospectively scored at each visit.
  • The Mann-Whitney test was used to compare PROs between patients in SDA vs non-SDA and MSDA vs non-MSDA at Week 12 and Cohen’s d was used to compare the magnitude of these differences.

Key findings

SDA1,2

  • A total of 438 patients with SLE were included.
  • At Week 12, 46.6% in the derivation cohort and 42.4% in the validation cohort were in SDA by BILAG-2004.
  • SLE-DAS >9.90 (area under curve = 0.847) was the best cut-off to identify patients in SDA in the derivation cohort, which showed 77.8% sensitivity and 79.6% specificity in the validation cohort.
  • Patients in SDA by SLE-DAS reported significantly worse impact in all HR-QoL PROs (Figure 1).

MSDA2

  • Of 438 patients identified as MSDA by BILAG-2004, 96.1% were classified as MSDA by SLE-DAS, and 92.9% by SLEDAI-2K.
  • At Week 12, SLE-DAS and SLEDAI-2K presented significantly worse impact in all HR-QoL PROs (Figure 1).

Figure 1. HRQoL comparison between patients in A SDA vs non-SDA1 and B MSDA vs non-MSDA2, according to SLE-DAS, BILAG-2004, and SLEDAI-2K*

BILAG, British Isles Lupus Assessment Group; EQ-5D, EuroQoL-5D; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; MSDA, Moderate-to-Severe Disease Activity; PtGA, Patient Global Assessment; QoL, quality of life; SDA, Severe Disease Activity; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; VAS, visual analog scale.
*Data from Jesus, et al.1,2

 

Key learnings

  • SLE-DAS SDA and MSDA may be superior in identifying patients with worse HR-QoL, as compared with BILAG-2004 and SLEDAI-2K, thereby facilitating good physician-patient concordance.
  • SLE-DAS could help identify patients with MSDA for SLE clinical trials and those who may require biologic therapy in clinical settings.

  1. Jesus D, Henriques C, Matos A, et al. The SLE-DAS enables easy identification of SLE patients with severe disease activity and worse health-related quality of life: derivation and validation in post-hoc study of anifrolumab phase 2 and 3 clinical trials. Abstract #P67. 14th European Lupus Meeting; March 21, 2024; Bruges, BE.
  2. Jesus D, Matos A, Henriques C, et al. The SLE-DAS enables easy identification of SLE patients with moderate-to-severe disease activity and worse HR-QoL in the screening for SLE clinical trials: a post-hoc study in the phase 2 and 3 anifrolumab trials. Abstract #P127. 14th European Lupus Meeting; March 21, 2024; Bruges, BE.

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