Background/Purpose: The clinical effectiveness of 6-month IV BEL use in SLE has previously been described in a post hoc pooled analysis from six OBSErve cohort studies.¹ Here we present expanded post hoc analysis of eight pooled OBSErve studies investigating the long-term effectiveness of BEL on reducing oral CS (OCS) use and achieving low disease activity (LDA) and remission, which are important treatment targets for SLE to minimize irreversible organ damage.^2,3

Methods: This was a post hoc pooled analysis (GSK Study 219649) of data from eight OBSErve studies in Argentina, Canada, Germany, USA, Russia, Saudi Arabia, Spain, and Switzerland. Clinician-reported data were captured for adults with SLE at IV BEL initiation (index) and at 6–24 months after index. All studies captured 6 months of data after index, with Argentina and USA data extending up to 24 months after index. Enrollment was 6 months post index for all studies except Argentina and n=284/501 USA patients (pts) who enrolled 12 months after index. The primary objective was to describe the proportion of pts achieving a daily OCS dose ≤10 mg, ≤7.5 mg, ≤5 mg, or 0 mg at 6, 12, 18, or 24 months after index. Secondary objectives included: the proportion of pts who maintained their 6-month post index daily OCS dose threshold over time; and the proportion of pts achieving LDA (modified Lupus Low Disease Activity State; SLEDAI score ≤4 with no worsening of clinical manifestations and OCS dose ≤7.5 mg/day⁴) or remission (modified Definition Of Remission In SLE; SLEDAI score=0 and OCS dose ≤5 mg/day⁵) at 24 months after index.

Results: Data from 959 pts were included. Most pts were from the USA (52.2%), Germany (10.6%), and Argentina (8.4%). At enrollment, the mean age was 41.5 years, 89.5% were female, 64.6% were White (N=878 only); 55.2% had SLE for ≥5 years before enrollment.

At index, median (interquartile range) OCS dose was 10.0 (5.0, 20.0) mg/day; 14.5% were receiving an OCS dose of >20 mg/day and 41.0% >10 mg/day. The proportion of pts receiving OCS dose ≤7.5 mg/day increased from 38.5% at index to 69.4% at 6 months, 80.0% at 12 months, 83.7% at 18 months, and 92.1% at 24 months (data after 6 months for pooled Argentina/USA only; Figure 1A). A similar trend was seen among those who were receiving >10 mg/day at index (Figure 1B). Over 87% of pts maintained the same OCS low dose threshold at 12, 18, and 24 months as at 6 months after index (Figure 2). At index (N=447), 0.4% of pts were in LDA state and 0.2% in remission. At 24 months, 18.2% and 12.9% achieved LDA and remission, respectively (Table).

Conclusion: These data demonstrate a steroid-sparing effect of long-term BEL use, which was evident from 6 months and maintained over 24 months, as well as an improvement of disease activity indices in pts with SLE, further supporting the effectiveness of IV BEL in real-world SLE clinical management.

Funding: GSK References:

1 Collins CE et al. Rheumatol Ther 2020;7:949–65

2 Fanouriakis A et al. Ann Rheum Dis 2019;78:736–45

3 Golder V et al. Rheumatol 2020;59:(Suppl5)v19–v28

4 Franklyn K et al. Ann Rheum Dis 2016;75:1615–21

5 van Vollenhoven et al. Lupus Sci Med 2021;8:e000538

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-up-to-24-months-intravenous-iv-belimumab-bel-treatment-on-steroid-use-and-disease-activity-in-patients-with-sle-in-clinical-practice-additional-post-hoc-pooled-analysis-of-multicountry/