Background/Purpose: To assess the efficacy of belimumab in patients with SLE who had high disease activity at baseline, as defined by SELENA-SLEDAI score ≥10. 

Methods: In 2 randomized, double-blind, multicenter phase 3 studies, 1684 SLE patients with SELENA-SLEDAI ≥6 at baseline were treated with placebo, or belimumab 1 or 10 mg/kg, plus standard SLE therapy (NCT00071487/NCT00583362). In a post-hoc analysis, the SLE Responder Index (SRI) at wk 52, flares, corticosteroid use, fatigue, and the SF-36 vitality domain were examined in a subgroup of patients with baseline SELENA-SLEDAI ≥10.

Results: 877 patients (52%) had SELENA-SLEDAI scores ≥10 on entry to the BLISS trials: 299, 283, and 296 were randomized to placebo, and belimumab 1 and 10 mg/kg, respectively. Mean baseline characteristics were similar across treatment groups. In patients with SELENA-SLEDAI ≥10 vs ≤9, >80% vs 56% were anti-double-stranded−DNA positive and 55%/67% vs 34%/55% had low C3/C4 levels. In patients with SELENA-SLEDAI ≥10 vs all patients in the BLISS trials, 89% vs 57% had >3 organ systems involved. Belimumab 1 and 10 mg/kg significantly improved SRI response, and reduced prednisone use in high disease activity patients at wk 52 (see table). Treatment with belimumab 10 mg/kg generally resulted in a greater response than with 1 mg/kg and placebo regarding reduction in severe flare risk, and improvements in SRI response, fatigue, and SF-36 vitality at wk 52.

Conclusion: Belimumab 10 mg/kg significantly reduced disease activity, flares, corticosteroid use, and fatigue in SLE patients with high disease activity, as defined by baseline SELENA-SLEDAI scores ≥10.

 

Efficacy in Patients With SELENA-SLEDAI Scores ≥10 at Baseline
Response parametera	Placebo (n = 299)	Belimumab
		1 mg/kg (n = 283)	10 mg/kg (n = 296)
SRI response: wk 52, %   p value	44.1	58.0 <0.001	63.2 <0.001
No new BILAG A and ≤1 new B score        p value	65.4	73.5 0.024	74.3 0.017
≥4-point reduction in SELENA-SLEDAI        p value	48.0	60.4 0.001	66.2 <0.001
No worsening in PGA        p value	63.1	73.1 0.006	74.0 0.004
Patients with ≥1 severe flare, %      Severe flare risk over 52 wk: HR            (95% CI)b        p value	28.8	21.6 0.73 (0.52−1.01) 0.054	18.2 0.59 (0.42−0.83) 0.003
Prednisone reduction ≥25% from baseline to     ≤7.5mg/day: wk 40−52, n (%)c   p value	12/181 (6.6)	32/182(17.6) 0.002	31/186(16.7) 0.004
% patients with reduction in baseline prednisone from > 7.5 to ≤7.5 mg/d at week 52   p value	16/181 (8.8)	35/182(19.2) 0.007	41/186 (22.0) <0.001
Mean FACIT-Fatigue score improvement: wk 52    p value	3.38	4.76 0.103	5.12 0.024
Mean SF-36 vitality score change   p value	7.82	9.69 0.196	10.76 0.044
ap values represent comparisons of belimumab treatment with placebo; bCox proportional hazards model; cincludes only patients with baseline prednisone >7.5 mg/d. BILAG, British Isles Lupus Assessment Group; FACIT, Functional Assessment of Chronic Illness Therapy; PGA, Physician’s Global Assessment.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-belimumab-in-systemic-lupus-erythematosus-patients-with-high-baseline-disease-activity/