‘Very important’: Belimumab decreases lupus flare vs placebo in early, established disease
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Treatment with belimumab resulted in fewer flares in patients with either early or established systemic lupus erythematosus, especially among those with no baseline organ damage, according to data presented at the EULAR 2024 Congress.
“The benefits of early treatment of SLE for the prevention of repeated flares of disease activity, as well as the need to limit glucocorticoid exposure, are increasingly recognized,” study co-author Karen Costenbader, MD, MPH, professor of medicine at Harvard Medical School and lupus program director at Brigham and Women’s Hospital, told Healio. “The 2023 EULAR guidelines for the treatment of SLE recommend earlier use of biologics at the same time as other immunosuppressants are considered.
“Thus, we examined data from the pooled analyses of belimumab from all registrational clinical trials to investigate flare rates and prevention of flares among those treated earlier vs. later in their disease course,” she added.
To examine SLE flares in patients with either early or established disease who have received belimumab (Benlysta, GlaxoSmithKline), alongside standard therapy, Costenbader and colleagues conducted a post hoc analysis that pooled data from five international phase 3 trials. The included trials were BLISS-76, BLISS-52, North East Asia, EMBRACE and BLISS-SC. Adults with SLE were randomly assigned to receive either belimumab (n = 1,869) or placebo (n = 1,217). Both groups additionally received standard therapy.
The researchers assessed time to lupus flare across 52 weeks in subgroups of early vs. established disease. Meanwhile, lupus flares were assessed based on definitions from the Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index flare index (SFI) and the British Isles Lupus Assessment Group (BILAG).
Over 52 weeks, a significantly fewer number of patients treated with belimumab demonstrated a severe SFI flare (HR = 0.61; 95% CI, 0.51-0.72), any SFI flare (HR = 0.83; 95% CI, 0.76-0.91) or any BILAG flare (HR = 0.72; 95% CI, 0.62-0.83) vs. placebo, according to the researchers.
Patients treated with belimumab also had fewer flares in both subgroups of early and established disease. Patients with early disease demonstrated fewer flares whether treated with belimumab or placebo.
“This post hoc analysis showed fewer patients experienced flares with belimumab versus placebo in the pooled population and in early or established disease subgroups, with particular benefit suggested in patients with no baseline organ damage,” Costenbader said. “The proportion of patients with flares was lower in those with early versus established disease, for belimumab and placebo.
“This is very important information for clinicians as preventing flares is a central goal of treating lupus,” she added. “Every time there is a flare, more organ damage occurs, as does more exposure to glucocorticoids. These results were not included in the original trial reports.”
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Mosca M. POS0530. Presented at: EULAR 2024 Congress; June 12 to June 15, 2024, Vienna, Austria.
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