‘Earlier use of biologics’ like belimumab may improve long-term lupus outcomes
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Early use of biologics like belimumab may limit complications associated with steroid use and improve long-term outcomes in systemic lupus erythematosus, according to data presented at the EULAR 2024 Congress.
“Often clinicians reserve the use of the anti-BLyS biologic belimumab for the treatment of SLE until multiple other lines of therapy have been tried and not worked for patients, at which time substantial and irreversible organ damage may have been done,” Karen Costenbader, MD, MPH, professor of medicine at Harvard Medical School and lupus program director at Brigham and Women’s Hospital, in Boston, told Healio.
“The benefits of early treatment of SLE, as well as the need to limit glucocorticoid exposure, are increasingly recognized,” she added. “In addition, the 2023 EULAR guidelines for the treatment of SLE recommend earlier use of biologics at the same time as other immunosuppressants are considered.”
To assess the impact of belimumab (Benlysta, GlaxoSmithKline) vs. placebo alongside standard therapy in patients with SLE, across early and established disease subgroups, Costenbader and colleagues conducted a post hoc analysis of data from five trials of the drug published over the last decade. Systemic lupus erythematosus Responder Index 4 (SRI-4) response at 52 weeks was the primary outcome of interest.
The analysis included 3,086 patients overall, with 1,869 in the treatment group and 1,217 in the placebo group. Early disease was defined as a duration of less than 2 years, while established disease was characterized as 2 years or more.
According to the researchers, significantly more patients treated with belimumab than placebo achieved SRI-4 response at 52 weeks (OR = 1.7; P < .0001). This result was observed regardless of baseline SLE disease duration, the researchers wrote. Belimumab bested placebo in terms of SRI-4 response among patients treated for less than 2 years (OR = 1.38; P = .0219), and in those treated for 2 years or greater (OR = 1.85; P < .0001).
Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) score at baseline also failed to impact response, with belimumab superior to placebo in patients with an SDI score of 0 (OR = 1.56; 95% CI, 1.29-1.89), as well as those with a score of 1 or greater (OR = 1.95; 95% CI, 1.5-2.54]; both P < .0001). Similarly, belimumab improved over placebo in terms of SRI-4 response among patients using immunosuppressants at baseline (OR = 1.77; 95% CI, 1.43-2.18), and those who did not use immunosuppressants at baseline (OR = 1.63; 95% CI, 1.31-2.03).
“The observed proportion of SRI-4 responders was slightly higher in all three early disease subgroups for both belimumab — 57% to 58% — and placebo — 45% to 48% — compared with the overall pooled population — 55% of belimumab and 42% for placebo, 42% — and the established disease subgroups — 51% to 54% for belimumab, and 35% to 39% for placebo,” Costenbader said.
“Although this is a post hoc analysis, and the original belimumab trials were not intentionally designed to compare these groups, these results do support use of belimumab in early disease to improve outcomes,” she added. “Longer, prospective studies in a population of patients with early SLE would be needed to confirm these findings.”
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Costenbader K. POS0544. Presented at: EULAR 2024 Congress; June 12 to June 15, 2024, Vienna, Austria.
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