TOPLINE:

Patients with systemic lupus erythematosus (SLE) who received belimumab monotherapy had remission rates, Lupus Low Disease Activity State (LLDAS) attainment, and flare rates comparable to those who received a combination therapy of belimumab plus immunosuppressants over 12 months.

METHODOLOGY:

• Researchers conducted a retrospective study using data from the Spanish Belimumab Registry to compare the effectiveness of belimumab alone vs belimumab in combination with immunosuppressants in adult patients with SLE.
• They included 258 patients with SLE (mean age, 41.9 years; 91.5% women) who had received belimumab for at least 12 months: 177 patients received belimumab plus immunosuppressants, and 81 patients received belimumab alone.
• The primary outcome was remission at 12 months, defined by the 2021 Definition of Remission in SLE (DORIS) criteria.
• The secondary outcomes were achievement of the LLDAS, physician-assessed response, glucocorticoid use, flare rates, and organ damage progression, all evaluated at baseline, 6 months, and 12 months.
• Overlap propensity score weighting was applied for a balanced comparison between treatment groups. 

TAKEAWAY:

• Patients on belimumab with immunosuppressants had a higher prevalence of hematologic (74.6% vs 54.3%; P = .001) and renal (39.0% vs 24.7%; P = .025) involvement and cutaneous manifestations including rash (62.1% vs 43.2%; P = .004) and oral/nasal ulcers (46.0% vs 30.9%; P = .020) than those on belimumab monotherapy.
• At 12 months, DORIS remission was achieved by 48.1% of patients who received belimumab with immunosuppressants and 51.4% of those who received belimumab monotherapy, with no statistically significant difference between the groups.
• Both the belimumab monotherapy and combination therapy groups had comparable reductions in SLE Disease Activity Index scores, with comparable rates and severity of flares. No significant between-group difference was noted in the proportion of patients who achieved LLDAS at 12 months.
• After adjustment with overlap propensity score weighting, remission rates at both 6 and 12 months were not significantly different between the treatment groups.

IN PRACTICE:

"These results may aid in identifying patient subgroups for whom BEL [belimumab] monotherapy represents a reasonable therapeutic option in clinical practice, at least in non-renal SLE. Tailoring treatment according to disease phenotype may help minimize unnecessary IS [immunosuppressant] exposure and its associated risks, including adverse effects and long-term organ damage," the authors wrote. 

SOURCE:

The study was led by Beatriz Frade-Sosa, Rheumatology Department, Hospital Clinic de Barcelona, Barcelona, Spain. It was published online on February 06, 2026, in Rheumatology.

LIMITATIONS:

Baseline differences in organ involvement, such as higher rates of renal and hematologic manifestations in those who received combination therapy, may have reflected selection bias that the adjusted model could not fully capture. Residual confounding could not be excluded. Flare recurrence was not monitored over a longer follow-up period.

DISCLOSURES:

The study did not receive any specific funding. Some authors reported receiving grants, speaker honoraria, consulting fees, and payments for educational talks or presentations and having other ties with various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.