TOPLINE

In patients with systemic lupus erythematosus (SLE) who achieved prolonged remission with belimumab, a gradual dose-spacing protocol allowed some to reduce or discontinue therapy without disease flares. 

METHODOLOGY

• Researchers conducted a retrospective study to assess the feasibility and safety of spacing and withdrawing belimumab in patients with long-standing SLE remission.
• They identified 152 adults with SLE treated with belimumab across four centers in Italy between January 2013 and December 2025. Patients eligible for spacing protocol had received belimumab for at least 2 years and had remained flare-free for more than 6 months.
• Belimumab was tapered by stepwise extension of the dosing interval from 200 mg subcutaneously every 10 days to every 28 days or from 10 mg/kg intravenously every 6 weeks to every 16 weeks before complete withdrawal.
• The primary endpoint was the occurrence of SLE flares, defined as new or worsening clinical signs or symptoms of active SLE associated with increased disease activity, measured using SLE Disease Activity Index 2000 (SLEDAI-2K) score > 4 plus ≥ 1 British Isles Lupus Assessment Group A or B item, and required escalation of immunosuppressive therapy. The follow-up duration was 21 months.
• Secondary endpoints included death and progression of damage accrual.

TAKEAWAY

• A total of 22 patients (mean age, 47 years; 95.5% women) underwent belimumab dose spacing. No SLE flares occurred among these patients during follow-up, and no patient required glucocorticoid dose escalation or a return to a previous belimumab dosing interval.
• A longer duration of SLE remission (odds ratio [OR], 1.02; P = .006) and a lower SLEDAI-2K score (OR, 0.62; P = .018) predicted allocation to belimumab spacing.
• A total of seven patients successfully discontinued belimumab. No deaths or progression of damage accrual occurred.
• Patients advanced stepwise to less frequent belimumab dosing, and daily glucocorticoid doses decreased over time (P < .001 for both).

IN PRACTICE

“We believe that a personalized approach is essential in SLE as treatment decisions during remission should be made carefully weighing the relapse risk against that of continuing immunosuppression,” the authors wrote.

SOURCE

This study was led by Alice Bartoletti, MD, ASST Gaetano Pini, Milan, Italy. It was published online on July 9, 2026, as a short report in Lupus Science & Medicine.

LIMITATIONS

A small number of patients underwent belimumab spacing. The study was retrospective. Researchers enrolled only those patients who were in a quiescent state of disease and lacked a control group.

DISCLOSURES

The authors did not report any specific source of funding. Four authors reported receiving consultancy and/or speaker fees from pharmaceutical and healthcare companies such as GSK, AstraZeneca, and Novartis.

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