Fanouriakis A, et al. - This trial incorporated an analysis of the ability of belimumab to achieve low disease activity states in patients with systemic lupus erythematosus (SLE). In over 40% of unselected patients, belimumab exhibited efficacy in achieving low disease activity, in combination with the reduction of corticosteroid dosage and the number of flares. Response to the drug was found among both serologically active and inactive patients.

Methods

• The scheme of this research was a multicentre prospective observational study.
• The eligible candidates included consecutive SLE patients receiving belimumab for at least 3 months, due to active disease refractory to at least one conventional immunosuppressant.
• Researchers documented the disease activity, including the recently defined lupus low disease activity state (LLDAS) and remission (SLEDAI-2K=0), accrual of organ damage, flares and side effects.

Results

• A total of 91 subjects were enrolled [94.5% women, mean (SD) age 45.9 (12.5) years].
• Arthritis (76.7%), rash (72.5%), serologic activity (low C3/C4 and/or high anti-dsDNA; 54.9%), hair loss (47.2%) and mucosal ulcers (27.5%) served as the most frequent manifestations.
• Median (range) duration of treatment was 10.5 (3.0-42.1) months.
• A substantial decrease was achieved via belimumab in the average SLEDAI-2K, physician global assessment (PGA) and daily prednisone dose over time, as early as 3 months after initiation, with over 20% of patients discontinuing corticosteroids.
• Despite a more pronounced reduction in clinical (ie excluding serology) SLEDAI-2K among candidates who were serologically active (from 8 to 1.5 at 12 months) than serologically inactive (from 6 to 4) at baseline, no variation was discovered in the attainment of LLDAS between the two groups.
• It was reached by more than 40% of completer participants after 9-12 months.
• Findings also unveiled a reduction in the number of flares and severe flares by 62% and 50%, respectively, during the first 12 months of treatment.
• Discontinuation of treatment was reported in 20 patients (22.0%), which was attributed to inadequate response and 2 as a result of side effects potentially related to the drug.