Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina

Abstract

Objective: To describe clinical effectiveness of belimumab for systemic lupus erythematosus (SLE) in real-world practice in Argentina.

Methods: This retrospective, observational study analysed medical record data of patients with SLE treated with belimumab in 15 centres in Argentina. Primary endpoint: overall clinical response (assessed on a scale similar to the 6-point Physician Global Assessment) at months 6, 12, 18 and 24, all versus index (belimumab initiation). Secondary endpoints: improvement in disease activity (SELENA-SLEDAI), SLE manifestations, and corticosteroid dose change.

Results: Records for 81 patients (91% female) were analysed. Clinical improvements were reported for 95%, 95%, 98% and 100% patients at 6, 12, 18, and 24 months post index, respectively. Mean SELENA-SLEDAI score decreased from 11.21 at index to 4.76, 3.77, 3.86 and 2.17 at 6, 12, 18, and 24 months post index, respectively. Number of flares decreased from 1.05 at index to 0.21, 0.09, 0.22 and 0.30 at 6, 12, 18, and 24 months post index, respectively. Mean corticosteroid dose was 14.59 mg/day at index, and 6.45, 5.18, 5.17 and 4.78 mg/day at 6, 12, 18, and 24 months post index, respectively.

Conclusions: Real-world patients with SLE treated with belimumab in Argentina demonstrated clinical improvements and reductions in corticosteroid dose.

Keywords: Belimumab; disease activity; observational study; real-world; steroid sparing; systemic lupus erythematosus.

Figure 1.

Study design.

Figure 2.

Patient disposition and withdrawals. *Patients did not receive belimumab long enough to be included in the next follow-up period/physicians withdrew from the next follow-up period (n = 2, 7–12 months; n = 23, 13–18 months; n = 10, 19–24 months)

Figure 3.

Clinical outcomes in patients with SLE after 6, 12, 18 and 24 months of belimumab therapy. (a) Physician evaluation of overall clinical response, (b) mean number and severity of flares, (c) mean SELENA-SLEDAI score. P-value represents change versus index; *p < 0.001; **p = 0.001. SELENA-SLEDAI: Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index; SD: standard deviation; SLE: systemic lupus erythematosus.

Figure 4.

Change in mean dose of corticosteroids (a) and antimalarials and azathioprine (b) over the study period. P-value represents change versus index; *p < 0.001; **p = 0.01. SD: standard deviation.