Evaluating the Use of Glucocorticoids Among Belimumab‐Treated Patients With Systemic Lupus Erythematosus in Real‐World Settings Using the Rheumatology Informatics System for Effectiveness Registry

Abstract

Objective Glucocorticoids are part of standard therapy for systemic lupus erythematosus (SLE), despite adverse effects associated with long‐term treatment. Belimumab improved clinical manifestations of SLE and reduced glucocorticoid doses in clinical trials and clinical practice; however, associations have not been examined using multi‐institutional electronic health record (EHR) data. Using the Rheumatology Informatics System for Effectiveness registry, we examined glucocorticoid use patterns among belimumab‐treated adults with SLE. Methods This retrospective analysis (GSK Study 209267) used EHR prescription records of patients with SLE managed by rheumatologists. Eligible patients had an index date (first belimumab prescription) between January 2014 and June 2018. The primary analysis compared patients' mean daily oral glucocorticoid (prednisone equivalent) dose over the 6 months preindex versus 6 months post index. An exploratory analysis assessed glucocorticoid doses at 12 and 24 months post index for patients with extended follow‐up. Results Of the 1987 patients receiving their first belimumab prescription, 767 had available glucocorticoid prescribing data, whereas 204 (primary analysis population) had glucocorticoids prescribed in the 6 months preindex and received belimumab according to the prescribing information for the first 8 weeks post index. The mean (SD) glucocorticoid dose was 12.5 (13.5) mg/day 3 months preindex, reducing to 10.3 (10.6) mg/day over the 6 months post index, and 8.7 (9.4) and 9.0 (9.3) mg/day at 12 and 24 months post index. Conclusion This study showed reductions in mean daily glucocorticoid dose after belimumab initiation. Several limitations of EHRs for real‐world effectiveness research were identified, which limited interpretation of results and may inform future study designs.

Real-world use and outcomes of belimumab in childhood-onset lupus: A single-center retrospective study

“…This is consistent with reports in adults using claims data and the Rheumatology Informatics System for Effectiveness (RISE) Registry, demonstrating steroid-sparing effects among SLE patients who persisted on belimumab therapy. [5][6][7] Unlike prior adult series, which showed improvements in disease activity and reduced flares after starting belimumab, 6,12,13 we did not detect a statistically significant decrease in SLEDAI-2K scores at 6 and 12 months, although scores were numerically reduced from baseline. It is possible that no difference existed in our cohort, or that our study was underpowered to detect small improvements due to the limited sample size of our retrospective cohort.…”

“…The patients in our cohort were all on combination therapy, and most had been on multiple immunomodulatory treatments prior to starting belimumab, indicating that belimumab was used primarily for disease that was refractory to conventional immunomodulators. This contrasts with adult studies of belimumab real-world effectiveness, in which the use of co-administered glucocorticoids, antimalarials, and immunosuppressants was less common, 5–7 perhaps indicating more mild disease in adults, and/or the use of belimumab earlier in the disease course. Although belimumab is now approved for lupus nephritis in both adults and children, use in patients with active nephritis was uncommon in our cohort, and therefore we were unable to assess belimumab’s impact on renal outcomes.…”

“…The year of belimumab initiation ranged from 2013 to 2020. The median [IQR] SLEDAI-2K score at the time of belimumab initiation was 9 [6][7][8][9][10][11]. While more than half of patients in our cohort had a history of lupus nephritis, most commonly class IV, only one patient had active nephritis when belimumab was initiated.…”

“…Belimumab, a B-cell-directed biologic medication targeting B-lymphocyte stimulator (BLyS), is the only therapy approved for systemic lupus erythematosus (SLE) in children. While clinical trials in both adult 1,2 and pediatric populations 3,4 and adult studies of real-world effectiveness [5][6][7] have shown improved disease control and decreased oral glucocorticoid use after initiating belimumab, effectiveness has not been wellstudied in children outside of the trial setting. 8 National disease registries of children with childhood-onset lupus (cSLE) show that belimumab use has been uncommon, 9,10 and there are no guidelines for its use in children.…”

Remission and clinical patterns of systemic lupus erythematosus (SLE) in Pakistan: a retrospective cohort study

“…Belimumab, anifrolumab and tofacitinib were not available in Pakistan during the period of this study. Their addition along with newer SLE drugs in the clinical pipeline will likely enhance the possibility of early and prolonged clinical remission and minimization of steroid use (42, 43).…”