Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA

Abstract

ObjectiveTo examine disease activity and clinical outcomes, and describe overall patterns of systemic lupus erythematosus (SLE) care in patients who received belimumab in a real-world clinical setting.MethodsThis observational cohort study was conducted in US clinical practices. Rheumatologists (n=92) identified adults with SLE who had received ≥8 infusions of belimumab plus standard of care (SoC). Physicians assessed disease outcomes at 6-month intervals using patient medical charts, for up to 24 months. The primary outcome was physician-assessed change in SLE disease. Other outcomes included change in steroid use, laboratory tests and healthcare resource utilisation (HCRU).ResultsOf 501 patients (intent-to-treat population (ITT)), 446 were female, mean age was 43.3 years and 98% had moderate/severe disease activity at baseline (first dose of belimumab). Data for 277 patients who completed 24 months of belimumab treatment were available. Among the ITT, a ≥50% improvement in overall clinical response between baseline and month 6 was reported for 48.7% of patients; continued improvement was seen at all subsequent 6-month intervals relative to the previous timepoint. The percentage of patients with moderate/severe disease also decreased at each timepoint. At baseline, 77.0% of patients received steroids at a mean (SD) prednisone equivalent dose of 19.9 (14.39) mg/day, which decreased to 8.4 (7.35) mg/day at month 6 and 6.1 (9.31) mg/day at month 24. Abnormal laboratory values typically associated with SLE also demonstrated improvements at month 6, which continued through 24 months. HCRU decreased over the duration of the study.ConclusionsPatients with SLE who received belimumab plus SoC for up to 24 months demonstrated improvements in disease severity and laboratory values and a reduction in steroid use and HCRU as early as month 6. Improvements continued through 24 months, providing evidence of reduced disease activity among patients taking belimumab in real-world clinical practice.

Belimumab in systemic lupus erythematosus: a perspective review

“…Data on 195 patients show response to belimumab at 3 and 6 months post-initation to be consistent with those reported in the phase III trials, with 48% of patients responding clinically by 3 months and 58% of patients by 6 months [Hui-Yuen et al 2014]. A similar observational study of 384 SLE patients over 12 months revealed sustained efficacy of belimumab after 12 months of use and allowed for tapering of corticosteroid dose [Collins et al 2013]. However, six patients were also started on corticosteroids during the study.…”

The Future of B-cell Activating Factor Antagonists in the Treatment of Systemic Lupus Erythematosus

“…Since its approval by the FDA, "real-world" clinical experience with belimumab has largely been positive [61][62][63]. Also since approval of belimumab as an IV drug, a randomized, double-blind, placebo-controlled trial of belimumab (200 mg fixed dose SC weekly through week 52) plus SOC in SLE demonstrated a statistically significantly greater response rate among belimumab-treated subjects than among placebo-treated subjects [64].…”

When to use belimumab in SLE

“…Importantly, as a reduction in SLE flares was extensively reported [2][3][4][5][6][7][8], it looks advisable to prompt belimumab especially in patients displaying a relapsing-remitting disease pattern, in whom a significant decrease in flare rate is among the fundamental treatment goals.…”

“…Importantly, relevant real-life experience [4,6,7,9] as well as a 7-year long-term extension study involving patients coming from the phase 2 RCT who had had an improvement in physician global assessment (PGA) since baseline proved a long-standing disease control and decrease in flare rate during the overall 7-year observation on belimumab treatment [17], suggesting such positive effects are long-lasting. Notably, published studies including RCT, long-term extensions studies and real-life experience underlined a good safety and tolerability profile of belimumub use even when added to immunosuppressive therapy.…”

“…Several case series and case reports and subsequently a large multicenter observational study have been carried out after BLISS trials [2][3][4][5][6][7][8][9][10] (Table 1), all converging on belimumab being able to improve control of disease activity and reduce daily corticosteroid intake, which are indeed expected to reduce organ damage in the long term. Unfortunately, those studies did not systematically measure disease activity according to approved scores, as retrospective observations were performed that were influenced by clinical practice.…”