Real-World Effectiveness of Belimumab in the Treatment of Systemic Lupus Erythematosus: Pooled Analysis of Multi-Country Data from the OBSErve Studies

Collins, Christopher; Cortés-Hernández, Josefina; García, Mercedes; Kempis, Johannes von; Schwarting, Andreas; Touma, Zahi; Kurtinecz, Milena; Gairy, Kerry

doi:10.1007/s40744-020-00243-2

Cited by 39 publications

(30 citation statements)

References 21 publications

(54 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Among the 80% of patients who were taking oral glucocorticoids at enrolment, 78% were able to reduce or discontinue steroid use after 6 months of belimumab treatment, and of those who were still using steroids, >50% achieved doses �7.5 mg/day. 82 Ethnicity did not appear to affect magnitude of improvement in clinical response, transitions toward milder disease or patterns of steroid use, with similar levels of improvement observed among white and Black African ancestry patients up to 24 months of follow-up. 77 In the subgroup of patients of Black African ancestry in OBSErve US who continued to receive belimumab over 24 months (n ¼ 69/123), substantial reductions in disease activity and severity, and oral corticosteroid use were observed.…”

Section: Belimumab and Patient Reported Outcomesmentioning

confidence: 59%

10 Years of belimumab experience: What have we learnt?

Levy

Gonzalez‐Rivera

Khamashta

et al. 2021

Lupus

Self Cite

View full text Add to dashboard Cite

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease affecting both adults and children. Belimumab is the only biologic approved for SLE, and the first in a class of drugs known as B-lymphocyte stimulator-specific inhibitors. The introduction of intravenous belimumab in 2011 was a major advance, being the first new therapy approved for SLE in over 50 years. As of April 2021, more than 7200 people with SLE have received belimumab in clinical studies, and it is approved in over 75 countries for the treatment of adults with SLE. A subcutaneous, self-injectable belimumab formulation was licensed in 2017 by both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Belimumab was then approved for use in children in Europe, the USA and Japan in 2019, and China and Brazil in 2020. Recently, belimumab became the first FDA-approved drug for the treatment of adults with active lupus nephritis (LN), the most-common severe manifestation of SLE. Over the past 10 years, belimumab has established its position as a disease modifier in the SLE treatment paradigms. Robust evidence from randomised clinical studies and observational, real-world studies has demonstrated the tolerability and efficacy of belimumab for reducing disease activity and the risk of new, severe SLE flares. This enables patients to taper their glucocorticoid use, which limits damage accumulation. Significantly more patients with active LN met the criteria for renal responses and were at less risk of a renal-related event or death after receiving belimumab plus standard therapy, compared with standard therapy on top of mandatory steroid reduction. Ongoing clinical studies are evaluating belimumab’s effectiveness in various indications beyond SLE. Post-marketing and registry studies are gathering additional data on key areas such as pregnancy outcomes after belimumab exposure and belimumab co-administration with other biologics.

show abstract

Section: Belimumab and Patient Reported Outcomesmentioning

confidence: 59%

10 Years of belimumab experience: What have we learnt?

Levy

Gonzalez‐Rivera

Khamashta

et al. 2021

Lupus

Self Cite

View full text Add to dashboard Cite

show abstract

“…Due to the relative strict standards of SRI-4, studies can underestimate the effectiveness of BLM in 'real' world. The OBSErve study, focusing on real-world effectiveness of BLM, verified that BLM could improve the clinical manifestations of SLE (42), thus further supporting the efficacy of BLM in the treatment of SLE.…”

Section: Discussionmentioning

confidence: 70%

Efficacy and safety of belimumab in the treatment of systemic lupus erythematosus: A meta‑analysis

Zhang

Liu

et al. 2022

World Acad Sci J

View full text Add to dashboard Cite

The present meta-analysis aimed to systematically review the efficacy and safety of belimumab (BLM) therapy for patients with active and autoantibody-positive systemic lupus erythematosus (SLE) treated with standard of care (SOC). To evaluate the efficacy and safety of BLM plus SOC treatment in patients with active SLE, eligible studies were retrieved from the Web of Science, The Cochrane Library, PubMed and Embase online databases up to July, 2021. Review Manager (version 5.3) and STATA 16.0 software were used to analyze the extracted data from the included studies. A total of seven randomized controlled trials (RCTs) and 19 case series, with 4,235 and 2,597 patients with SLE, respectively were analyzed. In the RCTs, there were more SLE responder index (SRI-4) responders in the BLM group compared with the control group [52.8 vs. 41.6%; relative risk (RR), 1.27; 95% confidence interval (95% CI), 1.18-1.37); P<0.00001]. In addition, compared with the placebo group, more patients in the BLM group achieved a ≥4-point reduction in the Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index score (RR, 1.26; 95% CI, 1.15-1.38; P<0.00001). Furthermore, treatment with BLM was found to significantly decrease the risk of severe disease exacerbations (flares) compared with the control group (RR, 0.72; 95% CI, 0.63-0.81; P<0.00001). Additionally, the corticosteroid dosage was reduced by ≥25 or 50% to ≤7.5 mg/day during weeks 40-52 in more patients in the BLM group compared with the control group (RR, 1.44; 95% CI, 1.17-1.76; P= 0.0005). However, no differences were observed in the RR of adverse events (AEs) and severe AEs between both groups (RR, 1.00; 95% CI, 0.97-1.02; P= 0.84; and RR, 0.80; 95% CI, 0.62-1.03; P= 0.08, respectively). In the case series studies, the total remission rate was 60.5% (95% CI, 52.1-68.3%; P= 0.015). In addition, treatment with BLM significantly decreased the use of corticosteroids (mean deviation, -8.73; 95% CI, -11.07 to -6.39; P<0.00001). Overall, the results of the present meta-analysis demonstrated that BLM therapy provided significant clinical efficacy and it was well-tolerated by patients with active SLE. More importantly, treatment with BLM may reduce the use of glucocorticoids.

show abstract

“…Blood samples from 40 SLE patients were collected between 26 th of December 2019 and 8 th of May 2021 from the Capital Institute of Pediatrics, Beijing. The SLE cases were divided into three subgroups according to the SLE Disease Activity Index 2000 (SLEDAI-2k): (i) IA subgroup: SLEDAI ≤4; (ii) LA subgroup: SLEDAI=5-9; and (iii) HA subgroup: SLEDAI ≥10 ( 8 , 9 ). HCs were enrolled from children who underwent a health checkup at the Capital Institute of Pediatrics.…”

Section: Methodsmentioning

confidence: 99%

Multi-Platform Omics Analysis Reveals Molecular Signatures for Pathogenesis and Activity of Systemic Lupus Erythematosus

et al. 2022

View full text Add to dashboard Cite

Systemic lupus erythematosus (SLE) is a complex autoimmune disease with heterogeneous clinical manifestations and the pathogenesis of SLE is still unclear. Various omics results have been reported for SLE, but the molecular hallmarks of SLE, especially in patients with different disease activity, using an integrated multi-omics approach have not been fully investigated. Here, we collected blood samples from 10 healthy controls (HCs) and 40 SLE patients with different clinical activity including inactive (IA), low activity (LA), and high activity (HA). Using an integrative analysis of proteomic, metabolomic and lipidomic profiles, we report the multi-omics landscape for SLE. The molecular changes suggest that both the complement system and the inflammatory response were activated in SLEs and were associated with disease activity. Additionally, activation of the immunoglobulin mediated immune response were observed in the LA stage of the disease, however this immune response was suppressed slightly in the HA stage. Finally, an imbalance in lipid metabolism, especially in sphingolipid metabolism, accompanied with dysregulated apolipoproteins were observed to contribute to the disease activity of SLE. The multi-omics data presented in this study and the characterization of peripheral blood from SLE patients may thus help provide important clues regarding the pathogenesis of SLE.

show abstract

Real-World Effectiveness of Belimumab in the Treatment of Systemic Lupus Erythematosus: Pooled Analysis of Multi-Country Data from the OBSErve Studies

Cited by 39 publications

References 21 publications

10 Years of belimumab experience: What have we learnt?

10 Years of belimumab experience: What have we learnt?

Efficacy and safety of belimumab in the treatment of systemic lupus erythematosus: A meta‑analysis

Multi-Platform Omics Analysis Reveals Molecular Signatures for Pathogenesis and Activity of Systemic Lupus Erythematosus

Contact Info

Product

Resources

About