Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial

Tanaka, Yoshiya; Bass, Damon; Chu, Myron; Egginton, Sally; Ji, Beulah

doi:10.1080/14397595.2019.1630897

Cited by 11 publications

(7 citation statements)

References 30 publications

(46 reference statements)

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“…[17][18][19][20] The efficacy and safety of belimumab in patients with SLE were examined in previous phase III trials, which demonstrated that belimumab-treated patients have reductions in disease activity, new organ damage accrual and corticosteroid dose. [21][22][23][24] Long-term continuation studies involving 7-13 years of belimumab treatment have confirmed that efficacy and acceptable safety and tolerability profile were maintained over this time. [25][26][27] However, limited data exist on the long-term efficacy and safety of belimumab in patients with SLE from Japan and South Korea.…”

Section: Rmd Open Rmd Open Rmd Openmentioning

confidence: 90%

Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea

et al. 2021

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ObjectivesTo evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) from Japan and South Korea.MethodsIn this phase III, open-label continuation study (BEL114333; NCT01597622), eligible completers of BEL113750 (NCT01345253) or BEL112341 (NCT01484496) received intravenous belimumab 10 mg/kg every 28 days for ≤7 years. Primary endpoint was safety. Secondary endpoints: SLE Responder Index (SRI)4 response rate, proportion of patients meeting individual SRI4 criteria, SLE flares and prednisone use. Analyses were based on observed data from the first belimumab exposure (either in parent or current study) through to study end.ResultsOf 142 enrolled patients who received belimumab, 73.2% completed the study. The study population comprised patients with moderate SLE, mean (SD) Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) baseline score of 9.3 (3.9) and 98.6% receiving corticosteroids. Most patients (97.9%) experienced adverse events (AEs); 33.8% experienced serious AEs. Increase in SRI4 (Year 1, Week 24: 47.8%; Year 6, Week 48: 68.2%) and SELENA-SLEDAI responders suggested reductions in disease activity. Proportions of patients with no worsening in Physician Global Assessment/no new organ damage remained stable throughout. Severe SLE flares occurred in 14.8% of patients. Among patients with baseline prednisone-equivalent dose >7.5 mg/day (n=81), the median (min, max) number of days anytime post-baseline that the daily dose was ≤7.5 mg/day or had been reduced by 50% from baseline was 584 (0, 2267).ConclusionsFavourable safety profile and treatment responses were maintained for ≤7 years in patients with SLE from Japan and South Korea.

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Section: Rmd Open Rmd Open Rmd Openmentioning

confidence: 90%

Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea

et al. 2021

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“…There were 3 reports of Phase II clinical trials, each using a different efficacy index. Two reports by Tanaka et al 30 , 31 were a subgroup analysis of data from only Japanese subjects only recruited in the multi-national BLISS-NEA study, and many indexes were reported. These reports were analyzed after confirming no overlapping of results.…”

Section: Resultsmentioning

confidence: 99%

Usefulness of Belimumab in Adult Patients With Systemic Lupus Erythematosus Evaluated Using Single Indexes: A Meta-Analysis and Systematic Review

Yoshijima,

Suzuki,

Oda

et al. 2024

Current Therapeutic Research

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“…24 The analysis of SLEDAI scores showed a significant improvement in the musculoskeletal, renal and immunological items, a decrease in serum anti-dsDNA antibody titre, an increase in complement activity and a reduction in glucocorticoid dose in the belimumab group compared with the placebo group. 25 The BLISS-SC (ClinicalTrials.gov Identifier: NCT01484496) study investigated 836 patients with SLE and a SLEDAI score of ≥8, and reported that the proportion of patients achieving SRI-4 response at 52 weeks was significantly higher in the belimumab group (200 mg subcutaneous injection once weekly) than in the placebo group (61% versus 48%). 26 The safety profile was unremarkable.…”

Section: Belimumab Therapy In Systemic Lupus Erythematosusmentioning

confidence: 99%

Belimumab: A BAFF-specific Inhibitor for the Treatment of Systemic Lupus Erythematosus and Lupus Nephritis

Tanaka¹

2022

Rheumatology

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Systemic lupus erythematosus (SLE) is a systemic autoimmune disease that affects multiple organs. In particular, the presence of renal involvement, known as lupus nephritis, is a major determinant of prognosis. Conventional treatments for SLE include hydroxychloroquine, glucocorticoid and immunosuppressive agents. However, the use of such non-specific drugs increases the risk of side effects, such as infections. Soluble B-cell-activating factor (BAFF), belonging to the tumour necrosis factor family, is produced by dendritic cells and induces class switching of B cells and differentiation into antibody-producing cells. International phase III studies demonstrated the efficacy and safety of belimumab (a monoclonal antibody against soluble BAFF) not only in patients with SLE, but also in those with active lupus nephritis. There were no significant differences between the belimumab and placebo groups in the incidence of adverse events, including serious events and events necessitating drug cessation. Thus, belimumab could become an alternative induction treatment for lupus nephritis. This article describes the pathogenesis of SLE and lupus nephritis, and reviews the results of recent phase III trials of belimumab and its promising role for the treatment of patients.

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Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial

Abstract: Roth (2020) Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial,

Cited by 11 publications

References 30 publications

Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea

Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea

Usefulness of Belimumab in Adult Patients With Systemic Lupus Erythematosus Evaluated Using Single Indexes: A Meta-Analysis and Systematic Review

Belimumab: A BAFF-specific Inhibitor for the Treatment of Systemic Lupus Erythematosus and Lupus Nephritis

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