Efficacy and safety of belimumab during maintenance therapy in patients with systemic lupus erythematosus

Miyazaki, Yusuke; Nakayamada, Shingo; Sonomoto, Koshiro; Kawabe, Akio; Inoue, Yoshino; Okubo, Naoaki; Iwata, S.; Hanami, Kentaro

doi:10.1093/rheumatology/keab953

Cited by 15 publications

(10 citation statements)

References 39 publications

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“…Notably, no discontinuation due to a lack of e cacy was observed in both groups, suggesting that BLM may have characteristics similar to HCQ. The current ndings indicate that BLM has a high safety pro le, as noted in a previous study [18,19,32]. While similar comparisons need to be made for immunosuppressive agents and other biologic agents, at this stage, BLM seems the most reasonable treatment alternative for patients who cannot tolerate HCQ because of adverse effects or concerns about cumulative dosage.…”

Section: Discussionsupporting

confidence: 75%

Comparative efficacy and safety of belimumab and hydroxychloroquine in the maintenance phase in patients with systemic lupus erythematosus: a retrospective cohort study

Kimura,

Ayano,

Ota

et al. 2023

Preprint

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Background Hydroxychloroquine (HCQ), a cornerstone drug, is recommended for long-term use in treating systemic lupus erythematosus (SLE). However, in cases where HCQ is unavailable, it is unclear which drugs should be prioritised for continuation. We aimed to clarify whether belimumab (BLM), which has recently been reported to have long-term safety and efficacy, could be a viable alternative to HCQ. Methods We retrospectively compared the efficacy, drug continuation rate and safety of HCQ and BLM in the maintenance phase in patients with SLE. The efficacy endpoints were the cumulative incidence of flares over 2 years, the increase in the damage index and the changes in the SLE Disease Activity Index 2000 (SLEDAI) score and prednisolone dose. The safety endpoint was the adverse event rates. Results Among 96 patients analysed, 15 out of 84 patients (17.9%) in the HCQ group and 1 out of 12 patients (8.3%) in the BLM group experienced a flare with no significant difference in the cumulative incidence of flares between the two groups (p = 0.47). No differences were observed in the cumulative incidence of the increase in the damage index, changes in the SLEDAI score and prednisolone dose, drug continuation rates and adverse events. Conclusions The efficacy and safety of BLM were similar to those of HCQ. BLM could be a valuable treatment option for patients with SLE, either as a cornerstone SLE therapy or as an alternative for those who cannot tolerate HCQ.

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Section: Discussionsupporting

confidence: 75%

Comparative efficacy and safety of belimumab and hydroxychloroquine in the maintenance phase in patients with systemic lupus erythematosus: a retrospective cohort study

Kimura,

Ayano,

Ota

et al. 2023

Preprint

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“…One recent study in patients with SLE, of which just under half had LN class I–V, reported that belimumab, in combination with ST, during maintenance therapy significantly reduced corticosteroid dose and prevented relapse of LN when compared with ST, in a real-world clinical setting. 60 …”

Section: Discussionmentioning

confidence: 99%

“…One recent study in patients with SLE, of which just under half had LN class I-V, reported that belimumab, in combination with ST, during maintenance therapy significantly reduced corticosteroid dose and prevented relapse of LN when compared with ST, in a real-world clinical setting. 60 There remains a knowledge gap on whether belimumab is superior to ST for maintaining the response achieved during induction therapy and preventing renal flares, which is an important goal of maintenance therapy in LN. 8 To address this, the MOONLIGHT study will evaluate the real-world clinical effectiveness of belimumab in combination with ST in Japanese patients with a history of biopsy-diagnosed active LN using real-world clinical data from a nationwide surveillance study and a multicentre registry.…”

Section: Discussionmentioning

confidence: 99%

“…However, few studies have evaluated the effect of belimumab when administered during the maintenance phase and later in patients with a history of biopsy-proven active LN. One recent study in patients with SLE, of which just under half had LN class I–V, reported that belimumab, in combination with ST, during maintenance therapy significantly reduced corticosteroid dose and prevented relapse of LN when compared with ST, in a real-world clinical setting 60…”

Section: Discussionmentioning

confidence: 99%

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MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT

et al. 2022

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IntroductionLupus nephritis (LN) is more prevalent in patients with SLE of Asian ethnicity than in Caucasian patients. Belimumab became available in Japan in 2017 to treat patients with SLE, including those with LN. In the BLISS-LN trial (NCT01639339), belimumab showed a favourable effect on renal outcomes when combined with standard therapy (ST) starting at the induction treatment phase for active LN, but real-world effectiveness of belimumab in LN has not been extensively studied. Here we describe the protocol for the MOONLIGHT (post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide ReGistry (LUNA) coHorT) study, which will use data from a Japan postmarketing surveillance study and the Lupus Registry of Nationwide Institutions (LUNA) to evaluate the real-world effectiveness of belimumab plus ST versus ST alone in patients with a history of active LN who are not in the induction phase.Methods and analysisThis multicentre, retrospective, observational study (GSK Study 214710) will enrol adults with SLE and a history of active LN, holding ≥3 years of complete follow-up data from the initiation of belimumab (no continuous treatment required). Data for patients with belimumab plus ST treatment (postmarketing registry data, belimumab cohort) will be compared with those for patients with ST only treatment (LUNA data, comparison cohort). Patients who discontinue/initiate belimumab after the start of the follow-up may be included in the comparison/belimumab cohort, respectively. The primary endpoint will be the occurrence of renal flares, for which belimumab’s effectiveness will be estimated using a marginal structural model to consider time-dependent treatment and confounding factors. Secondary endpoints will include change in corticosteroid dose, renal disease activity, extrarenal disease activity, disease severity/activity biomarkers, LN class changes, end-stage kidney disease events and hospitalisations.Ethics and disseminationThis study will be conducted according to the Declaration of Helsinki and the local ethical guidelines. Findings will be submitted to peer-reviewed journals and presented at scientific meetings.

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“…30 Another study also reported that the addition of belimumab to standard-of-care treatment was effective in reducing glucocorticoids, preventing relapse of disease activity and preventing the progression of organ damage in patients with SLE during maintenance therapy after obtaining remission or low disease activity. 31 These findings may be important aspects in the treat-to-target context during maintenance therapy for SLE.…”

Section: Belimumab Therapy In Systemic Lupus Erythematosusmentioning

confidence: 93%

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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Efficacy and safety of belimumab during maintenance therapy in patients with systemic lupus erythematosus

Cited by 15 publications

References 39 publications

Comparative efficacy and safety of belimumab and hydroxychloroquine in the maintenance phase in patients with systemic lupus erythematosus: a retrospective cohort study

Comparative efficacy and safety of belimumab and hydroxychloroquine in the maintenance phase in patients with systemic lupus erythematosus: a retrospective cohort study

MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT

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

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