A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus

Abstract

ObjectiveTo evaluate the safety, tolerability and efficacy of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year.MethodsThis was a 24-week, open-label extension following a 52-week, double-blind, placebo-controlled trial of belimumab SC. Patients who completed the double-blind phase were eligible to enter the open-label phase. All patients received weekly belimumab 200 mg SC plus standard SLE therapy. Outcome measures included safety and efficacy (SLE Response Index (SRI) and SLE Flare Index (SFI) rates), and changes in biomarker and B cell levels.ResultsOf 677 patients who completed the 52-week, double-blind phase, 662 entered the open-label phase; 206 had previously received placebo and 456 had previously received belimumab. Despite differences in total belimumab exposure (24 weeks in the placebo-to-belimumab group versus 76 weeks in the belimumab group), the proportions of patients experiencing more than one adverse event (AE) or a serious AE in the open-label phase were similar between groups (placebo-to-belimumab: 51.5 and 6.8%; belimumab: 48.2 and 5.5%, respectively). Most AEs were mild/moderate in severity. Efficacy was maintained through the extension phase. An SRI response was achieved by 16.1% of patients in the placebo-to-belimumab group and 76.3% patients in the belimumab group. Furthermore, 1.0% of patients in the placebo-to-belimumab group and 2.6% of patients in the belimumab group experienced a severe SFI flare.ConclusionBelimumab SC was well tolerated and efficacy was maintained during the extension phase of this study. The safety profile of belimumab SC is consistent with that of previous experience with belimumab.Trial registrationClinicalTrials.gov identifier: NCT01484496

Subcutaneous formulation of belimumab in treatment of systemic lupus erythematosus: a critical review with focus on safety and satisfaction

“…Even after a 24-week extension of treatment, SC belimumab continued to be well tolerated and showed similar adverse events rates with lower treatment discontinuation rate. 45 SC belimumab resulted in less adverse events than IV belimumab; however, this was not statistically significant. 46 …”

“… 44 Moreover, in a 24-week open-label extension study that included 662 patients, SC belimumab continued to show the same efficacy. 45 Efficacy of SC belimumab was not different from IV belimumab when both were indirectly compared. 46 It is important to remember that only SLE patients with moderate to severe disease (score of ≥8 on the Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) were included in all previously mentioned studies.…”

Problems of low activity and remission in systemic lupus erythematosus

“…Неотъемлемой частью современной парадигмы лечения СКВ является таргетная терапия ГИБП, высокоэффективными и не вызывающими повреждения жизненно важных органов. В реальной клинической практике в лечении СКВ используются два ГИБП -белимумаб и ритуксимаб [25][26][27][28][29][30][31]. Применение этих препаратов показано как для быстрого подавления высокой активности с развитием люпус-нефрита, поражения ЦНС, тромбоцитопении и васкулита (ритуксимаб) [29,30], так и для достижения и поддержания ремиссии при поражении суставов кожи, серозных и слизистых оболочек (белимумаб) [25][26][27][28].…”

“…В реальной клинической практике в лечении СКВ используются два ГИБП -белимумаб и ритуксимаб [25][26][27][28][29][30][31]. Применение этих препаратов показано как для быстрого подавления высокой активности с развитием люпус-нефрита, поражения ЦНС, тромбоцитопении и васкулита (ритуксимаб) [29,30], так и для достижения и поддержания ремиссии при поражении суставов кожи, серозных и слизистых оболочек (белимумаб) [25][26][27][28]. Назначение ритуксимаба в дебюте СКВ и комбинированное применение двух ГИБП открывают принципиально новые возможности для достижения ремиссии с минимальным риском развития необратимых органных повреждений [24,26,32].…”

Impact of Recent Clinical Trials on Nephrology Practice: Are We in a Stagnant Era?

“…In a recent double-blinded phase III trial, belimumab (a monoclonal antibody against B lymphocyte stimulator) significantly reduced proteinuria in moderate-to-severe systemic lupus erythematosus patients [50]. Furthermore, belimumab was well tolerated and its efficacy was maintained during the extension phase [51]. …”