Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Park, Min Chan; Matsuno, Hiroaki; Kim, Jinseok; Park, Sung Hwan; Lee, Sang‐Heon; Park, Yong Bum; Lee, Yun Jong; Lee, Sang Il; Park, Won; Sheen, Dong‐Hoon; Choe, Jung Yoon; Choi, Chan Bum; Hong, Seung Jae; Suh, Chang Hee; Lee, Shin Seok; Suk, Hoon; Yoo, Bin; Hur, Jin; Kim, Geun Tae; Yoo, Wan Hee; Baek, Han Joo; Shin, Kichul; Shim, Seung Cheol; Yang, Haesik; Kim, Hyun Ah; Park, Kyung Su; Choi, In Ah; Lee, Sang Hoon; Tomomitsu, Masato; Shin, Seung-Il; Lee, Ji-Yoon; Song, Yeong Wook

doi:10.1186/s13075-019-1910-2

Cited by 14 publications

(35 citation statements)

References 24 publications

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“…There were no immunogenicity concerns after switching from the ETN-RP to a biosimilar or in patients continuing with LBEC0101. Injection site reactions were lower than reported in the preceding double-blind Phase III study, possibly because of the finer 29G needle used in the extension study [42] compared with the 27G needle used in the Phase III study [39,47,48]. Overall, the safety profile for LBEC0101 was maintained from the Phase III double-blind study, for both maintenance and switch groups, with no notable differences between groups and no new safety concerns.…”

Section: Safety and Tolerabilitymentioning

confidence: 73%

“…In the subsequent Phase III extension study, there were similar incidences of AEs, serious AEs, ADRs, and serious ADRs in patients after continued therapy or after switching from the ETN-RP to LBEC0101 (Table 2) [42]. There were no immunogenicity concerns after switching from the ETN-RP to a biosimilar or in patients continuing with LBEC0101.…”

Section: Safety and Tolerabilitymentioning

confidence: 78%

“…In the double-blind Phase III study, 93.3% and 86.7% ACR20 responses were reported for LBEC0101 and ETN-RP groups, respectively, at week 24 [39]. The global study with the SB4 biosimilar reported respective ACR20 responses of 78.1% and 80.3% for SB4 and ETN-RP groups [42], and the EQUIRA study reported respective ACR20 responses of 88.0% and 92.9% for GP2015 and ETN-RP groups [44]; all at week 24. Lower incidence rates of injection site reactions were reported for etanercept biosimilars compared to the ETN-RP.…”

Section: Resultsmentioning

confidence: 97%

“…In an extension study, conducted in Korea only, patients who were treated with the ETN-RP during the randomized controlled Phase III study switched to LBEC0101 (switch group, n = 78), while those treated with LBEC0101 continued to receive LBEC0101 (maintenance group, n = 70) (NCT02715908) [42]. The efficacy of LBEC0101 was assessed up to week 100 in the extension study.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…As of August 2019, LBEC0101 (Box 1) is sold in South Korea and Japan (both approved in 2018) for RA in adults and juvenile idiopathic arthritis in pediatric patients [40], and additionally in South Korea for psoriatic arthritis, axial spondyloarthritis, and psoriasis in adults [41]. This figure is adapted from Figure 2 of the Phase III extension study manuscript [42] in compliance with the terms of the Creative Commons Attribution 4.0 International (CC BY 4.0) license. † ± standard error.…”

Section: Regulatory Affairsmentioning

confidence: 99%

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LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

Song

Park

Kim

2019

Expert Opinion on Biological Therapy

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Section: Safety and Tolerabilitymentioning

confidence: 73%

Section: Safety and Tolerabilitymentioning

confidence: 78%

Section: Resultsmentioning

confidence: 97%

Section: Clinical Efficacymentioning

confidence: 99%

Section: Regulatory Affairsmentioning

confidence: 99%

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LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

Song

Park

Kim

2019

Expert Opinion on Biological Therapy

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Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

et al. 2023

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ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA).ObjectivesTo assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA.Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021.Study SelectionHead-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed.Data Extraction and SynthesisTwo authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes, with 95% credible intervals (CrIs) and trial sequential analysis. Specific domains were assessed for the risk of bias in equivalence and noninferiority trials. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline.Main Outcomes and MeasuresEquivalence was tested using prespecified margins for the American College of Rheumatology criteria, with at least 20% improvement in the core set measures (ACR20) (ie, RR, 0.94 to 1.06), and for the Health Assessment Questionnaire–Disability Index (HAQ-DI) (ie, SMD, −0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity.ResultsA total of 25 head-to-head trials provided data on 10 642 randomized patients with moderate to severe RA. Biosimilars met equivalence with reference biologics in terms of ACR20 response (24 RCTs with 10 259 patients; RR, 1.01; 95% CrI, 0.98 to 1.04; τ2 = 0.000) and change of HAQ-DI scores (14 RCTs with 5579 patients; SMD, −0.04; 95% CrI, −0.11 to 0.02; τ2 = 0.002) considering prespecified margins of equivalence. Trial sequential analysis found evidence for equivalence for ACR20 since 2017 and HAQ-DI since 2016. Overall, biosimilars were associated with similar safety and immunogenicity profiles compared with reference biologics.Conclusion and RelevanceIn this systematic review and meta-analysis, biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of RA.

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Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

et al. 2019

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Biosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the "totality of evidence" concept, an approach that considers data from structural and functional characterization and comparability analysis and non-clinical and clinical studies. For biosimilar filgrastim, phase III confirmatory clinical studies were performed in the most sensitive population, patients with breast cancer undergoing myelosuppressive chemotherapy. In Europe and the USA, approval was granted for all indications of the reference biologic. Hence, stem cell mobilization and severe chronic neutropenia indications were approved on the basis of extrapolation, with no clinical data available at the time of market authorization in the EU. Although extrapolation is well-accepted in biologic development and regulatory contexts, it remains a misunderstood part of the biosimilarity concept in the medical community. Since approval, more than a decade of obtained clinical experience supports the totality of evidence and reassures clinicians regarding the efficacy and safety of biosimilar filgrastim. This includes real-world data from MONITOR-GCSF, a multicenter, prospective, observational study describing treatment patterns and clinical outcomes of patients with cancer (n = 1447) receiving biosimilar filgrastim for the prophylaxis of chemotherapy-induced neutropenia in solid tumors and hematological malignancies. Evidence is also available from unrelated healthy donors and those with severe chronic neutropenia. Together, the experience from a decade of use of biosimilar filgrastim includes over 24 million patient-days of exposure, which can help reassure oncologists that extrapolation is based on strong scientific evidence and works in practice.

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Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Cited by 14 publications

References 24 publications

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

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