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Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis.

作者信息

Piaserico Stefano, Conti Andrea, Messina Francesco, Meneguzzo Alberto, Odorici Giulia, Bellinato Francesco, Gisondi Paolo

机构信息

Section of Dermatology and Venereology, Unit of Dermatology, Department of Medicine, University of Padua, Via V. Gallucci 4, 35128, Padua, Italy.

Dermatologic Unit, Department of Specialized Medicine, AOU Policlinico di Modena, Modena, Italy.

出版信息

BioDrugs. 2021 Jul;35(4):469-471. doi: 10.1007/s40259-021-00485-8. Epub 2021 May 11.

DOI:10.1007/s40259-021-00485-8
PMID:33974243
Abstract
摘要

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1
Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis.慢性斑块状银屑病患者从原研药依那西普转换为生物类似药SB4和GP2015的交叉转换
BioDrugs. 2021 Jul;35(4):469-471. doi: 10.1007/s40259-021-00485-8. Epub 2021 May 11.
2
The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis.EGALITY 研究：一项在中重度慢性斑块型银屑病患者中比较 GP2015（一种拟生物类似药）与原研药物的疗效、安全性和免疫原性的确证性、随机、双盲研究。
Br J Dermatol. 2017 Apr;176(4):928-938. doi: 10.1111/bjd.15152. Epub 2017 Mar 1.
3
GP2015: An Etanercept Biosimilar.GP2015：一种依那西普生物类似药。
BioDrugs. 2017 Dec;31(6):555-558. doi: 10.1007/s40259-017-0246-1.
4
Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study.在慢性斑块型银屑病患者中，GP2015（一种依那西普生物类似药）与原研药之间的多次转换不会影响疗效、安全性和免疫原性：来自 3 期、确证性 EGALITY 研究的 30 周结果。
J Eur Acad Dermatol Venereol. 2018 Mar;32(3):420-427. doi: 10.1111/jdv.14605. Epub 2017 Nov 2.
5
Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review.在类风湿关节炎和银屑病试验中，原研 TNF 抑制剂和生物类似药的疗效和安全性结局：系统文献回顾。
BioDrugs. 2018 Jun;32(3):193-199. doi: 10.1007/s40259-018-0283-4.
6
Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel(®)).与原研药依那西普（恩利（®））比较，新型依那西普生物类似药 GP2015 的特征与非临床评估。
Expert Opin Biol Ther. 2016 Oct;16(10):1185-95. doi: 10.1080/14712598.2016.1217329. Epub 2016 Aug 16.
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Costs associated with non-medical switching from originator to biosimilar etanercept in patients with rheumatoid arthritis in the UK.英国类风湿关节炎患者从原研药转换为生物类似药依那西普的非医学相关费用。
J Med Econ. 2019 Nov;22(11):1162-1170. doi: 10.1080/13696998.2019.1652183. Epub 2019 Sep 9.
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Acceptance rate and sociological factors involved in the switch from originator to biosimilar etanercept (SB4).从原研药到生物类似药依那西普（SB4）转换过程中的接受率和社会学因素。
Semin Arthritis Rheum. 2019 Apr;48(5):927-932. doi: 10.1016/j.semarthrit.2018.07.005. Epub 2018 Jul 20.
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Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study.开放性、非强制性由依那西普原研药转换为生物类似药 SB4：一项对照队列研究的 6 个月结果。
Arthritis Rheumatol. 2018 Sep;70(9):1408-1418. doi: 10.1002/art.40516. Epub 2018 Aug 6.
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Real World SB4 (Etanercept Biosimilar) Use in Patients With Psoriasis: Data from the British Association of Dermatologists Biologic Interventions Register (BADBIR).真实世界 SB4（依那西普生物类似药）在银屑病患者中的应用：来自英国皮肤科医师协会生物制剂干预登记处（BADBIR）的数据。
J Drugs Dermatol. 2020 Mar 1;19(3):316-318.

引用本文的文献

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Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching.扩大患者群体和新适应症中的更多数据支持生物类似药之间换药的做法。
BioDrugs. 2024 May;38(3):331-339. doi: 10.1007/s40259-024-00655-4. Epub 2024 Mar 23.
2
Switching Among Biosimilars: A Review of Clinical Evidence.生物类似药之间的转换：临床证据综述
Front Pharmacol. 2022 Aug 24;13:917814. doi: 10.3389/fphar.2022.917814. eCollection 2022.
3
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.

本文引用的文献

1
The impact of the COVID-19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience.2019年冠状病毒病大流行对接受生物疗法治疗的慢性斑块状银屑病患者的影响：意大利北部的经验。
Br J Dermatol. 2020 Aug;183(2):373-374. doi: 10.1111/bjd.19158. Epub 2020 May 28.
2
Effects of successive switches to different biosimilars infliximab on immunogenicity in chronic inflammatory diseases in daily clinical practice.在日常临床实践中，连续改用不同英夫利昔单抗生物类似药对慢性炎症性疾病免疫原性的影响。
Semin Arthritis Rheum. 2020 Dec;50(6):1449-1456. doi: 10.1016/j.semarthrit.2020.02.007. Epub 2020 Feb 19.
3
从一种生物类似药切换至同一种参照生物制品的另一种生物类似药：研究的系统评价。
BioDrugs. 2022 Sep;36(5):625-637. doi: 10.1007/s40259-022-00546-6. Epub 2022 Jul 26.
4
Secukinumab Loss of Efficacy Is Perfectly Counteracted by the Introduction of Combination Therapy (Rescue Therapy): Data from a Multicenter Real-Life Study in a Cohort of Italian Psoriatic Patients That Avoided Secukinumab Switching.通过引入联合治疗（挽救治疗）可完美抵消司库奇尤单抗的疗效丧失：来自一项针对意大利银屑病患者队列的多中心真实世界研究的数据，该研究避免了司库奇尤单抗的换药。
Pharmaceuticals (Basel). 2022 Jan 14;15(1):95. doi: 10.3390/ph15010095.
Immunogenicity of TNF-Inhibitors.
肿瘤坏死因子抑制剂的免疫原性。
Front Immunol. 2020 Feb 26;11:312. doi: 10.3389/fimmu.2020.00312. eCollection 2020.
4
Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis.抗肿瘤坏死因子-α生物类似药治疗银屑病的安全性和有效性。
Am J Clin Dermatol. 2020 Aug;21(4):483-491. doi: 10.1007/s40257-020-00507-1.
5
Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis.中重度斑块型银屑病生物制剂和生物类似药的安全性、疗效和药物存续性。
Br J Dermatol. 2018 Feb;178(2):509-519. doi: 10.1111/bjd.16102. Epub 2018 Jan 9.
6
Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study.在慢性斑块型银屑病患者中，GP2015（一种依那西普生物类似药）与原研药之间的多次转换不会影响疗效、安全性和免疫原性：来自 3 期、确证性 EGALITY 研究的 30 周结果。
J Eur Acad Dermatol Venereol. 2018 Mar;32(3):420-427. doi: 10.1111/jdv.14605. Epub 2017 Nov 2.
7
The nocebo effect of drugs.药物的反安慰剂效应。
Pharmacol Res Perspect. 2016 Mar 17;4(2):e00208. doi: 10.1002/prp2.208. eCollection 2016 Apr.