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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.
2
Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study.中重度溃疡性结肠炎患者使用预填充注射器或自动注射装置给药戈利木单抗的偏好:一项随机交叉研究。
Patient Prefer Adherence. 2018 Jul 6;12:1193-1202. doi: 10.2147/PPA.S154181. eCollection 2018.
3
Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect.生物类似药的治疗效果:谨防反安慰剂效应。
Rheumatol Ther. 2017 Dec;4(2):209-218. doi: 10.1007/s40744-017-0085-z. Epub 2017 Oct 14.
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Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.治疗风湿性疾病的生物类似药使用共识推荐。
Ann Rheum Dis. 2018 Feb;77(2):165-174. doi: 10.1136/annrheumdis-2017-211937. Epub 2017 Sep 2.
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A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry.一项针对 802 例炎症性关节炎患者的全国性非医学性从原研英夫利昔单抗转换为生物类似药 CT-P13 的研究:DANBIO 注册研究的 1 年临床结果。
Ann Rheum Dis. 2017 Aug;76(8):1426-1431. doi: 10.1136/annrheumdis-2016-210742. Epub 2017 May 4.
6
Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across Germany.评估德国各地医生和患者对类风湿性关节炎、强直性脊柱炎和银屑病关节炎中英夫利昔单抗生物类似药的接受度。
Patient Prefer Adherence. 2017 Mar 13;11:519-530. doi: 10.2147/PPA.S129333. eCollection 2017.
7
Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali) Versus Etanercept (Enbrel) - Findings from a Nurse Survey in Europe.两种用于类风湿关节炎的依那西普自动注射器的认知与偏好:一种新的欧盟批准的依那西普生物类似药(贝那利单抗)与依那西普(恩利)——欧洲一项护士调查的结果
Rheumatol Ther. 2016 Jun;3(1):77-89. doi: 10.1007/s40744-016-0035-1. Epub 2016 May 23.
8
A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy.一项III期随机、双盲、平行组研究,在尽管接受甲氨蝶呤治疗但仍患有活动性类风湿关节炎的患者中,将SB4与依那西普参比产品进行比较。
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患者满意度调查:用生物类似药替代参照依那西普。

Patient satisfaction survey: substitution of reference etanercept with a biosimilar product.

机构信息

Pharmacy Department, Hospital de Cabueñes, Gijon, Spain

Pharmacy Department, Hospital de Cabueñes, Gijon, Spain.

出版信息

Eur J Hosp Pharm. 2021 Mar;28(2):109-111. doi: 10.1136/ejhpharm-2019-001999. Epub 2019 Sep 4.

DOI:10.1136/ejhpharm-2019-001999
PMID:33608440
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7907693/
Abstract

OBJECTIVES

To assess patient satisfaction after pharmacy-mediated replacement of the originator etanercept prefilled syringe with its biosimilar prefilled pen.

METHODS

Prospective observational study from March to May 2018, to assess satisfaction with the new drug dispensed. Patients were asked to answer a paper questionnaire with three questions: pain at injection site, ease of administration, and overall patient satisfaction with the change, rated on a scale from 1 (not satisfied) to 5 (extremely satisfied).

RESULTS

The questionnaire was given to 134 patients (74 men, 60 women), with an average age of 55 years. 118 patients (88%) were from the Rheumatology Service and 16 patients (12%) from Dermatology. The median treatment duration with etanercept was 61 months. 87 (65%) completed questionnaires were collected. The mean pain score was 3.4. Most patients found administration easy with the biosimilar pen, with an average score of 3.7. Mean overall satisfaction was rated at 3.3, being higher among men, younger patients, and those with shorter duration of treatment.

CONCLUSIONS

The change of the original product from etanercept to a biosimilar product was acceptable for most of the patients who responded to the survey. Surveys allow us to determine the opinion and preferences of patients, thus achieving higher satisfaction with their treatment. Further research is needed to evaluate the effect of automatic replacement. A collaborative multidisciplinary switching programme should be implemented based on the feedback provided by patients.

摘要

目的

评估药房介导将依那西普预装注射器更换为生物类似药预装笔后患者的满意度。

方法

这是一项 2018 年 3 月至 5 月进行的前瞻性观察研究,旨在评估患者对新发放药物的满意度。患者需回答纸质问卷上的三个问题:注射部位疼痛、给药便利性以及对药物更换的整体满意度,评分范围为 1(不满意)至 5(非常满意)。

结果

共向 134 名患者(74 名男性,60 名女性)发放了问卷,平均年龄为 55 岁。118 名(88%)患者来自风湿科,16 名(12%)患者来自皮肤科。使用依那西普的中位治疗时间为 61 个月。共收集到 87 份(65%)完成的问卷。平均疼痛评分为 3.4。大多数患者认为生物类似药笔给药较容易,平均评分为 3.7。总体满意度平均评分为 3.3,男性、年轻患者和治疗时间较短的患者满意度更高。

结论

对于大多数参与调查的患者来说,将依那西普原研药更换为生物类似药是可以接受的。调查可以帮助我们了解患者的意见和偏好,从而提高其对治疗的满意度。需要进一步研究来评估自动替换的效果。应根据患者提供的反馈,实施协作的多学科转换计划。