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评估德国各地胃肠病学家和患者对溃疡性结肠炎和克罗恩病生物类似药的接受度。

Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany.

作者信息

Sullivan Emma, Piercy James, Waller John, Black Christopher M, Kachroo Sumesh

机构信息

Adelphi Real World, Manchester, United Kingdom.

Merck & Co., Inc., Kenilworth, NJ, United States of America.

出版信息

PLoS One. 2017 Apr 14;12(4):e0175826. doi: 10.1371/journal.pone.0175826. eCollection 2017.

Abstract

OBJECTIVES

This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars.

METHODS

Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken in 2015-2016 with German gastroenterologists and patients with ulcerative colitis or Crohn's disease. Gastroenterologists provided data on their prescribing behaviour and attitudes towards biosimilars, and invited the next eight eligible consecutive consulting patients to complete a detailed questionnaire. For analysis, gastroenterologists were split into 'Investigative', 'Conservative', and 'Other' groups.

RESULTS

Overall, 25 gastroenterologists and 136 patients participated. Biosimilars accounted for <15% of all biologic therapies and >80% of gastroenterologists would prescribe a bio-originator rather than biosimilar as 1st line therapy if unrestricted. Patients showed some reluctance to accept biosimilars, although of those receiving biosimilars, 79% were satisfied with the current treatment of their condition, and 69% were satisfied with the control of symptoms. Although at least 35% of patients in each analysis group reported no concerns when starting treatment with a bio-originator or biosimilar, 41% of previously biologic-naïve patients prescribed a biosimilar indicated potential side effects and potential long-term problems, and 24% not knowing enough about the drug, as concerns.

CONCLUSION

Results demonstrate that there is reluctance from patients to accept biosimilars and the need to further educate patients who are unsure to allow them to be involved in decision making, highlighting the importance of patient and physician communication. There remains a need for further research into non-clinical switching and the long term impact of prescribing biosimilars.

摘要

目的

本研究调查了胃肠病学家开具生物类似药的动机,评估了他们在处方行为方面的治疗偏好,并探究了患者对生物类似药的态度。

方法

数据取自阿德尔菲真实世界生物类似药项目,这是一项在2015 - 2016年对德国胃肠病学家以及溃疡性结肠炎或克罗恩病患者开展的真实世界横断面研究。胃肠病学家提供了他们的处方行为和对生物类似药的态度数据,并邀请接下来连续8名符合条件的咨询患者填写一份详细问卷。为进行分析,胃肠病学家被分为“探究型”、“保守型”和“其他”组。

结果

总体而言,25名胃肠病学家和136名患者参与了研究。生物类似药在所有生物治疗中占比不到15%,超过80%的胃肠病学家表示,如果没有限制,他们会将生物原研药而非生物类似药作为一线治疗药物开具。患者对接受生物类似药表现出一定的抵触情绪,不过在接受生物类似药治疗的患者中,79%对当前病情的治疗感到满意,69%对症状控制感到满意。尽管在每个分析组中至少35%的患者表示在开始使用生物原研药或生物类似药治疗时没有顾虑,但在使用生物类似药的初治患者中,41%表示担心潜在的副作用和潜在的长期问题,24%表示对药物了解不足。

结论

结果表明患者对接受生物类似药存在抵触情绪,需要进一步对不确定的患者进行教育,让他们参与决策,这凸显了医患沟通的重要性。对于非临床换药以及开具生物类似药的长期影响,仍需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/449b/5391967/169be771b9c9/pone.0175826.g001.jpg

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