Biogen International GmbH, Zug, Switzerland.
Adv Ther. 2018 Jun;35(6):749-753. doi: 10.1007/s12325-018-0719-8. Epub 2018 Jun 5.
In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice. These opinions can be transferred to patients through poor or lack of communication, meaning that patients may lack confidence in treatment quality and, as a result, be susceptible to the nocebo effect. At the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting, during a debate the question was asked as to whether the nocebo effect was in fact being used to describe "any result you don't agree with". Here, we detail that the nocebo effect has been demonstrated in a number of clinical trials, and that this effect may negatively affect acceptance in patients switching from an originator product to a biosimilar. Awareness of the potential for the nocebo effect and adoption of enhanced communication techniques may be useful in mitigating the nocebo effect. Effective healthcare professional-patient dialogue is key in transferring confidence to the patient, and has been shown to reduce nocebo effects in patients when switching from an originator to a biosimilar.
Biogen International GmbH.
除了提供一般的临床益处外，生物类似药不仅可以为医疗保健预算节省资金，还可以改善患者获得生物制品的机会。自 2006 年欧洲批准首个生物类似药以来，又有 36 种不同的生物类似药获批用于多种适应症。尽管已经积累了丰富的经验，并且有数据报告支持生物类似药在初治和生物制剂经验丰富的患者中的使用，但一些医疗保健专业人员仍然对生物类似药严格的审批程序表示怀疑，并且不确定如何将其纳入日常临床实践。这些观点可以通过沟通不畅或缺乏沟通传递给患者，这意味着患者可能对治疗质量缺乏信心，因此容易受到安慰剂效应的影响。在 2017 年美国风湿病学会/风湿病卫生专业人员协会年会上，在一次辩论中，有人问，安慰剂效应是否实际上被用来描述“任何你不同意的结果”。在这里，我们详细说明了安慰剂效应已在多项临床试验中得到证实，并且这种效应可能会对从原研产品转为生物类似药的患者的接受程度产生负面影响。意识到可能存在安慰剂效应，并采用增强沟通技巧可能有助于减轻安慰剂效应。有效的医疗保健专业人员与患者之间的对话是向患者传递信心的关键，并且已经证明，在从原研药转为生物类似药时，这种对话可以减少患者的安慰剂效应。
Biogen International GmbH。
