Grabowski David, Henderson Bradley, Lam Dennis, Keystone Edward C, Thorne Carter, Jamal Shahin, Pope Janet, Haraoui Boulos, Lin Daming, Revers Leigh
Institute of Management & Innovation, University of Toronto Mississauga, 3359 Mississauga Road, Mississauga, ON, L5L 1C6, Canada.
Clin Rheumatol. 2015 Aug;34(8):1427-33. doi: 10.1007/s10067-014-2835-4. Epub 2015 Jan 15.
Globally, patents on several well established biologic agents used to treat rheumatic diseases have already or will expire over the next few years, allowing for the availability of subsequent entry biologics (SEBs or biosimilars). The objective of this study was to identify gaps in knowledge and attitudes towards SEBs among Canadian rheumatologists. Eighty-one rheumatologists completed the survey and were included in the analysis (22 % of the 369 who were contacted). We found that one third of physicians (31 %) were familiar with SEBs and that physicians with greater than 20 years of practice were significantly more likely to be familiar or very familiar with SEBs compared to respondents with less than 10 years or 10-20 years of experience (OR 11.1, 95 % CI: 2.1-55.5, p = 0.004 and OR 4.5, 95 % CI: 1.2-16.2, p = 0.023, respectively). A third (32 %) of physicians agreed or strongly agreed that they would be comfortable with indication extrapolation. Most respondents (88 %) would feel concerned or very concerned if a pharmacist had the ability to substitute a biologic drug for an SEB without the physician's approval. This survey was the first study that evaluated the position of rheumatologists on key areas surrounding SEBs from a nationwide Canadian perspective. Current physician attitudes and perceptions of SEBs can inform future educational initiatives and highlight important issues for payers, policy makers, and other stakeholders.
在全球范围内，用于治疗风湿性疾病的几种成熟生物制剂的专利已经或将于未来几年到期，这使得后续进入市场的生物制剂（SEB 或生物类似药）得以面市。本研究的目的是确定加拿大风湿病学家在关于 SEB 的知识和态度方面存在的差距。81 位风湿病学家完成了调查并被纳入分析（占所联系的 369 人的 22%）。我们发现，三分之一的医生（31%）熟悉 SEB，与执业年限少于 10 年或 10 - 20 年的受访者相比，执业超过 20 年的医生更有可能熟悉或非常熟悉 SEB（OR 为 11.1，95% CI：2.1 - 55.5，p = 0.004；OR 为 4.5，95% CI：1.2 - 16.2，p = 0.023）。三分之一（32%）的医生同意或强烈同意他们对适应症外推感到放心。如果药剂师能够在未经医生批准的情况下用生物类似药替代生物制剂，大多数受访者（88%）会感到担忧或非常担忧。这项调查是第一项从加拿大全国范围的角度评估风湿病学家在围绕 SEB 的关键领域立场的研究。目前医生对 SEB 的态度和看法可为未来的教育举措提供参考，并为支付方、政策制定者及其他利益相关者突出重要问题。
