Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
BMJ Open. 2022 Feb 16;12(2):e050949. doi: 10.1136/bmjopen-2021-050949.
To investigate the perceptions and experiences of people with specific immune-mediated inflammatory diseases during the process of switching from Humira to biosimilar adalimumab.
Cross-sectional survey.
An anonymised, self-administered, web-based survey.
The participants were drawn from members and non-members of either the National Rheumatoid Arthritis Society, the National Axial Spondyloarthritis Society, Crohn's and Colitis UK, or Psoriasis Association. Birdshot Uveitis Society and Olivia's Vision also signposted to the survey links.
A total of 899 people living with various immune mediated inflammatory diseases participated in this survey. Thirty-four per cent of respondents reported poor overall satisfaction with their biosimilar adalimumab after the switch, associated with complaints related to the switching process including lack of shared decision making, scarcity of information provided by or signposted to by the department instigating the switch as well as lack of training with the new injection device. Where training with the new device had been provided, there were significantly reduced reports of pain when injecting the new biosimilar (OR 0.20, 95% CI 0.07 to 0.55), side effects (OR 0.17, 95% CI 0.06 to 0.47) and difficulty in using the new injection device (OR 0.25, 95% CI 0.15 to 0.41). Self-reported side effects were reduced by (OR 0.13, 95% CI 0.05 to 0.38) when written information was provided by healthcare professionals and by (OR 0.15, 95% CI 0.05 to 0.42) with provision of verbal information. Difficulty in using the new injection device was also reduced by provision of satisfactory information such as written documents (OR 0.38, 95% CI 0.23 to 0.63) or by verbal communication with healthcare professionals (OR 0.45, 95% CI 0.27 to 0.73). Finally, provision of satisfactory written or verbal information was associated with a reduction in any negative perception regarding symptom control with the new biosimilar by (OR 0.05, 95% CI 0.004 to 0.57) and by (OR 0.15, 95% CI 0.03 to 0.84), respectively.
Patient reported experiences of the process of switching from originator to biosimilar emphasise the importance of clear communication, training and information in order to optimise perception and maximise achievable outcomes with the new treatment.
调查特定免疫介导的炎症性疾病患者在从 Humira 转换为生物类似药阿达木单抗过程中的认知和体验。
横断面调查。
匿名、自我管理的网络调查。
参与者来自全国类风湿关节炎协会、全国轴向脊柱关节炎协会、克罗恩病和结肠炎英国协会、银屑病协会的成员和非成员,或者鸟枪眼葡萄膜炎协会和 Olivia's Vision 也将调查链接指向该调查。
共有 899 名患有各种免疫介导的炎症性疾病的患者参与了这项调查。34%的受访者报告称,在转换后对生物类似药阿达木单抗的总体满意度较差,这与转换过程中的投诉有关,包括缺乏共同决策、负责发起转换的部门提供或指向的信息稀缺以及对新注射装置缺乏培训。在提供新设备培训的情况下,注射新生物类似药时疼痛明显减少(OR 0.20,95%CI 0.07 至 0.55)、副作用(OR 0.17,95%CI 0.06 至 0.47)和使用新注射装置的困难(OR 0.25,95%CI 0.15 至 0.41)。当医护人员提供书面信息时,自我报告的副作用减少(OR 0.13,95%CI 0.05 至 0.38),当提供口头信息时,自我报告的副作用减少(OR 0.15,95%CI 0.05 至 0.42)。使用新注射装置困难也减少,例如提供满意的书面文件(OR 0.38,95%CI 0.23 至 0.63)或与医护人员进行口头沟通(OR 0.45,95%CI 0.27 至 0.73)。最后,提供满意的书面或口头信息与降低新生物类似药治疗对症状控制的任何负面认知有关(OR 0.05,95%CI 0.004 至 0.57)和(OR 0.15,95%CI 0.03 至 0.84)。
患者对从原研药转换为生物类似药过程的报告经验强调了清晰沟通、培训和信息的重要性,以便优化对新治疗的认知并最大限度地提高可实现的结果。