一项评估德国医生和患者接受生物仿制药治疗RA、AS和PsA的研究
目的:调查医生使用生物仿制药品的原因,评估其选择治疗方案的偏好并调查患者对仿生物药品的态度。
方法:本研究来自2015-2016年斯特兰德生物仿制药品使用的现实世界数据,与德国专家和患者进行横断面研究RA、AS或PsA患者使用生物仿制药品的真实数据。风湿病专家提供其生物仿制药处方行为和态度的数据并邀请能完成该研究的8个患者连续完成一份调查问卷。风湿病专家被分为“调查”、“保守”和“其他”组。
结果:50名风湿病专家,261名患者参与此项调查。生物治疗处方中生物仿制药占10%,95%的专家会开生物制剂原研药而不是生物仿制药,生物仿制药非第一选择。患者表现出不愿接受生物仿制药品,一小部分患者非常不情愿将原研药换成生物仿制药品。患者满意度最高的治疗是首选原研药。25%-41%的患者担心开始治疗时包括对原研药或生物仿制药物不够了解,26%-32%担心潜在的副作用,19%-30%担心长期使用的问题。
结论:研究结果表明,教育不愿接受生物仿制药的患者参与治疗的决策中,强调病人和医生沟通的重要性。仍需要进一步的对仿生物药品的长期研究。
Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across germany
John Waller.et al
Objectives:We examined rheumatologists’ motivation for prescribing biosimilars, assessedtheir treatment preferences in relation to prescribing behavior and explored patient attitudesto biosimilars.
Methods:Data were taken from the Adelphi Real World Biosimilars Programme, a real-world,cross-sectional study undertaken with German rheumatologists and patients with rheumatoidarthritis, ankylosing spondyloarthritis or psoriatic arthritis in 2015–2016. Rheumatologistsprovided data on their prescribing behavior and attitudes toward biosimilars and invited thenext eight eligible consecutive consulting patients to complete a questionnaire. Rheumatologistswere split into “investigative”, “conservative” and “other” groups.
Results:Overall, 50 rheumatologists and 261 patients participated. Biosimilars accountedfor ,10% of all biologic therapy prescriptions, and .95% of rheumatologists would prescribea biooriginator rather than biosimilar as the first- or second-line therapy if unrestricted. Patientsshowed some reluctance to accept biosimilars, and a small proportion of patients were unhappywhen switched from a biooriginator to a biosimilar. Satisfaction with treatment was highestin patients who started treatment with a biooriginator prior to biosimilar availability. Patientconcerns when starting treatment with a biooriginator or a biosimilar included not knowingenough about the drug (25%–41%), potential side effects (26%–32%) and potential long-termproblems (19%–30%).
Conclusion:Study results demonstrate that there is some reluctance from patients to acceptbiosimilars and the need to educate patients who are unsure to allow them to be involved indecision making, highlighting the importance of patient and physician communication. Thereremains a need for further research into nonclinical switching and the long-term impact ofprescribing biosimilars.
Patient Preference and Adherence 2017:11 519–530
翻译者:韩青,空军军医大学附属西京医院临床免疫科
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