A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS).

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY International Journal of Clinical Pharmacy Pub Date : 2024-10-01 Epub Date: 2024-05-11 DOI:10.1007/s11096-024-01739-5

David Young, Clare Harris, Sohail Rahmany, Inês Iria, João Gonçalves, Janet Addison, Justin Harvey, Sue Latter, Fraser Cummings

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Abstract

Background: Patient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition.

Aim: The aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5).

Method: iBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24 weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes.

Results: A total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity.

Conclusion: This study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes.

Clinical trial registered with eudract: Number 2018-004967-30.

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探索生物仿制阿达木单抗过渡时期患者观点和有效性的随机交叉试验：IBD参考和生物仿制阿达木单抗交叉研究（iBaSS）。

背景：患者满意度与依从性呈正相关，而依从性有望影响疗效。本研究旨在调查阿达木单抗参照药与生物类似药（SB5）之间转换的临床结果和患者体验。方法：iBaSS 是一项 IV 期单中心、前瞻性、随机、单盲、交叉研究，研究对象为患有克罗恩病的成年患者。在获得同意前已稳定使用阿达木单抗的受试者将接受为期24周的阿达木单抗参考药物和SB5治疗。主要结果是在每个治疗期间保持基线临床状态的患者比例，次要结果是评估患者对疾病控制的看法和治疗满意度：结果：共有 112 名患者入组，他们代表了常规临床实践中遇到的不同患者群体。在每个治疗期间，维持基线临床状态的参与者比例相似：81.8%的患者使用阿达木单抗，79.5%的患者使用SB5。患者报告的结果（IBD-对照问卷（SB5：15.5；参考阿达木单抗15）和TSQM）、不良事件和治疗药物监测在两个治疗期保持一致，但SB5的注射疼痛VAS评分中位数更高（53/100，而参考阿达木单抗为6/100）。研究中进行的转换次数不会影响血清药物浓度或免疫原性：这项研究模拟了现实世界中阿达木单抗的转换，表明进行品牌转换的患者有望获得一致的临床和满意度结果。临床试验在eudract注册：编号2018-004967-30。

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来源期刊

International Journal of Clinical Pharmacy PHARMACOLOGY & PHARMACY-

CiteScore

4.10

自引率

8.30%

发文量

131

审稿时长

4-8 weeks

期刊介绍： The International Journal of Clinical Pharmacy (IJCP) offers a platform for articles on research in Clinical Pharmacy, Pharmaceutical Care and related practice-oriented subjects in the pharmaceutical sciences. IJCP is a bi-monthly, international, peer-reviewed journal that publishes original research data, new ideas and discussions on pharmacotherapy and outcome research, clinical pharmacy, pharmacoepidemiology, pharmacoeconomics, the clinical use of medicines, medical devices and laboratory tests, information on medicines and medical devices information, pharmacy services research, medication management, other clinical aspects of pharmacy. IJCP publishes original Research articles, Review articles , Short research reports, Commentaries, book reviews, and Letters to the Editor. International Journal of Clinical Pharmacy is affiliated with the European Society of Clinical Pharmacy (ESCP). ESCP promotes practice and research in Clinical Pharmacy, especially in Europe. The general aim of the society is to advance education, practice and research in Clinical Pharmacy . Until 2010 the journal was called Pharmacy World & Science.