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多学科团队干预以减少从原研英夫利昔单抗转换为生物类似药时的类效应。

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar.

机构信息

Rheumatology, Hopital Saint-Antoine, Sorbonne University, Paris, France

Pharmacy, Hopital Saint-Antoine, Paris, France.

出版信息

RMD Open. 2021 Jan;7(1). doi: 10.1136/rmdopen-2020-001396.

Abstract

OBJECTIVES

To evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).

METHODS

An intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.

RESULTS

45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.

CONCLUSIONS

A tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

摘要

目的

评估在慢性炎症性风湿病(CIRD)患者中从原研英夫利昔单抗(OI)转换为英夫利昔单抗生物类似药 SB2 时,减少类效应(NE)的干预措施。

方法

根据系统评价干预措施减少肌肉骨骼疾病中的 NE 和对半定向询问 5 名患者的结果,与医疗保健专业人员(HPs)和一名患者代表一起构建干预措施。我们的策略包括培训 HPs、由护士提供的转换信息和一致的词汇。所有从 OI 转换为 SB2 的 CIRD 患者均纳入干预组。主要结局为 34 周时的 SB2 保留率(RR)。次要结局为 12 个月时的 SB2 RR、因可能的 NE 而停药的比例,以及与接受 OI 的 CIRD 患者的历史队列和 6 个已发表的欧洲队列进行比较。

结果

2018 年 3 月纳入了 45 名患者(类风湿关节炎,n=17;脊柱关节炎,n=28)。34 周时,SB2 RR 为 91.2%,与历史队列 RR 相似(p=0.41),但高于 3 个欧洲队列的 RR(p<0.05)。12 个月时,SB2 RR 为 84.5%,与历史队列 RR 相似(p=0.52)。因可能的 NE 而停药的比例为 12 个月时的 6.6%。

结论

与已发表的结果相比,护士在非医疗转换中发挥突出作用的定制沟通可降低从 OI 转换为 SB2 时的 NE。RR 与历史队列 RR 相似。用于构建这种干预措施的方法可能有助于改善即将到来的生物类似药转换的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2dc4/7839879/81b21035628d/rmdopen-2020-001396f01.jpg

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