The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease,BioDrugs

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The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease
BioDrugs ( IF 5.4 ) Pub Date : 2022-08-12 , DOI: 10.1007/s40259-022-00548-4
Krishneel Dutt ₁ , Ashish Srinivasan _{1,

2} , Daniel Van Langenberg _{1,

2}

Affiliation

Background

Despite growing awareness of the nocebo effect, few studies have evaluated the nocebo effect using combined assessment of patient-reported outcome measures (PROMs), clinical indices, and objective biomarkers in inflammatory bowel disease (IBD) patients switching from originator to biosimilar medicines.

Objective

This study aimed to compare these outcomes across switch and non-switch cohorts to evaluate the nocebo effect in patients with IBD.

Methods

Parallel cohorts of IBD patients who (1) switched from originator to biosimilar (CT-P13) infliximab and (2) continued biosimilar (CT-P13) infliximab were evaluated over 32 weeks. Clinical disease activity, objective biomarkers and PROMs were assessed at baseline, and weeks 16 and 32 across both cohorts. The PROM of interest was patient-perceived disease activity evaluated using a 0–100 visual analogue scale (VAS) per the IBD-Control Questionnaire.

Results

Of 81 patients, 47 switched from originator to biosimilar (CT-P13) infliximab. A negative change from baseline patient-reported disease control was observed across the switch cohort compared with the non-switch cohort at week 16 (mean VAS − 8.21 vs. 1.26; p = 0.03), but not at week 32 (mean VAS − 1.21 vs. 1.38; p = 0.58). Corresponding clinical and objective biomarker assessments over these timepoints were comparable across both cohorts.

Conclusion

This study demonstrated a temporary yet discernible nocebo effect in the first 16 weeks following non-medical switching that was not sustained at week 32. Negative patient perceptions may be overcome by a patient-inclusive approach to non-medical switching in conjunction with close clinical follow-up and disease monitoring.

中文翻译：

在炎症性肠病中从原研药到生物仿制药英夫利昔单抗的非医疗转换项目中的反安慰剂效应

背景

尽管对反安慰剂效应的认识日益提高，但很少有研究通过综合评估患者报告的结果测量 (PROM)、临床指标和炎症性肠病 (IBD) 患者从原研药转向生物仿制药的客观生物标志物来评估反安慰剂效应。

客观的

本研究旨在比较转换和非转换队列的这些结果，以评估 IBD 患者的反安慰剂效应。

方法

在 32 周内评估了 (1) 从原研药转为生物仿制药 (CT-P13) 英夫利昔单抗和 (2) 继续使用生物仿制药 (CT-P13) 英夫利昔单抗的 IBD 患者的平行队列。在基线以及两个队列的第 16 周和第 32 周评估临床疾病活动、客观生物标志物和 PROM。感兴趣的 PROM 是根据 IBD 对照问卷使用 0-100 视觉模拟量表 (VAS) 评估的患者感知的疾病活动。

结果

在 81 名患者中，47 名从原研药转为生物仿制药 (CT-P13) 英夫利昔单抗。在第 16 周（平均 VAS - 8.21 对 1.26； p = 0.03），在转换队列与非转换队列相比，观察到从基线患者报告的疾病控制的负变化，但在第 32 周没有（平均 VAS - 1.21与 1.38；p = 0.58）。在这些时间点上相应的临床和客观生物标志物评估在两个队列中具有可比性。