Rabbitt Louise, Keogh Áine, Duane Linda, Ferguson John, Hobbins Anna, McGuire Brian E, Gillespie Patrick, Egan Laurence J
Discipline of Pharmacology and Therapeutics, School of Medicine, University of Galway, Ireland.
Department of Gastroenterology, Galway University Hospitals, Galway, Ireland.
Br J Clin Pharmacol. 2025 Sep;91(9):2628-2635. doi: 10.1002/bcp.70086. Epub 2025 Apr 29.
Amgevita is a licensed biosimilar to adalimumab, having demonstrated high pharmacokinetic and clinical similarity to Humira. Switching to a lower-cost medicine may elicit a nocebo effect, whereby expectations of poorer efficacy impact outcomes despite pharmacological similarity. This prospective cohort study examined clinical and economic outcomes and associated psychosocial variables in a group of patients undergoing a nonmedical switch to biosimilar adalimumab.
Patients with inflammatory bowel disease (IBD) were followed before and after switching from Humira to Amgevita. Objective disease activity was assessed pre- and post-switch using the Harvey-Bradshaw Index (Crohn's disease) or partial Mayo score (ulcerative colitis), faecal calprotectin and C-reactive protein. Subjective symptom burden was measured using the IBD Control Questionnaire (IBDCQ). Pre-switch, health anxiety was measured using the Health Anxiety Index (HAI).
In total, 64 patients aged 18-67 were enrolled. IBDCQ scores marginally improved post-switch (13.33 vs, 12.49, P = .043), with no significant changes in objective disease activity scores, faecal calprotectin or C-reactive protein. Sixteen patients reported 17 new adverse events within 4 weeks. Logistic regression revealed a significant relationship between HAI scores and adverse events (P = .0079); each unit increase in HAI score increased the odds of reporting an adverse event by 21%. Drug cost savings for the 64 patients over 8 weeks totalled €143 958.
Switching to biosimilar adalimumab did not affect disease control or quality of life. 25% of patients developed new side effects, particularly those with high levels of health anxiety. Significant cost savings were achieved.
Amgevita是一种已获许可的阿达木单抗生物类似药，已证明其与修美乐具有高度的药代动力学和临床相似性。改用低成本药物可能会引发反安慰剂效应，即尽管药物相似，但对疗效较差的预期会影响治疗结果。这项前瞻性队列研究调查了一组改用生物类似药阿达木单抗的患者的临床和经济结果以及相关的社会心理变量。
对炎症性肠病（IBD）患者从修美乐改用Amgevita前后进行随访。使用哈维-布拉德肖指数（克罗恩病）或部分梅奥评分（溃疡性结肠炎）、粪便钙卫蛋白和C反应蛋白在换药前后评估客观疾病活动度。使用IBD控制问卷（IBDCQ）测量主观症状负担。换药前，使用健康焦虑指数（HAI）测量健康焦虑。
总共招募了64名年龄在18至67岁之间的患者。换药后IBDCQ评分略有改善（13.33对12.49，P = 0.043），客观疾病活动度评分、粪便钙卫蛋白或C反应蛋白无显著变化。16名患者在4周内报告了17起新的不良事件。逻辑回归显示HAI评分与不良事件之间存在显著关系（P = 0.0079）；HAI评分每增加一个单位，报告不良事件的几率增加21%。64名患者在8周内节省的药物费用总计143958欧元。
改用生物类似药阿达木单抗不影响疾病控制或生活质量。25%的患者出现了新的副作用，尤其是那些健康焦虑水平较高的患者。实现了显著的成本节约。
