Cantini Fabrizio, Niccoli Laura, Franchi Giulia, Damiani Arianna, Benucci Maurizio
Department of Rheumatology, Hospital of Prato, Azienda USL Toscana Centro, Italy.
Rheumatology Unit, San Giovanni di Dio Hospital, Azienda USL Toscana Centro, Florence, Italy.
Isr Med Assoc J. 2020 Mar;22(3):185-190.
We describe the features of nocebo, and its impact in studies of transition from the originator to the respective biosimilar in inflammatory rheumatic diseases. Investigations in healthy volunteers as well as in the neurology and anesthesiology fields demonstrated the involved cerebral areas and the neurotransmitter pathways responsible for the nocebo response. Whether these findings are applicable to patients with inflammatory rheumatic diseases remains to be demonstrated. Nocebo may account for part of the after-switching biosimilar failures. However, in the absence of validated classification or diagnostic criteria, specific neurochemical and neuroimaging studies, the lack of data on serum tumor necrosis factor and drug levels, and the disease improvement after the switching back to the originator biologic observed in some patients, the nocebo diagnosis remains the role of the individual clinician. Investigations on nocebo pathophysiology and diagnosis are required to address its impact in after-transition biosimilar studies in rheumatology.
我们描述了反安慰剂效应的特征，及其在炎性风湿性疾病中从原研药向相应生物类似药转换研究中的影响。对健康志愿者以及神经学和麻醉学领域的研究表明了涉及反安慰剂反应的脑区和神经递质途径。这些发现是否适用于炎性风湿性疾病患者仍有待证实。反安慰剂效应可能是部分生物类似药转换后疗效不佳的原因。然而，由于缺乏经过验证的分类或诊断标准、特定的神经化学和神经影像学研究、血清肿瘤坏死因子和药物水平的数据，以及在一些患者中观察到换回原研生物制剂后疾病改善的情况，反安慰剂效应的诊断仍然取决于临床医生个人。需要对反安慰剂效应的病理生理学和诊断进行研究，以探讨其在风湿病生物类似药转换后研究中的影响。
