D'Onofrio Antonio M, Balzoni Lodovico M, Ferrajoli Gaspare F, DI Vincenzo Federica, Napolitano Daniele, Schiavoni Elisa, Kotzalidis Georgios D, Simonetti Alessio, Mazza Marianna, Rosa Ilenia, Pettorruso Mauro, Sani Gabriele, Gasbarrini Antonio, Scaldaferri Franco, Camardese Giovanni
Section of Psychiatry, Department of Neuroscience, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy -
Section of Psychiatry, Department of Neuroscience, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.
Minerva Gastroenterol (Torino). 2025 Mar;71(1):22-32. doi: 10.23736/S2724-5985.24.03719-7. Epub 2024 Sep 18.
Biological agents were found to alter the psychopathological profile of a small subgroup of patients treated for a variety of conditions, including inflammatory bowel disease (IBD) and psychiatric disorders. The association between the administration of biological agents and psychopathology needs to be further investigated.
In this naturalistic prospective cohort study, patients with IBD were assigned to two treatment groups, i.e., a biological agent (which also included tofacitinib) or conventional therapy. Clinician-administered scales were used to assess psychosomatic symptoms (Hamilton Depression Rating Scale [Ham-D], Hamilton Anxiety Rating Scale [Ham-A], Young Mania Rating Scale [YMRS], and Brief Psychiatric Rating Scale [BPRS]) and disease activity (Mayo Score and Harvey-Bradshaw Index [HBI]) at baseline, after one, three, and six months of treatment. Each group was assessed for the course of their scores during the observation period at each assessment point.
Patients on biological drugs who completed three months of treatment (N.=32) and six months of treatment (N.=20) scored significantly lower on the Mayo compared to baseline. Patients on conventional treatment obtained significant drops from baseline on the HBI after one and three months of treatment (N.=30) and also at the six-month endpoint (N.=11). Both groups showed no improvement or worsening on the psychiatric rating scales.
In this study, we found no evidence of psychiatric symptom worsening, as some literature would suggest. Our data suggest that the use of biological agents in IBD is safe.
生物制剂被发现可改变一小部分接受各种疾病治疗的患者的精神病理学特征，这些疾病包括炎症性肠病（IBD）和精神障碍。生物制剂的使用与精神病理学之间的关联需要进一步研究。
在这项自然前瞻性队列研究中，IBD患者被分为两个治疗组，即生物制剂组（其中也包括托法替布）和传统治疗组。在基线、治疗1个月、3个月和6个月后，使用临床医生评定量表评估心身症状（汉密尔顿抑郁评定量表[Ham-D]、汉密尔顿焦虑评定量表[Ham-A]、杨氏躁狂评定量表[YMRS]和简明精神病评定量表[BPRS]）和疾病活动度（梅奥评分和哈维-布拉德肖指数[HBI]）。在每个评估点，对每组在观察期内的评分过程进行评估。
完成3个月治疗的生物制剂组患者（N = 32）和完成6个月治疗的患者（N = 20），其梅奥评分相比基线显著降低。接受传统治疗的患者在治疗1个月和3个月后（N = 30）以及6个月终点时（N = 11），HBI较基线有显著下降。两组在精神病评定量表上均未显示改善或恶化。
在本研究中，我们没有发现如一些文献所提示的精神症状恶化的证据。我们的数据表明，IBD患者使用生物制剂是安全的。
