ABSTRACT
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.