PMID- 36432640 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221213 IS - 1999-4923 (Print) IS - 1999-4923 (Electronic) IS - 1999-4923 (Linking) VI - 14 IP - 11 DP - 2022 Nov 13 TI - Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study. LID - 10.3390/pharmaceutics14112449 [doi] LID - 2449 AB - BACKGROUND: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are fundamental to early recognize expected and unexpected adverse events (AEs), representing a powerful tool to better determine the safety profiles of biologics in a real-world setting. METHODS: This study aimed to identify the occurrence of AEs and therapeutic failures linked to biological drugs used in gastroenterology units during a prospective pharmacovigilance program in Southern Italy. Patients affected by IBDs and treated with a biologic agent, from 1 January 2019, to 31 December 2021 (study period) in three gastroenterology units were enrolled. RESULTS: Overall, 358 patients with a diagnosis of active Crohn's disease or ulcerative colitis satisfying inclusion criteria have been enrolled. Infliximab (IFX) was the most administered drug at the index date (214; 59.8%), followed by Adalimumab (ADA; 89; 24.9%), Golimumab (GOL; 37; 10.3%), Vedolizumab (VDZ; 17; 4.7%) and Ustekimumab (UST; 1; 0.3%). Seventy-three patients (20.4%) experienced at least one AE, while 62 patients (17.3%) had therapeutic ineffectiveness. No serious AEs were reported in the follow-up period in the enrolled patients. AEs have been described with IFX (50/214; p = 0.47), GOL (7/37; p = 0.78), ADA (13/89; p = 0.18), and VDZ (3/17; p = 0.52), no AEs have been noticed with UST (0/1). CONCLUSIONS: Based on the low rate of AEs observed and withdrawal from treatment, our data seem to corroborate the favorable beneficial/risk profile of biologics for IBDs. FAU - Tallarico, Martina AU - Tallarico M AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - Palleria, Caterina AU - Palleria C AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - Ruffolo, Livia AU - Ruffolo L AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - Spagnuolo, Rocco AU - Spagnuolo R AUID- ORCID: 0000-0002-0871-4644 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - Naturale, Maria Diana AU - Naturale MD AUID- ORCID: 0000-0002-5599-1265 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - De Francesco, Adele Emanuela AU - De Francesco AE AD - UOC Pharmacy, "Mater Domini" Hospital, 88100 Catanzaro, Italy. FAU - De Sarro, Caterina AU - De Sarro C AUID- ORCID: 0000-0002-3596-0090 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - Romeo, Rossella AU - Romeo R AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - Citraro, Rita AU - Citraro R AUID- ORCID: 0000-0001-6746-6751 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - Doldo, Patrizia AU - Doldo P AD - Department of Experimental and Clinical Medicine, Magna Graecia University, 88100 Catanzaro, Italy. FAU - Abenavoli, Ludovico AU - Abenavoli L AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. FAU - Gallelli, Luca AU - Gallelli L AUID- ORCID: 0000-0003-0858-7902 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - Luzza, Francesco AU - Luzza F AUID- ORCID: 0000-0001-5120-1046 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - Leo, Antonio AU - Leo A AUID- ORCID: 0000-0002-0061-1608 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. FAU - De Sarro, Giovambattista AU - De Sarro G AUID- ORCID: 0000-0002-7629-6579 AD - Department of Health Sciences, Magna Graecia University of Catanzaro, Calabria, 88100 Catanzaro, Italy. AD - System and Applied Pharmacology@University Magna Grecia (FAS@UMG) Research Center, Science of Health Department, School of Medicine, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy. LA - eng GR - GR-2016-02364307/Ministero della Salute/ GR - AIFA/Italian Medicines Agency/ PT - Journal Article DEP - 20221113 PL - Switzerland TA - Pharmaceutics JT - Pharmaceutics JID - 101534003 PMC - PMC9696291 OTO - NOTNLM OT - biologics OT - inflammatory bowel diseases OT - post-marketing surveillance COIS- The authors declare that they have no potential conflict of interest that might be relevant to the content of this article. EDAT- 2022/11/27 06:00 MHDA- 2022/11/27 06:01 PMCR- 2022/11/13 CRDT- 2022/11/26 01:31 PHST- 2022/10/14 00:00 [received] PHST- 2022/11/05 00:00 [revised] PHST- 2022/11/11 00:00 [accepted] PHST- 2022/11/26 01:31 [entrez] PHST- 2022/11/27 06:00 [pubmed] PHST- 2022/11/27 06:01 [medline] PHST- 2022/11/13 00:00 [pmc-release] AID - pharmaceutics14112449 [pii] AID - pharmaceutics-14-02449 [pii] AID - 10.3390/pharmaceutics14112449 [doi] PST - epublish SO - Pharmaceutics. 2022 Nov 13;14(11):2449. doi: 10.3390/pharmaceutics14112449.