PMID- 32573307
OWN - NLM
STAT- MEDLINE
DCOM- 20210607
LR  - 20210607
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 36
IP  - 9
DP  - 2020 Sep
TI  - Safety profiles of biologic agents for inflammatory bowel diseases: a prospective 
      pharmacovigilance study in Southern Italy.
PG  - 1457-1463
LID - 10.1080/03007995.2020.1786681 [doi]
AB  - INTRODUCTION: Inflammatory bowel diseases (IBDs) are a public health issue with 
      over 3.5 million patients in Europe, but the advent of several biologic agents 
      has completely changed their management. Pharmacovigilance is needed to early 
      detect expected/unexpected adverse events (AEs) to assess the safety of drugs in 
      a real-world setting. Aim of this prospective pharmacovigilance study was to 
      evaluate the occurrence of AEs in patients treated with biologic drugs in 
      gastroenterology units in Southern Italy. METHODS: All consecutive patients 
      treated with one biologic drug during a 2-years period (2017-2018) in six 
      gastroenterology tertiary units and satisfying inclusion criteria were enrolled. 
      Demographic and clinical characteristics of patients, type of treatment used, 
      therapy discontinuation, failures, switch/swap to another biologic, and possible 
      onset of AEs were collected. Adverse events have been compared to the number of 
      AEs reported in the same centres in the two years before the protocol. RESULTS: 
      Overall, 623 patients (253 females) with Crohn's disease (352; 56.5%) or 
      ulcerative colitis (271; 43.5%) have been included. Infliximab (IFX) was the most 
      commonly used (308, 49.4%), followed by adalimumab (ADA; 215, 34.5%), vedolizumab 
      (VED; 73, 11.7%), golimumab (GOL; 26, 4.2%) and ustekinumab (UST; 0.2%). 
      Ninety-two patients have experienced AEs (14.8%) and 10 serious adverse events 
      (SAEs) (1.6%) were recorded. Adverse events and SAEs have been reported with GOL 
      (7/26; p = .88), IFX (51/308; p = .54), ADA (28/125; p = .40) and VED (6/73; 
      p = .11), no AEs occurred with UST (0/1). CONCLUSION: Overall, considering the 
      low rate of AEs reported and discontinuation from therapy, our data seems to 
      confirm the positive beneficial/risk ratio of biologic treatment for IBDs and 
      provide useful data on biologic drugs in gastroenterology.
FAU - Roberti, Roberta
AU  - Roberti R
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Iannone, Luigi Francesco
AU  - Iannone LF
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Palleria, Caterina
AU  - Palleria C
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - De Sarro, Caterina
AU  - De Sarro C
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Spagnuolo, Rocco
AU  - Spagnuolo R
AUID- ORCID: 0000-0002-0871-4644
AD  - Department of Clinical and Experimental Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Barbieri, Maria Antonietta
AU  - Barbieri MA
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Vero, Ada
AU  - Vero A
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Manti, Antonia
AU  - Manti A
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Pisana, Valentina
AU  - Pisana V
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Fries, Walter
AU  - Fries W
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Trifiro, Gianluca
AU  - Trifiro G
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Naturale, Maria Diana
AU  - Naturale MD
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Larussa, Tiziana
AU  - Larussa T
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - De Francesco, Adele Emanuela
AU  - De Francesco AE
AD  - UOC Pharmacy, "Mater Domini" Hospital, Catanzaro, Italy.
FAU - Bosco, Vincenzo
AU  - Bosco V
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Donato di Paola, Eugenio
AU  - Donato di Paola E
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Citraro, Rita
AU  - Citraro R
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Luzza, Francesco
AU  - Luzza F
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Bennardo, Luigi
AU  - Bennardo L
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Rodino, Stefano
AU  - Rodino S
AD  - Division of Gastroenterology, "Ciaccio-Pugliese" Hospital, Catanzaro, Italy.
FAU - Doldo, Patrizia
AU  - Doldo P
AD  - Department of Clinical and Experimental Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - Spina, Edoardo
AU  - Spina E
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Russo, Emilio
AU  - Russo E
AUID- ORCID: 0000-0002-1279-8123
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
FAU - De Sarro, Giovambattista
AU  - De Sarro G
AD  - Science of Health Department, School of Medicine, University of Catanzaro, 
      Catanzaro, Italy.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200727
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Biological Factors)
SB  - IM
CIN - Curr Med Res Opin. 2020 Oct;36(10):1627-1628. PMID: 32696694
MH  - Adult
MH  - Biological Factors/*adverse effects
MH  - Female
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - *Pharmacovigilance
MH  - Prospective Studies
OTO - NOTNLM
OT  - Adverse events
OT  - biologics
OT  - inflammatory bowel diseases
OT  - pharmacovigilance
EDAT- 2020/06/24 06:00
MHDA- 2021/06/08 06:00
CRDT- 2020/06/24 06:00
PHST- 2020/06/24 06:00 [pubmed]
PHST- 2021/06/08 06:00 [medline]
PHST- 2020/06/24 06:00 [entrez]
AID - 10.1080/03007995.2020.1786681 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2020 Sep;36(9):1457-1463. doi: 10.1080/03007995.2020.1786681. 
      Epub 2020 Jul 27.