PMID- 34333908
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220223
IS  - 1598-9100 (Print)
IS  - 2288-1956 (Electronic)
IS  - 1598-9100 (Linking)
VI  - 20
IP  - 1
DP  - 2022 Jan
TI  - Incidence comparison of adverse events in patients with inflammatory bowel 
      disease receiving different biologic agents: retrospective long-term evaluation.
PG  - 114-123
LID - 10.5217/ir.2021.00037 [doi]
AB  - BACKGROUND/AIMS: Current literature is lacking in studies comparing the incidence 
      of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) 
      treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. 
      Therefore, our primary aim was to compare the AEs occurring in patients taking 
      ADA to those of patients taking VDZ. METHODS: In this single center study, data 
      on AEs from IBD patients who underwent treatment with ADA and VDZ were 
      retrospectively collected. AE rates per 100 person-years were calculated. A Cox 
      regression model was used to estimate the hazard ratios of the AEs between the 2 
      drugs. RESULTS: A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had 
      AEs causing drug interruption during the study period (P=0.02). Most of the AEs 
      were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while 
      infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% 
      in those treated with VDZ. The incidence rate of AEs causing withdrawal of 
      therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for 
      VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first 
      year of treatment, we observed 34 subjects treated with ADA (36.5%) having at 
      least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67). CONCLUSIONS: VDZ has 
      a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but 
      a similar risk of AEs not causing drug interruption. Real-life head-to-head 
      studies are still necessary to further explore the safety profile of these drugs.
FAU - Barberio, Brigida
AU  - Barberio B
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Savarino, Edoardo Vincenzo
AU  - Savarino EV
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Card, Timothy
AU  - Card T
AD  - NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS 
      Trust and University of Nottingham, Nottingham, UK.
AD  - Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.
AD  - Division of Epidemiology and Public Health, School of Medicine, University of 
      Nottingham, Nottingham, UK.
FAU - Canova, Cristina
AU  - Canova C
AD  - Department of Cardio-Thoraco-Vascular Sciences and Public Health, University of 
      Padua, Padua, Italy.
FAU - Baldisser, Francesco
AU  - Baldisser F
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Gubbiotti, Alessandro
AU  - Gubbiotti A
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Massimi, Davide
AU  - Massimi D
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Ghisa, Matteo
AU  - Ghisa M
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
FAU - Zingone, Fabiana
AU  - Zingone F
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology (DISCOG), University of Padua, Padua, Italy.
LA  - eng
PT  - Journal Article
DEP - 20210804
PL  - Korea (South)
TA  - Intest Res
JT  - Intestinal research
JID - 101572802
PMC - PMC8831779
OTO - NOTNLM
OT  - Adalimumab
OT  - Adverse events
OT  - Biological therapy
OT  - Inflammatory bowel disease
OT  - Vedolizumab
COIS- Conflict of Interest Savarino EV has received lecture or consultancy fees from 
      Takeda, Merck & Co, Bristol-Myers Squibb, AbbVie, Amgen, Novartis, Fresenius 
      Kabi, Sandoz, Sofar, Janssen. Card T was previously married to a subsequent 
      employee of Takeda. Zingone F has received lecture fees from Takeda, Janssen, 
      Norgine. The other authors declare that they have no conflicting interests.
EDAT- 2021/08/03 06:00
MHDA- 2021/08/03 06:01
PMCR- 2022/01/01
CRDT- 2021/08/02 01:46
PHST- 2021/02/27 00:00 [received]
PHST- 2021/06/16 00:00 [accepted]
PHST- 2021/08/03 06:00 [pubmed]
PHST- 2021/08/03 06:01 [medline]
PHST- 2021/08/02 01:46 [entrez]
PHST- 2022/01/01 00:00 [pmc-release]
AID - ir.2021.00037 [pii]
AID - ir-2021-00037 [pii]
AID - 10.5217/ir.2021.00037 [doi]
PST - ppublish
SO  - Intest Res. 2022 Jan;20(1):114-123. doi: 10.5217/ir.2021.00037. Epub 2021 Aug 4.