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. 2022 Jan;20(1):114-123.
doi: 10.5217/ir.2021.00037. Epub 2021 Aug 4.

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation

Brigida Barberio  1 , Edoardo Vincenzo Savarino  1 , Timothy Card  2   3   4 , Cristina Canova  5 , Francesco Baldisser  1 , Alessandro Gubbiotti  1 , Davide Massimi  1 , Matteo Ghisa  1 , Fabiana Zingone  1
Affiliations

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation

Brigida Barberio et al. Intest Res. 2022 Jan.

Abstract

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.

Keywords: Adalimumab; Adverse events; Biological therapy; Inflammatory bowel disease; Vedolizumab.

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Conflict of interest statement

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.

Figures

Fig. 1.
Fig. 1.
Kaplan-Meier of adverse events which caused withdrawal of therapy in adalimumab (ADA) patients and in vedolizumab (VDZ) patients during the study period.
Fig. 2.
Fig. 2.
Kaplan-Meier of adverse events which did not cause withdrawal of therapy in adalimumab (ADA) patients and in vedolizumab (VDZ) patients in the first year of treatment.
See this image and copyright information in PMC

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