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Review
. 2022 Jul 29;11(15):4422.
doi: 10.3390/jcm11154422.

Safety of Biological Therapies in Elderly Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Gustavo Drügg Hahn  1   2 , Petra Anna Golovics  1   3 , Panu Wetwittayakhlang  1   4 , Dirlene Melo Santa Maria  2 , Usiara Britto  2 , Gary Edward Wild  1 , Waqqas Afif  1 , Alain Bitton  1 , Talat Bessissow  1 , Peter Laszlo Lakatos  1   5
Affiliations
Review

Safety of Biological Therapies in Elderly Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Gustavo Drügg Hahn et al. J Clin Med. .

Abstract

Background and Aim: Newer biologics appeared safer in landmark clinical trials, but their safety is understudied in vulnerable populations. The aim of the present study was to perform a systematic review and meta-analysis to assess the safety of available biologicals in the elderly IBD population. Methods: We systematically searched PubMed/Medline and conference proceedings between 1 April 1969 and 1 June 2021 to identify eligible studies that examined the safety of biologics in elderly patients with IBD. Of the 2885 articles and 12 congress abstracts identified, 12 peer reviewed papers and 3 abstracts were included after independent evaluation by two reviewers. The identified studies collected safety data on anti-TNF, vedolizumab (VDZ) and ustekinumab (UST). Results: Rates of AE and infections were not different among the biologics (AE mean rate: 11.3 (CI 95% 9.9-12.7)/100 pts-years; p = 0.11, infection mean rate: 9.5 (CI 95% 8.4-10.6)/100 pts-years; p = 0.56) in elderly IBD patients on anti-TNF, VDZ or UST. Infusion/injection reaction rates were more common on anti-TNFs (mean rate: 2.51 (CI 95% 1.7-3.4/100 pts-years; p = 0.02). and malignancy rates were higher on VDZ/UST (mean rate: 2.14 (CI 95% 1.6-2.8)/100 pts-years; p = 0.01). Conclusions: Rates of AEs and infections were not different among biologicals. Infusion/injection reactions were more common on anti-TNFs. Current data are insufficient to suggest the sequencing of biologicals in elderly patients based on safety.

Keywords: biologics; elderly; inflammatory bowel disease; safety.

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Conflict of interest statement

G.D.H. declares no conflict of interest. P.A.G. has been a speaker for AbbVie, Takeda, Fresenius and Ferring. P.W. has been a speaker and/or advisory board member for Takeda, Pfizer, Janssen, Ferring, A. Menerini and MSD. D.M.S.M. declares no conflict of interest. U.B. declares no conflict of interest. G.W. declares no conflict of interest. T.B. has been a speaker or advisory board member for Takeda, Janssen, Abbvie, Merck, Pfizer, Pendopharm, Ferring, Shire, Sandoz, BMS and Roche. W.A. has been a speaker for Janssen, Prometheus, Dynacare, Takeda, AbbVie and Theradiag. A.B. has been a member of advisory boards for Abbvie, Pfizer, Takeda, Janssen and Merck and a speaker for Abbvie, Janssen, Takeda and Pfizer. P.L.L. has been a speaker and/or advisory board member for AbbVie, Arena, Falk Pharma GmbH, Ferring, Genetech, Janssen, Kyowa Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, MSD, Pfizer, Roche, Shire, Takeda and Tillots and has received unrestricted research grants from AbbVie, MSD and Pfizer.

Figures

Figure 1
Figure 1
Flow chart of study selection.
Figure 2
Figure 2
Rates of adverse events (AE). Mean rates per 100 patient years (PY).
Figure 3
Figure 3
Rates of infection. Mean rates per 100 patient years (PY).
Figure 4
Figure 4
Rates of infusion/injection reaction. Mean rates per 100 patient years (PY).
Figure 5
Figure 5
Malignancy rates. Mean rates per 100 patient years (PY).
See this image and copyright information in PMC

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