Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study

doi:10.3748/wjg.v28.i33.4823

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World Journal of Gastroenterology

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Retrospective Cohort Study

World J Gastroenterol. Sep 7, 2022; 28(33): 4823-4833
Published online Sep 7, 2022. doi: 10.3748/wjg.v28.i33.4823

Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study

Gustavo Drügg Hahn, Jean-Frédéric LeBlanc, Petra Anna Golovics, Panu Wetwittayakhlang, Abdulrahman Qatomah, Anna Wang, Levon Boodaghians, Jeremy Liu Chen Kiow, Maryam Al Ali, Gary Wild, Waqqas Afif, Alain Bitton, Peter Laszlo Lakatos, Talat Bessissow

Gustavo Drügg Hahn, Petra Anna Golovics, Panu Wetwittayakhlang, Abdulrahman Qatomah, Anna Wang, Levon Boodaghians, Maryam Al Ali, Gary Wild, Waqqas Afif, Alain Bitton, Peter Laszlo Lakatos, Talat Bessissow, Division of Gastroenterology, IBD Center, McGill University Health Center, Montreal H3G 1A4, Quebec, Canada

Gustavo Drügg Hahn, School of Medicine, Graduate Course Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre 90000-000, Brazil

Jean-Frédéric LeBlanc, Division of Gastroenterology, McGill University Health Centre, Montreal H3G 1A4, Quebec, Canada

Petra Anna Golovics, Department of Gastroenterology, Hungarian Defense Forces, Medical Centre, Budapest 1134, Hungary

Panu Wetwittayakhlang, Unit of Gastroenterology and Hepatology, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand

Jeremy Liu Chen Kiow, Department of Gastroenterology, Centre Hospitalier de l’Université de Montréal, Montreal H2X 3E4, Quebec, Canada

Author contributions: Hahn GD and Bessissow T are guarantors of the manuscript; LeBlanc JF and Bessissow T designed the study; LeBlanc JF, Qatomah A, Wang A, Boodaghians L, Liu Chen Kiow J and Al Ali M performed the data collection; Drügg Hahn G, LeBlanc JF, Golovics PA, Wetwittayakhlang P, Lakatos PL and Bessissow T performed the data interpretation; Lakatos PL performed the statistical analysis; Drügg Hahn G wrote the initial draft of the manuscript, and Golovics PA, Wetwittayakhlang P, Wild G, Afif W, Bitton A, Lakatos PL and Bessissow T were involved in the critical revision of the manuscript; and all the authors reviewed and approved the final manuscript.

Institutional review board statement: The study was approved by the Research Ethics Board of McGill University Health care center, Montreal, Quebec, Canada, under protocol No. 2019-5209. Individual patient-level data were de-identified to maintain confidentiality in all steps of study analysis. This study was conducted in compliance with regulations stated in the 1975 Declaration of Helsinki.

Informed consent statement: Informed consent was obtained from each patient included in the study.

Conflict-of-interest statement: Hahn GD, Qatomah A, Wang A, Boodaghians L, Liu Chen Kiow J, Al Ali M, and Wild G declared no conflict of interest; LeBlanc JF has been a speaker or advisory board member for Janssen and Takeda; Golovics PA has been a speaker for AbbVie, Takeda, Fresenius, Ferring; Wetwittayakhlang P has been a speaker and/or advisory board member: Takeda, Pfizer, Janssen, Ferring, A. Menerini, and MSD; Afif W has been a speaker for Janssen, Prometheus, Dynacare, Takeda, AbbVie Theradiag; Bitton A has been a member of Advisory Boards - Abbvie, Pfizer, Takeda, Janssen, Merck; Speaker’s bureau - Abbvie, Janssen, Takeda, Pfizer; Lakatos PL 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; Bessissow T has been a speaker or advisory board member for Takeda, Janssen, Abbvie, Merck, Pfizer, Pendopharm, Ferring, Shire, Sandoz, BMS, Roche, Fresenius Kabi, Viatris.

Data sharing statement: The main data are given in this article. The data are available from the corresponding author upon request.

STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.

Corresponding author: Peter Laszlo Lakatos, AGAF, DSc, FEBG, MD, PhD, Chief Physician, Professor, Division of Gastroenterology, IBD Center, McGill University Health Center, 1650 Ave. Cedar, D7.211, Montreal H3G 1A4, Quebec, Canada. kislakpet99@gmail.com

Received: January 28, 2022
Peer-review started: January 28, 2022
First decision: March 11, 2022
Revised: March 17, 2022
Accepted: August 14, 2022
Article in press: August 14, 2022
Published online: September 7, 2022
Processing time: 214 Days and 14.3 Hours

Abstract

BACKGROUND

Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease (IBD) however data on the efficacy and side effects of these therapies in the elderly is scant.

AIM

To evaluate retrospectively the drug sustainability, effectiveness, and safety of the biologic therapies in the elderly IBD population.

METHODS

Consecutive elderly (≥ 60 years old) IBD patients, treated with biologics [infliximab (IFX), adalimumab (ADAL), vedolizumab (VDZ), ustekinumab (UST)] followed at the McGill University Inflammatory Bowel Diseases Center were included between January 2000 and 2020. Efficacy was measured by clinical scores at 3, 6-9 and 12-18 mo after initiation of the biologic therapy. Patients completing induction therapy were included. Adverse events (AEs) or serious AE were collected during and within three months of stopping of the biologic therapy.

RESULTS

We identified a total of 147 elderly patients with IBD treated with biologicals during the study period, including 109 with Crohn’s disease and 38 with ulcerative colitis. Patients received the following biologicals: IFX (28.5%), ADAL (38.7%), VDZ (15.6%), UST (17%). The mean duration of biologic treatment was 157.5 (SD = 148) wk. Parallel steroid therapy was given in 34% at baseline, 19% at 3 mo, 16.3% at 6-9 mo and 6.5% at 12-18 mo. The remission rates at 3, 6-9 and 12-18 mo were not significantly different among biological therapies. Kaplan-Meyer analysis did not show statistical difference for drug sustainability (P = 0.195), time to adverse event (P = 0.158) or infection rates (P = 0.973) between the four biologics studied. The most common AEs that led to drug discontinuation were loss of response, infusion/injection reaction and infection.

CONCLUSION

Current biologics were not different regarding drug sustainability, effectiveness, and safety in the elderly IBD population. Therefore, we are not able to suggest a preferred sequencing order among biologicals.

Keywords: Inflammatory bowel disease; Biologics; Elderly; Efficacy; Safety; Adverse events

Core Tip: Data on the efficacy and side effects of biologic therapies in the elderly inflammatory bowel disease (IBD) population is scant. Our single center study evaluates retrospectively the drug sustainability, effectiveness, and safety of approved biologic therapies in this sensitive population. The major finding of our study was that the drug sustainability and safety of the different biologicals were not significantly different in a large real-world, elderly IBD cohort treated in this single tertiary IBD center. As a consequence, we are still not able to suggest a preferred sequencing order among biologicals.