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. 2023 Oct 3;13(10):e073071.
doi: 10.1136/bmjopen-2023-073071.

Comparing persistence of new biologics to conventional anti-TNF alphas in adult patients with inflammatory bowel disease: a systematic review and meta-analysis protocol

Tsz Hong Yiu  1 , Yanna Ko  2   3 , Aviv Pudipeddi  3 , Patrizia Natale  4   5   6 , Rupert W Leong  3
Affiliations

Comparing persistence of new biologics to conventional anti-TNF alphas in adult patients with inflammatory bowel disease: a systematic review and meta-analysis protocol

Tsz Hong Yiu et al. BMJ Open. .

Abstract

Background: Biological therapy is a cornerstone of managing moderate-to-severe inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD). New biologics have been evolving over the past 20 years and selection of an agent remains challenging.Drug persistence measures the duration of time from initiation to discontinuation of a therapy, which can be a surrogate marker of drug tolerance and efficacy.

Objectives: The study aimed to compare drug persistence of new generation biologics for the treatment of UC and CD (vedolizumab, ustekinumab, certolizumab, tofacitinib, natalizumab and golimumab) with conventional anti-tumor necroisis factor alphas (anti-TNF alphas) (adalimumab and infliximab) in adult patients with IBD. Results of the study may provide guidance on the preferred first and subsequent lines of biological treatments in patients with IBD.

Methods and analysis: Search via electronic databases including EMBASE, MEDLINE, PubMed and clinical trial databases will be conducted on 10 March 2023 with eligible studies included from inception of 2017 to 2023. The primary outcomes are 1-year persistence of individual biologics with comparison of new biologics versus conventional anti-TNF alphas. A meta-analysis will be conducted using Review Manager V.5 and outcome will be presented as relative risk. Heterogeneity will be assessed with forest plot, χ2 and I2, followed with sensitivity analysis and subgroup analysis. Finally, the Grading of Recommendations Assessment, Development and Evaluation system will be used to assess the quality of evidence.

Ethics and dissemination: Ethical approval is not required as no private information of participants will be used. Results of the present study will be disseminated in a peer-reviewed journal or conference presentation.

Prospero registration number: CRD42023392236.

Keywords: adult gastroenterology; clinical pharmacology; inflammatory bowel disease; therapeutics.

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Conflict of interest statement

Competing interests: RWL is an advisory board member of AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grant recipient of Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer and Joanna Tiddy grants University of Sydney. AP is an advisory board member of AbbVie and received speaker fees from AbbVie and Takeda.

Figures

Figure 1
Figure 1
Flow diagram of the study selection process.
See this image and copyright information in PMC

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