Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Sailish Honap; Susanna Meade; Hajir Ibraheim; Peter M. Irving; Michael P. Jones; Mark A. Samaan

doi:10.1007/s10620-021-06932-4

Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Sailish Honap^*, Susanna Meade, Hajir Ibraheim, Peter M. Irving, Michael P. Jones, Mark A. Samaan

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

57 Citations (Scopus)

Abstract

Introduction: Ustekinumab, an interleukin-12 and interleukin-23 antagonist, is licensed for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) after the phase III trial programs demonstrated efficacy over placebo. However, these findings may not be directly transferable to the real-world due to the stringent inclusion criteria of clinical trials. Methods: We conducted a systematic review and meta-analysis of the safety and effectiveness of ustekinumab in inflammatory bowel disease (IBD). A systematic literature search was conducted via Medline and Embase from inception to April 21, 2020. Observational studies assessing ustekinumab’s safety and effectiveness by reporting response, remission and/or adverse events (AE) in either CD or UC were included. Two reviewers independently assessed risk of bias and extracted study data. Random-effects meta-analysis was performed to pool rates of clinical response, remission, and safety data. Results: Following deduplication, 2147 records were identified of which 41 studies (38 CD, 3 UC) comprising 4400 patients were included for quantitative analysis. Pooled clinical remission rates for CD were 34% (95% CI, 26%–42%) following induction and 31% (95% CI, 25%–38%) at one year. For UC, post-induction clinical remission rates were 39% (95% CI, 23%–56%). Serious AEs were reported in 5.6% of patients. Pregnancy outcomes were similar to the general population. One-third of patients with active baseline perianal disease responded or had fistula healing with ustekinumab. Conclusions: In the most comprehensive systematic review and meta-analysis to date, and the first to include UC, ustekinumab was shown to be effective and safe in the real-world treatment of IBD.

Original language	English
Journal	Digestive Diseases and Sciences
DOIs	https://doi.org/10.1007/s10620-021-06932-4
Publication status	Accepted/In press - 2021

Keywords

Crohn’s disease
Effectiveness
Real-world
Safety
Ulcerative colitis
Ustekinumab

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10.1007/s10620-021-06932-4

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@article{0925b9230def40c395ad43fb6417149a,

title = "Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis",

abstract = "Introduction: Ustekinumab, an interleukin-12 and interleukin-23 antagonist, is licensed for the treatment of Crohn{\textquoteright}s disease (CD) and ulcerative colitis (UC) after the phase III trial programs demonstrated efficacy over placebo. However, these findings may not be directly transferable to the real-world due to the stringent inclusion criteria of clinical trials. Methods: We conducted a systematic review and meta-analysis of the safety and effectiveness of ustekinumab in inflammatory bowel disease (IBD). A systematic literature search was conducted via Medline and Embase from inception to April 21, 2020. Observational studies assessing ustekinumab{\textquoteright}s safety and effectiveness by reporting response, remission and/or adverse events (AE) in either CD or UC were included. Two reviewers independently assessed risk of bias and extracted study data. Random-effects meta-analysis was performed to pool rates of clinical response, remission, and safety data. Results: Following deduplication, 2147 records were identified of which 41 studies (38 CD, 3 UC) comprising 4400 patients were included for quantitative analysis. Pooled clinical remission rates for CD were 34% (95% CI, 26%–42%) following induction and 31% (95% CI, 25%–38%) at one year. For UC, post-induction clinical remission rates were 39% (95% CI, 23%–56%). Serious AEs were reported in 5.6% of patients. Pregnancy outcomes were similar to the general population. One-third of patients with active baseline perianal disease responded or had fistula healing with ustekinumab. Conclusions: In the most comprehensive systematic review and meta-analysis to date, and the first to include UC, ustekinumab was shown to be effective and safe in the real-world treatment of IBD.",

keywords = "Crohn{\textquoteright}s disease, Effectiveness, Real-world, Safety, Ulcerative colitis, Ustekinumab",

author = "Sailish Honap and Susanna Meade and Hajir Ibraheim and Irving, {Peter M.} and Jones, {Michael P.} and Samaan, {Mark A.}",

note = "Publisher Copyright: {\textcopyright} 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

doi = "10.1007/s10620-021-06932-4",

language = "English",

journal = "Digestive Diseases and Sciences",

issn = "0163-2116",

publisher = "Springer New York LLC",

}

TY - JOUR

T1 - Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease

T2 - A Systematic Review and Meta-Analysis

AU - Honap, Sailish

AU - Meade, Susanna

AU - Ibraheim, Hajir

AU - Irving, Peter M.

AU - Jones, Michael P.

AU - Samaan, Mark A.

PY - 2021

Y1 - 2021

N2 - Introduction: Ustekinumab, an interleukin-12 and interleukin-23 antagonist, is licensed for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) after the phase III trial programs demonstrated efficacy over placebo. However, these findings may not be directly transferable to the real-world due to the stringent inclusion criteria of clinical trials. Methods: We conducted a systematic review and meta-analysis of the safety and effectiveness of ustekinumab in inflammatory bowel disease (IBD). A systematic literature search was conducted via Medline and Embase from inception to April 21, 2020. Observational studies assessing ustekinumab’s safety and effectiveness by reporting response, remission and/or adverse events (AE) in either CD or UC were included. Two reviewers independently assessed risk of bias and extracted study data. Random-effects meta-analysis was performed to pool rates of clinical response, remission, and safety data. Results: Following deduplication, 2147 records were identified of which 41 studies (38 CD, 3 UC) comprising 4400 patients were included for quantitative analysis. Pooled clinical remission rates for CD were 34% (95% CI, 26%–42%) following induction and 31% (95% CI, 25%–38%) at one year. For UC, post-induction clinical remission rates were 39% (95% CI, 23%–56%). Serious AEs were reported in 5.6% of patients. Pregnancy outcomes were similar to the general population. One-third of patients with active baseline perianal disease responded or had fistula healing with ustekinumab. Conclusions: In the most comprehensive systematic review and meta-analysis to date, and the first to include UC, ustekinumab was shown to be effective and safe in the real-world treatment of IBD.

AB - Introduction: Ustekinumab, an interleukin-12 and interleukin-23 antagonist, is licensed for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) after the phase III trial programs demonstrated efficacy over placebo. However, these findings may not be directly transferable to the real-world due to the stringent inclusion criteria of clinical trials. Methods: We conducted a systematic review and meta-analysis of the safety and effectiveness of ustekinumab in inflammatory bowel disease (IBD). A systematic literature search was conducted via Medline and Embase from inception to April 21, 2020. Observational studies assessing ustekinumab’s safety and effectiveness by reporting response, remission and/or adverse events (AE) in either CD or UC were included. Two reviewers independently assessed risk of bias and extracted study data. Random-effects meta-analysis was performed to pool rates of clinical response, remission, and safety data. Results: Following deduplication, 2147 records were identified of which 41 studies (38 CD, 3 UC) comprising 4400 patients were included for quantitative analysis. Pooled clinical remission rates for CD were 34% (95% CI, 26%–42%) following induction and 31% (95% CI, 25%–38%) at one year. For UC, post-induction clinical remission rates were 39% (95% CI, 23%–56%). Serious AEs were reported in 5.6% of patients. Pregnancy outcomes were similar to the general population. One-third of patients with active baseline perianal disease responded or had fistula healing with ustekinumab. Conclusions: In the most comprehensive systematic review and meta-analysis to date, and the first to include UC, ustekinumab was shown to be effective and safe in the real-world treatment of IBD.

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KW - Effectiveness

KW - Real-world

KW - Safety

KW - Ulcerative colitis

KW - Ustekinumab

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DO - 10.1007/s10620-021-06932-4

M3 - Article

AN - SCOPUS:85102809446

SN - 0163-2116

JO - Digestive Diseases and Sciences

JF - Digestive Diseases and Sciences

ER -

Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

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