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Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials

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Abstract

Goals and Background

Ustekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications.

Study

A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18 years or older with a diagnosis of an autoimmune condition.

Results

Thirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16 weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen.

Conclusions

UST was not associated with an increase in short-term risk of AEs.

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Funding

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Authors and Affiliations

  1. Division of Gastroenterology, NYU School of Medicine, New York, NY, USA

    Vineet S. Rolston, Jessica Kimmel, Violeta Popov, Lisa B. Malter & Simon Hong

  2. Division of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd Floor, New York, NY, 10016, USA

    Violeta Popov, Brian P. Bosworth, David Hudesman & Shannon Chang

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  1. Vineet S. Rolston
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Corresponding author

Correspondence to Shannon Chang.

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Conflict of interest

David Hudesman was the consultant for Pfizer, Takeda, Janssen Biotech, Abbvie, and Salix. Research support was from Pfizer. Shannon Chang was the consultant for Takeda, Pfizer, and Oshi Health. Lisa Malter was the consultant for Takeda, Pfizer, Abbvie, Prometheus, Janssen, Merck, UCB, and Gilead. The remaining authors have nothing to disclose.

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Rolston, V.S., Kimmel, J., Popov, V. et al. Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials. Dig Dis Sci 66, 1631–1638 (2021). https://doi.org/10.1007/s10620-020-06344-w

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  • DOI: https://doi.org/10.1007/s10620-020-06344-w

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