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Cited by 340

The DOI matches its Crossref record; 42 of the 42 references it cites were found in a registry or an index.

A Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial of Etanercept in the Treatment of Alcoholic Hepatitis

Open access
Boetticher, Nicholas C., Peine, Craig J., Kwo, Paul, Abrams, Gary A., Patel, Tushar, Aqel, Bashar, Boardman, Lisa, Gores, Gregory J., Harmsen, William S., McClain, Craig J., Kamath, Patrick S., Shah, Vijay H.·2008·Gastroenterology
DOI 10.1053/j.gastro.2008.08.057
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Abstract

Background Alcoholic hepatitis is a cause of major morbidity and mortality that lacks effective therapies. Both experimental and clinical evidence indicate that the multifunctional cytokine tumor necrosis factor-α (TNFα) contributes to pathogenesis and clinical sequelae of alcoholic hepatitis. A pilot study demonstrated that the TNFα-neutralizing molecule, etanercept, could be an effective treatment for patients with alcoholic hepatitis. Methods Forty-eight patients with moderate to severe alcoholic hepatitis (MELD score ≥15) were enrolled and randomized to groups that were given up to 6 subcutaneous injections of either etanercept or placebo for three weeks. Primary study endpoints included mortality at 1- and 6-month timepoints. Results There were no significant baseline differences between the placebo and etanercept groups in demographics or disease severity parameters including age, gender, and MELD score. The 1-month mortality rates of patients receiving placebo and etanercept were similar on an intention-to-treat basis (22.7% versus 36.4%, respectively; OR and 95% CI: 1.8 and 0.5–6.5). The 6-month mortality rate was significantly higher in the etanercept group, compared with the placebo group (57.7% versus 22.7%, respectively; OR and 95% CI: 4.6 and 1.3–16.4, p=0.017). Rates of infectious serious adverse events were significantly higher in the etanercept group, compared with the placebo group (34.6% versus 9.1%, p=0.04). Conclusion In patients with moderate to severe alcoholic hepatitis, etanercept was associated with a significantly higher mortality rate after 6 months, indicating that etanercept is not effective for the treatment of patients with alcoholic hepatitis.

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Metadata

Authors
Boetticher, N. C., Peine, C. J., Kwo, P., Abrams, G. A., Patel, T., Aqel, B., Boardman, L., Gores, G. J., Harmsen, W. S., McClain, C. J., Kamath, P. S., & Shah, V. H.
Venue
Gastroenterology
Publisher
Elsevier BV
Published
2008-12
Volume
135
Issue
6
Pages
1953-1960
ISSN
0016-5085 (ISSN-L)
DOI
10.1053/j.gastro.2008.08.057
OpenAlex
W2152084270
Cited by
340
References
42
FWCI
14.11
Type
journal article
Language
en
Open access
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Boetticher, N. C., Peine, C. J., Kwo, P., Abrams, G. A., Patel, T., Aqel, B., Boardman, L., Gores, G. J., Harmsen, W. S., McClain, C. J., Kamath, P. S., & Shah, V. H. (2008). A Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial of Etanercept in the Treatment of Alcoholic Hepatitis. Gastroenterology. https://doi.org/10.1053/j.gastro.2008.08.057

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.