Abstract:
:BACKGROUND. Adalimumab (ADA), an antitumor necrosis factor (anti-TNF) monoclonal antibody, is effective in treating moderate-to-severely active Crohn's disease (CD). ADA has been associated with a variety of adverse events (AE). The purpose of this study is to determine the safety and efficacy of ADA in CD patients in clinical practice. METHODS. A retrospective analysis was performed on CD patients treated with ADA. Data extracted and analyzed included patient and CD demographics, remission and response rates with ADA, and safety and tolerability of ADA. RESULTS. A total of 149 ADA-treated CD patients were included. The mean duration of therapy with ADA was 20 months with 32% of patients discontinuing treatment. Anti-TNF-naïve and anti-TNF-exposed patients on ADA achieved clinical remission in 45% and 32%, had a clinical response in 23% and 23%, and had no clinical response in 32% and 45%, respectively. Anti-TNF-naïve and anti-TNF-exposed patients maintained remission in 82% and 67%, respectively. Fistulas healed in 19% and improved in 19%. AE occurred in 38% of patients with infection being the most common (20%). Serious infections lead to death in one (<1%). Logistic regression of AE did not identify statistically significant predictors except for colonic disease location (odds ratio [OR] = 0.31, 95% CI = 0.12-0.82, p = 0.018) and the rate of ADA discontinuation (OR = 3.24, 95% CI = 1.58-6.64, p = 0.0013). CONCLUSION. ADA is an effective treatment for CD. AE can occur commonly leading to discontinuation of medication and may be influenced by disease location. Although serious complications are rare, close monitoring of all patients on ADA is needed.
journal_name
Scand J Gastroenteroljournal_title
Scandinavian journal of gastroenterologyauthors
Teriaky A,Gregor J,Yan B,Ponich T,Chande N,Mosli Mdoi
10.3109/00365521.2013.865785subject
Has Abstractpub_date
2014-03-01 00:00:00pages
280-6issue
3eissn
0036-5521issn
1502-7708journal_volume
49pub_type
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journal_title:Scandinavian journal of gastroenterology
pub_type: 杂志文章
doi:10.3109/00365521.2015.1124282
更新日期:2016-01-01 00:00:00
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journal_title:Scandinavian journal of gastroenterology
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doi:10.3109/00365528708991915
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journal_title:Scandinavian journal of gastroenterology
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doi:10.3109/00365528608996452
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journal_title:Scandinavian journal of gastroenterology
pub_type: 临床试验,杂志文章
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pub_type: 临床试验,杂志文章
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2000-09-01 00:00:00
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doi:10.3109/00365521.2012.741618
更新日期:2013-02-01 00:00:00
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pub_type: 杂志文章
doi:10.3109/00365529008998551
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更新日期:1999-12-01 00:00:00
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更新日期:1988-04-01 00:00:00