Abstract | OBJECTIVES: METHOD: Data from five randomized controlled trials (one sulfasalazine-controlled, four placebo-controlled) and four open-label studies evaluating etanercept were pooled for analyses. All randomized subjects who received at least one dose of treatment were included in the study. RESULTS: Analyses included 1323 subjects (> 1500 subject-years of treatment). Rate ratios of serious infections and IBD events for etanercept vs. placebo/ sulfasalazine during the double-blind studies were 2.19 [95% confidence interval (CI) 0.22-107.79] and 1.09 (95% CI 0.06-64.56), respectively. There were no reports of opportunistic infections. Using the Surveillance, Epidemiology and End Results database, the standardized incidence ratio for malignancies was 1.47 (95% CI 0.54-3.21). CONCLUSIONS: These data suggest that etanercept is well tolerated in subjects with AS. Despite the large number of patients, the 95% CI data all cross 1.0, limiting possible conclusions. No new safety signals were observed.
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Authors | D van der Heijde, D Zack, J Wajdula, S Sridharan, A S Koenig |
Journal | Scandinavian journal of rheumatology
(Scand J Rheumatol)
Vol. 43
Issue 1
Pg. 49-53
( 2014)
ISSN: 1502-7732 [Electronic] England |
PMID | 24182312
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antirheumatic Agents
- Immunoglobulin G
- Receptors, Tumor Necrosis Factor
- Etanercept
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Topics |
- Adult
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Clinical Trials as Topic
- Double-Blind Method
- Etanercept
- Female
- Humans
- Immunoglobulin G
(adverse effects, therapeutic use)
- Incidence
- Infections
(chemically induced, epidemiology)
- Inflammatory Bowel Diseases
(chemically induced, epidemiology)
- Male
- Middle Aged
- Neoplasms
(chemically induced, epidemiology)
- Opportunistic Infections
(chemically induced, epidemiology)
- Receptors, Tumor Necrosis Factor
(therapeutic use)
- Retrospective Studies
- Severity of Illness Index
- Spondylitis, Ankylosing
(drug therapy)
- Treatment Outcome
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