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Comparison of joint destruction between standard- and low-dose etanercept in rheumatoid arthritis from the Prevention of Cartilage Destruction by Etanercept (PRECEPT) study.
- Source :
-
Rheumatology . Dec2012, Vol. 51 Issue 12, p2164-2169. 6p. 1 Chart, 1 Graph. - Publication Year :
- 2012
-
Abstract
- Objective. To evaluate the prevention of joint destruction and clinical efficacy of low-dose etanercept (ETN) (25 mg/week) compared with standard-dose ETN (50 mg/week) in RA.Methods. In this prospective, randomized, open-label study, 70 patients were assigned to receive ETN at either 50 or 25 mg/week for 52 weeks. The primary endpoint was the variation in modified total Sharp score (mTSS), and secondary endpoints were variations in disease activity score in 28 joints (DAS-28), modified HAQ and adverse event rate. Values of mTSS were calculated at baseline and after 52 weeks. Non-progression was estimated as ΔmTSS ≤0.5, and the non-progression rate was compared between groups.Results. Mean values at baseline were as follows: disease duration 9.2 years; DAS-28 5.45; and annual progression of mTSS 26.1. No significant differences in background were seen between groups. At 52 weeks, the non-progression rate was significantly less in the 25 mg/week group (36.7%) than in the 50 mg/week group (67.7%) (P = 0.041). Mean ΔmTSS was higher at 25 mg/week (1.03) than at 50 mg/week (−0.13). DAS-28 was significantly improved at 4 weeks, and the effect of treatment lasted for 52 weeks in both groups. No differences in adverse event rates were seen between groups.Conclusion. Low-dose ETN is not inferior to standard-dose ETN in terms of effects on clinical manifestations. However, in terms of the radiographic non-progression rate, the effects of low-dose ETN may be inferior to the effects of standard-dose ETN.Trial Registration: UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/, UMIN000001798. [ABSTRACT FROM PUBLISHER]
- Subjects :
- *ACADEMIC medical centers
*ANALYSIS of covariance
*BIOMARKERS
*BLOOD testing
*CONFIDENCE intervals
*DIAGNOSTIC imaging
*DOSE-response relationship in biochemistry
*FISHER exact test
*LONGITUDINAL method
*MULTIVARIATE analysis
*QUESTIONNAIRES
*RHEUMATOID arthritis
*STATISTICS
*TUMOR necrosis factors
*U-statistics
*LOGISTIC regression analysis
*DATA analysis
*ETANERCEPT
*RANDOMIZED controlled trials
*INTER-observer reliability
*DESCRIPTIVE statistics
*CHEMICAL inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 14620324
- Volume :
- 51
- Issue :
- 12
- Database :
- Academic Search Index
- Journal :
- Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 83932662
- Full Text :
- https://doi.org/10.1093/rheumatology/kes188