Literature DB >> 22859920

The role of biologic agents in damage progression in rheumatoid arthritis: indirect comparison of data coming from randomized clinical trials.

Ennio Giulio Favalli1, Francesca Pregnolato, Martina Biggioggero, Pier Luigi Meroni.   

Abstract

OBJECTIVES: All biologic agents approved for the treatment of rheumatoid arthritis (RA) have been tested versus methotrexate (MTX) for efficacy on damage progression in several randomized clinical trials (RCTs), but direct head-to-head comparisons have never been conducted. The purpose of this investigation is to analyse data coming from main RA RCTs and to perform an indirect comparison.
METHODS: A systematic review of literature from 1988 to 2011 was conducted. Only randomized, double-blind, controlled, comparative trials, with evaluation of radiographic progression were included. The radiographic score was standardized and mean difference in the percentage of the annual radiographic progression rate was used as the effect measure. Heterogeneity between studies was estimated by I(2) test. For each trial, the effect was plotted according to its standard error in a funnel plot.
RESULTS: Of 44 potentially relevant trials, 12 RCTs were included in the study. In order to optimize RCTs comparison, studies were stratified in early and late RA group. Main population characteristics were similar in both early and late RA groups, whereas the standardized baseline radiographic score value significantly differs among trials in both early (range 2.7-21.9) and late (range 23.46-75) RA groups. The standardized annual estimated progression is similar across the late RA group. Strong evidence of heterogeneity (I(2) = 97%, p = 0.00001) but no asymmetry of the funnel plot was observed in the early RA group. Total mean difference was -16.28 (95% confidence interval [CI] -24.42 to -8.14). For the late RA group a random model was used (I(2) = 99%, p = 0.00001) and a total mean difference of -39.25 (95% CI -53.77 to -24.73) was found.
CONCLUSIONS: All biologic agents provide a favourable effect on disease progression both in early and late RA. The significant heterogeneity among various RCTs did not allow an effective comparison of the performance of biologic agents in each study.

Entities:  

Keywords:  Rheumatoid arthritis; biologic therapy; metaanalysis; radiographic progression

Year:  2012        PMID: 22859920      PMCID: PMC3403255          DOI: 10.1177/1759720X12449082

Source DB:  PubMed          Journal:  Ther Adv Musculoskelet Dis        ISSN: 1759-720X            Impact factor:   5.346


  25 in total

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9.  Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial).

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10.  Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

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  4 in total

1.  Biologic agents in rheumatoid arthritis: temporal trend of incremental benefits.

Authors:  Andrea Messori; Dario Maratea; Valeria Fadda; Sabrina Trippoli
Journal:  Ther Adv Musculoskelet Dis       Date:  2012-12       Impact factor: 5.346

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