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Meta-Analysis
. 2020 Jul;6(2):e001277.
doi: 10.1136/rmdopen-2020-001277.

Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry

Yune-Jung Park  1   2 , Ana Maria Gherghe  3 , Desirée van der Heijde  4
Affiliations
Meta-Analysis

Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry

Yune-Jung Park et al. RMD Open. 2020 Jul.

Abstract

Objectives: To summarise radiographic data in randomised controlled trials (RCTs) as part of the radiographic inhibition claim of disease-modifying antirheumatic drugs (DMARDs) approved for patients with rheumatoid arthritis (RA).

Methods: A systemic literature review was performed using the Medline database from 1994 to February 2020. The results were grouped based on the scoring methods (Sharp, Genant modification, van der Heijde modification) and RA patient populations.

Results: One hundred sixty-eight publications were selected. After detailed assessment, 52 RCTs (7 methotrexate (MTX)-naive, 23 MTX inadequate response (IR), 9 DMARDs IR and 3 tumour necrosis factor-alpha inhibitors (TNFi) IR studies) were finally included. Information on patient population, scoring method used, reader reliability, statistical analyses and detailed radiographic data on baseline and change scores over multiple follow-up periods are presented.

Conclusion: The data gathered in this review serve as a repository for the design of future trials with radiographic damage as an outcome.

Keywords: Ankylosing Spondylitis; Arthritis; Autoimmune Diseases; Inflammation; Outcomes research; Rheumatoid Arthritis; Spondyloarthritis; Synovitis; Systemic Sclerosis.

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Conflict of interest statement

Competing interests: DvdH received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma and is Director of Imaging Rheumatology bv.

Figures

Figure 1
Figure 1
Flow chart of the trial selection process.
See this image and copyright information in PMC

References

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