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

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.

• Publication year

  2020

• Venue

  RMD Open

• Publication date

  2020-07-01

• Fields of study

  Medicine

• Identifiers
  DOI 10.1136/rmdopen-2020-001277PMID 32669455PMCID 7425197
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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