fbpx
Subscribe
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Advertisment

New EULAR consensus on prevention trials in people at risk of developing RA

Written by | 27 Oct 2021 | Immunology

RA is an inflammatory autoimmune disease that causes pain, swelling and stiffness in the joints. It can also cause fatigue, and the underlying inflammation may affect other body systems. Treating RA quickly after diagnosis and as early as possible after symptom start has been shown to have a significant impact in its further development. With the discovery of the preclinical phase of the disease, the idea of treating people who are at-risk with the aim of preventing RA is very attractive. However, to do this requires carrying out clinical trials to assess the safety and efficacy of treatments in the ‘pre-RA’ phase. Some initial trials in this area have looked at very different populations – with variation in eligibility criteria, biomarkers, interventions, and outcomes. This makes it hard to interpret and compare the evidence as it accumulates.

A EULAR taskforce was set up to develop a set of points to consider for investigators in this important new area. The taskforce included scientists, rheumatologists, and patient representatives. They looked at the published evidence around risk factors and interventions.

In total, 10 points to consider have been produced. These all fall under one overarching principle, which states that all clinical trials and observational studies in people at risk of RA should include the epidemiological and demographic characteristics of the at-risk population being studied. The individual points consider who should take part in trials, and what information they should be given about their risks. They also make suggestions for some study endpoints that should be used across trials.

For trial populations, at-risk participants should be identified according to their clinical presentation. Within this, subpopulations should be identified based on specific risk factors. These risks should be assessed in a population-specific manner, and include a composite of core and emerging risk factors that are assessed at the study start – and potentially repeated throughout. Candidates for clinical trials and observational studies should be informed about their risk of developing RA as this may affect their decision to take part.

The group agreed that the development of subclinical inflammation, clinical arthritis or progression to RA should be considered as study endpoints across trials, whereas disease remission may also be appropriate in people with palindromic rheumatism or undifferentiated arthritis. Clinical trials should evaluate the ability of a specific intervention to modify risk factors as well as progression to RA.

These consensus statements provide guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in people at risk of RA.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Subscribe

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.