I-TAPER
Research type
Research Study
Full title
Informed TAPEring of disease-modifying therapy for RA patients in stable remission
IRAS ID
252506
Contact name
Paul Emery
Contact email
Sponsor organisation
The University of Leeds
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The optimum treatment target in rheumatoid arthritis (RA) is remission (absence of signs and symptoms). Ideally, this is achieved rapidly by controlling inflammation, thereby preventing structural damage. In practice, treat-to-target (T2T) strategies are used, which employ strict monitoring of disease activity and treatment escalation until a target is achieved. In practice this involves conventional synthetic disease-modifying drugs (csDMARDs) and biologicals (bDMARDs) if the former are ineffective.
Although T2T strategies have led to significantly improved outcomes, many patients still deteriorate, which is thought to be due to the subjective definitions of remission used in clinical practice/trials. Remission biomarkers exist but none have entered routine clinical practice; ultrasound (US) provides an objective assessment of joint inflammation and T-cell abnormalities, key to developing RA, have both been found to be useful in assessing sub-clinical disease.
Once remission is achieved, current practice is to continue therapy (same-dose) long-term, but this may not always be necessary/desirable. Chronic immune-suppressing therapy, particularly bDMARDs, can be associated with adverse events, such as increased infection and cancer risk. The cost of bDMARDs is also considerable. Thus, tapering (reducing treatment with the aim of stopping) for patients in remission is a key management issue.
Although international guidelines recommend tapering once sustained remission (maintenance of remission over time) is achieved, there is no consensus regarding the optimal approach. There is a need to identify predictors of successful tapering. We have undertaken work using clinical, US and T-cell measures which has suggested association of some of these biomarkers with successful tapering.
I-TAPER aims to inform future structured tapering of disease-modifying therapy. For RA patients in stable remission, we will use our biomarker panel to predict if they are likely to taper therapy successfully. Informed-tapering refers to offering tapering to those likely to remain in stable remission over 12 months based on this biomarker panel.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0388
Date of REC Opinion
11 Nov 2020
REC opinion
Further Information Favourable Opinion