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Lookup NU author(s): Dr Leher Gumber, Dr Fiona Rayner, Dr Theophile BigirumurameORCiD, Dr Bernard Dyke, Sean Kerrigan, Najib NaamaneORCiD, Jon Prichard, Professor Christopher Buckley, Professor Iain McInnes, Professor Karim Raza, Dr Stefan Siebert, Professor James WasonORCiD, Professor Fai Ng, Dr Amy AndersonORCiD, Professor John IsaacsORCiD, Dr Ken BakerORCiD, Dr Arthur PrattORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2025 BMJ Publishing Group. All rights reserved. Objectives Drug withdrawal in rheumatoid arthritis (RA) in remission can reduce toxicity, but with the risk of flare which requires close monitoring. We explored the potential of patient-reported outcomes (PROs) for flare detection among RA patients in sustained remission after conventional synthetic disease-modifying antirheumatic drug (csDMARD) cessation. Methods Four PROs (Factors that Limit sustAined Remission in rhEumatoid arthritis (FLARE-RA), EuroQol-5 Dimensions (EQ5D), Routine Assessment of Patient Index Data-3 (RAPID-3) and RA Flare Questionnaire (RA-FQ)) were captured at baseline and at sequential visits until time-of-flare or end of 6-month follow-up as part of the BIO-FLARE prospective cohort study. Flare was defined as any of (i) Disease Activity Score 28 (DAS28)-C reactive protein (CRP) ≥3.2 at any visit, (ii) DAS28-CRP≥2.4 on two visits within 2 weeks or (iii) resuming DMARD and/or steroid therapy despite DAS28-CRP<2.4. Cox regression models with time-varying covariates were fitted to evaluate associations between PRO changes and likelihood of flare. Receiver-operating characteristic (ROC) curves enabled discriminatory changes in each PRO to be compared as a means of identifying flare. Results 58/121 (47.9%) participants (70.1% females, mean age 64.8 years) experienced a flare. A 1-point change in each PRO score was strongly associated with flare development in the multivariate Cox regression model (p<0.001 in each case). ROC curve analysis confirmed that monitoring adverse changes in PROs from baseline offered robust discriminatory utility for identifying flare occurrence. This was most evident for RA-FQ and FLARE-RA (both areas under the curves 0.90, 95% CI 0.84 to 0.96; p=0.001); for example, an RA-FQ increment of ≥5.5 from baseline identified objective flare with positive and negative predictive values of 80% and 91%, respectively. Conclusions Our data support the potential value of remote PRO monitoring of RA patients in drug-free remission to identify flare occurrence.
Author(s): Gumber L, Rayner F, Bigirumurame T, Dyke B, Melville A, Kerrigan S, McGucken A, Naamane N, Prichard J, Buckley CD, Filer A, McInnes IB, Raza K, Siebert S, Wason JMS, Ng W-F, Anderson AE, Isaacs JD, Baker KF, Pratt AG
Publication type: Article
Publication status: Published
Journal: RMD Open
Year: 2025
Volume: 11
Issue: 2
Online publication date: 01/04/2025
Acceptance date: 18/03/2025
Date deposited: 15/04/2025
ISSN (electronic): 2056-5933
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/rmdopen-2025-005442
DOI: 10.1136/rmdopen-2025-005442
Data Access Statement: Data are available on reasonable request. Data are available from the corresponding author on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.
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