Article Text
Abstract
Background Tapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms. This study aims to investigate if psychological states predict flare in patients’ dose tapering their anti-TNF therapy.
Methods This study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form Survey (SF-36)) were collected at baseline. The primary outcome was flare, defined as an increase in 28-joint count Disease Activity Score (DAS28) ≥0.6 and ≥1 swollen joint. Discrete-time survival models were used to identify patient-reported outcomes that predict flare.
Results Ninety-seven patients were randomised to taper their anti-TNF dose by either 33% or 66%. Forty-one patients flared. Higher baseline DAS28 score was associated with flare (adjusted HR 1.96 (95% CI 1.18 to 3.24), p=0.01). Disability (SF-36 physical component score), fatigue (FACIT-F) and mental health (SF-36 mental health subscale (MH)) predicted flare in unadjusted models. In multivariate analyses, only SF-36 MH remained a statistically significant predictor of flare (adjusted HR per 10 units 0.74 (95% CI 0.60 to 0.93), p=0.01).
Conclusions Baseline DAS28 and mental health status are independently associated with flare in patients who taper their anti-TNF therapy. Fatigue and function also associate with flare but the effect disappears when adjusting for confounders. Given these findings, mental health and functional status should be considered in anti-TNF tapering decisions in order to optimise the likelihood of success.
Trial registration numbers EudraCT Number: 2010-020738-24; ISRCTN28955701; Post-results.
- rheumatoid arthritis
- anti-tnf
- psychology
- disease activity
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Footnotes
Contributors KB and FES led the analysis and drafting of the manuscript. KB coordinated the submission. DLS, FI and AC designed the OPTTIRA study. SN advised on the statistical analysis. FI provided the trial data. JG supervised the analyses and contributed to drafting the manuscript. FM, DLS and AC contributed to the writing of the manuscript. All authors read and approved the final manuscript.
Funding The OPTTIRA trial was funded by Arthritis Research UK (grant reference number 18813); Infrastructure funding for the Experimental Arthritis Treatment Centre at King’s was also provided by Arthritis Research UK. This work was supported by Medical Research Council (CTRF- MR/R001332/1 to KB).
Competing interests None declared.
Patient consent Not required.
Ethics approval The study was approved by the local ethics committee and was conducted according to the guidelines of the Declaration of Helsinki (REC Ref:10/H0720/69).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data sharing would require institutional approval but summary data from the OPTTIRA trial is available from the corresponding author on reasonable request.