Background/Purpose:

Prediction which rheumatoid arthritis (RA) patients in low disease activity (LDA) can successfully discontinue TNF inhibition (TNFi) may improve the cost-effectiveness of RA management. We evaluated the multi-biomarker disease activity (MBDA) score, which is based on 12 serum biomarkers, as a predictor of flare after TNF-i discontinuation.

Methods:

Data were used from the 439 RA patients who were randomized to stop TNFi treatment in the Dutch multi-center POET trial.  All patients had been in DAS28 LDA for ≥12 months. In the study TNFi was allowed to be restarted if RA flared according to reimbursement criteria: DAS28 exceeding the 3.2 again, but patients and/or physicians were allowed if DAS increase was minor to escalate the dose from the conventional disease modifiers. In our current analysis 4 definitions of flare were assessed during the 12 months from TNFi discontinuation: 1) re-initiating TNFi treatment, 2) escalation of any medication and 3) physician-reported flare. MBDA score, which measures RA disease activity on a scale of 1 to 100 with validated levels of low (<30), moderate (30 to 44) and high (>44), was assessed at baseline. Associations between baseline MBDA score and each definition of flare by 12 months post-TNFi discontinuation were evaluated using univariate analysis and multivariate logistic regression.

Results: At baseline, 50.1%, 35.3% and 14.6% of patients had low, moderate or high MBDA scores and 94.1%, 5.9%, 0% had low, moderate high DAS28. Within 12 months, 49.9% of patients who discontinued TNFi treatment at baseline had restarted TNFi medication, 59.0% had escalation of any medication and 57.2% had experienced at least one physician-reported flare. MBDA scores at baseline were predictive for each definition of flare. At least one definition of flare was observed by 12 months in 59.5%, 68.4% and 81.3% of patients with low, moderate, or high MBDA score at baseline, respectively (P=0.004) (Table 1). Adjusted for baseline DAS28-ESR, disease duration, BMI and erosions, high MBDA scores (>44) were associated with an increased risk for TNFi re-initiation (OR=1.85, 95% CI 1.00–3.40), medication escalation (OR=1.99, 95% CI 1.01–3.94) and physician-reported flare (OR=2.00, 95% CI 1.06–3.77).

Table 1: Occurrence of flare by four definitions at 12 months for patients classified by baseline MBDA score

Any flare = TNFi re-initation, medication escalation, clinician-reported flare or DAS28 flare. P-value by Pearson χ²test.

Conclusion:

In RA patients with DAS28 LDA, a high MBDA score at baseline was an independent predictor of flare within 12 months of discontinuing TNFi therapy. The MBDA score may be a clinically useful tool for identifying a subgroup of patients at higher risk of flare when stopping TNFi treatment.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/multi-biomarker-disease-activity-score-as-a-predictor-of-flare-in-patients-with-rheumatoid-arthritis-who-stop-tnf-alpha-inhibitor-therapy/