Background/Purpose For patients with early RA (eRA), methotrexate (MTX) is recommended as first-line treatment and in non-responders both the addition of conventional non-biological disease modifying anti-rheumatic drug therapy (triple DMARD therapy) and of biological (anti-TNF) therapy are supported by data. Identification of patients with a higher likelihood of responding to one or the other of these options would lead to more personalized medicine and an increased effectiveness of therapy. The objective of this study was to evaluate the change in the multi-biomarker disease activity (MBDA) score (Vectra DA^®) during MTX therapy as a predictor of response to subsequent non-biological triple versus biological therapy.

Methods Patients with eRA and DAS28>3.2 entered the Swedish Farmacotherapy (SWEFOT) clinical trial and received MTX monotherapy for 3 months, at which time clinical non-responders (DAS28>3.2) were randomized to receive non-biological triple DMARD therapy (arm A) or anti-TNF (infliximab) therapy with MTX (arm B). For this study, 129 non-responders at month 3 (n=62 from arm A and n=67 from arm B) were analyzed by MBDA score at baseline (BL) and month 3. The assessment of changes in the MBDA score (ΔMBDA) from BL to month 3 as a predictor for response (according to DAS28 and EULAR response criteria) to triple or anti-TNF therapy at year 1 was done by defining small (≤6), moderate (7-20) and large (>20) decreases by tertiles. Small and moderate decreases were combined together (small/moderate) and compared versus large decreases for arms A and B. The proportion of patients in arm A versus arm B with response at year 1 was evaluated by the odds ratio (OR) for patients with small/moderate versus large decreases. Homogeneity of the odds ratios between the two cohorts was assessed by Breslow-Day test.

Results The mean (median) decreases in MBDA score from BL to month 3 for year 1 responders (n=66) and non-responders (n=63) were 12.9 (10) and 10.8 (9), respectively (p=0.431), and Month 3 mean (median) MBDA scores were 47.1 (45) and 50.3 (47), respectively (p=0.336). Of patients who had small/moderate decreases in MBDA score during MTX monotherapy, 43% responded to subsequent triple therapy and 57% responded to anti-TNF (OR=0.577). In contrast, among patients with a large decreases in MBDA score from BL to month 3, 67% responded to subsequent triple therapy and 37% to anti-TNF treatment (OR=3.33). Thus the relative treatment effect of arm A versus arm B differed according to the degree of change in the MBDA score from BL to 3 months (p=0.032). Similarly, good EULAR response was achieved by the majority (67%) of patients from arm A, who had large decrease in MBDA score and also the majority (57%) of patients from arm B, who had small/moderate decrease of the MBDA score.

Conclusion Among patients with early RA who did not achieve low disease activity on MTX monotherapy, those patients with the greatest decrease in MDBA score were more likely to respond to triple therapy whereas patients with lesser decrease of the MBDA score were more likely to respond to anti-TNF therapy. These findings suggest that in MTX non-responders, the changes in MBDA score may help guide subsequent therapy.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/in-early-rheumatoid-arthritis-patients-with-non-response-to-methotrexate-monotherapy-the-change-in-multi-biomarker-disease-activity-score-is-differentially-associated-with-subsequent-response-to-non-b/