Background Actually, as suggested from current therapeutic guidelines, tapering of biologic agents (bDMARDs) seems a feasible option in subsets of rheumatoid arthritis (RA) patients in persistent clinical disease control . However definite step-down schedules are far to be fully elucidated due to the heterogeneity of available data in controlled trials. Data on real life contests are even fewer.
Objectives To analyze the feasibility of bDMARD spacing in maintaining clinical disease control in real life RA patients in persistent low disease activity (LDA) or remission. To monitor sub-clinical signs of disease activity during bDMARDs tapering.
Methods RA patients in persistent clinical disease control (at least LDA according to DAS28 score for at least 6 months) underwent current bDMARD (anti-TNF/no anti-TNF agents for at least 1 year) spacing (doubling of the inter-administration time); concomitant co-medications (conventional synthetic DMARDs/csDMARDs and/or low dose oral corticosteroids/CS) were carried on at stable dosages. Clinical and ultrasonographic (US) assessments were performed bi-monthly over initial 6 months period in order to define clinical relapse (> LDA) and to monitor clinical and sub-clinical signs of inflammation (Gray scale, GS, and power Doppler, PD scores detected on hand and wrist US examination). Results about first 4 months of follow up are yet available for preliminary analysis.
Results Globally, 35 patients met the criteria and agreed to the spacing. Most of them had an established disease (mean duration ± sd 11,92±7,80 years) with markers of poor prognosis (57% seropositive patients, 60% patients with erosive disease). They were generally on their first anti-TNF bDMARD therapy (30 anti-TNF, 4 tocilizumab, 1 abatacept) together with csDMARDs co-medication (29/35 patients); they were mostly CS free (28/35 cs-free patients; 7 patients on low dose oral CS). Over 4 months of observation DAS28 score did not significantly change (mean value ± sd from 1,92±0,59 to 1,89±0,63, p not significant), as happened for GS score (median [IQR] from 9 [8-12] to 11 [9-13], p not significant). Median PD score [IQR] significantly increase over time, from 0 [0-0] at baseline examination to 1,5 [0-4] (p=0,01) at 4 months. In 4 months, globally 2 patients relapsed.
Conclusions Biologic DMARDs spacing might be a possible therapeutic option in real life RA patients in persistent disease control: despite the substantial increase in PD score, few patients clinically relapsed in the first months of observation. For a complete evaluation, risk-to-benefit issues should involve long-term clinical, functional and structural outcomes, along with safety and financial issues too. Predictive factors need to be fully elucidated to target patients who might benefit more from this strategy.
Smolen JS, et al. Ann Rheum Dis 2014;73:492–509.
Disclosure of Interest None declared
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