Background Current guidelines about rheumatoid arthritis (RA) management might admit tapering schedules of biologic disease modifiying drugs (bDMARDs) when disease activity control has been achieved and maintained, in line with growing scientific evidences . Great heterogeneity in target populations, end-points, study designs, therapeutic protocols, criteria for bDMARD discontinuation and resumption globally prevents from univocal interpretation of study results . Real life data might provide additional information on the topic, which could be better extended to routine care.
Objectives To analyze the impact of a bDMARD down-titration strategy (spacing) on clinical and sub-clinical disease activity control over time (12 months) in real life RA patients attending a single Italian Rheumatologic Unit.
Methods RA patients with at least 1 year of bDMARDs treatment and a well-controlled disease (at least low disease activity/LDA according to DAS28 criteria for at least 6 months) were offered to undergo a spacing (doubling the inter-administration period) of their ongoing bDMARD (anti-TNF, Abatacept/ABA, Tocilizumab/TCZ) medication. When present, concomitant conventional synthetic DMARDs (csDMARDs) and/or low dosage (less than 7,5 mg/d prednisone-equivalent) oral corticosteroid (CS) were admitted and maintained: Group A= CS-on patients; Group B= CS-off patients. Disease activity was monitored every 2 months through DAS28 in order to detect any clinical relapse (>LDA): relapsing Group A patients immediately resumed original bDMARD schedule, relapsing Group B patients started firstly low dose CS (5 mg/d) while keeping on bDMARD spacing. At the same time-points, ultrasonographic (US) assessment (Gray Scale/GS and power Doppler/PD scores) was performed on dorsal view of bilateral hands and wrists. Clinical and US results were analyzed either globally and by CS-co-medication, as to detect any bDMARD sparing effect.
Results Thirty-seven RA patients consented to the bDMARD spacing. Most patients were on anti-TNF agents (4 TCZ, 1 ABA) in association with csDMARDs (7/37 csDMARD free), and without CS co-medication (30/37 CS free). At time of spacing overall clinical (mean DAS28±sd 1,92±0,59), lab (median ESR [IQR] 10,50 [7–16] mm/h, median CRP [IQR] 0,14 [0,10–0,49] mg/dL) and US parameters (median GS score [IQR] 9 [6–13,5], median PD score [IQR] 0 [0–0]) were consistent with disease control; more than half patients had negative prognostic factors. Globally, trends over time of either clinical and US parameters did not significantly differ between groups, regardless of CS co-administration. Nevertheless, over the first year of observation more CS-off than CS-on patients experienced disease relapse (12 versus 4 patients, respectively, p=0,99); this occurred sooner in CS-off patients, too (mainly in the first 6 months of follow up).
Conclusions The feasibility of bDMARDs step-down schedules in RA patients should be clarified in real life setting, as well as in clinical trials. bDMARD spacing might be a possible choice, especially when low dosage CS are co-administered: their eventual bDMARD sparing effect should be confirmed with larger and longer observations, together with complete evaluations about cost-effectiveness and risk-to-benefit profiles.
Smolen JS, et al. Ann Rheum Dis 2014;73:492–509.
Yoshida K, et al. AnnRheumDis 2014;73:595–599.
Disclosure of Interest None declared
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