Background Step-down therapeutic strategies may be considered in established rheumatoid arthritis (RA) once remission is achieved.
Objectives To compare the impact of a DAS28-driven step-down strategy based on progressive injection spacing (S arm) to a strategy maintaining the therapy at full regimen (M arm) in an equivalence randomized controlled trial conducted in established RA patients treated with etanercept (ETA) or adalimumab (ADA) in stable DAS28 remission.
Methods Inclusion criteria were: RA ACR1987+, ETA or ADA > 1 year as monotherapy or in combination, daily prednisone ≤ 5 mg/d, DAS28 remission > 6 months, stable X-ray structural damage. Patients were randomized in 2 arms and followed 3-monthly for 18 months. In the S arm, the interval between 2 injections was increased by 50% every 3 months up to full stop at 4th step. If DAS28 remission was lost, tapering was suspended or reversed to the previous step based on DAS28 change. The primary endpoint was disease activity on repeated DAS28 measures (every 3 months over 18 months) under the hypothesis of non-inferiority (mixed linear model).
Results 137 patients were included, 64 and 73 in the S and M arms. Main baseline characteristics were (mean / %): age 55 yrs, female 78%, RA duration 9.5 yrs, RF+ 68%, ACPA+ 78%, erosive disease 88%, DAS28 1.8, DAS44 1.0, HAQ 0.4, previous DMARDs 2.7, ETA 54 %, ADA 46 %. At 18 months, 24 (37.5%) of the S-arm patients had stopped and 23 (35.9%) tapered TNF-blockers. Mean DAS28 and HAQ were not significantly different between the 2 arms (figures). However, the equivalence between the 2 strategies was not demonstrated (p = 0.6). Predictors of persistent remission were low DAS28 at baseline and M strategy. There was no difference between ETA or ADA, either montotherapy or in combination.
Conclusions Spacing of TNF-blockers was feasible in 87% of patients. Although we failed to demonstrate the equivalence between the 2 strategies, the spacing strategy did not result in a significant increase in disease activity or functional impairment. (ClinicalTrials.gov n°: NCT00780793).
Disclosure of Interest None Declared
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