Towards the Lowest Efficacious Dose: Results From a Multicenter Noninferiority Randomized Open-Label Controlled Trial Assessing Tocilizumab or Abatacept Injection Spacing in Rheumatoid Arthritis in Remission.
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Kedra Joanna, Dieudé Philippe, Giboin Caroline, Marotte Hubert, Salliot Carine, Schaeverbeke Thierry, Perdriger Aleth, Soubrier Martin, Morel Jacques, Constantin Arnaud, Dernis Emmanuelle, Royant Valérie, Salmon Jean-Hugues, Pham Thao, Gottenberg Jacques-Eric, Pertuiset Edouard, Dougados Maxime, Devauchelle-Pensec Valérie, Gaudin Philippe, Cormier Grégoire, Goupille Philippe, Mariette Xavier, Berenbaum Francis, Alcaix Didier, Rouidi Sid-Ahmed, Berthelot Jean-Marie, Monnier Agnès, Piroth Christine, Lioté Frédéric, Goëb Vincent, Gaujoux-Viala Cécile, Chary-Valckenaere Isabelle, Hajage David, Tubach Florence, Fautrel Bruno, CRI‐IMIDIATE clinical research network
Аннотация
METHODS: This multicenter open-label noninferiority (NI) randomized clinical trial included patients with established rheumatoid arthritis in sustained remission receiving ABA or TCZ at a stable dose. Patients were randomized to treatment maintenance (M) at full dose (M-arm) or progressive injection spacing (S) driven by the Disease Activity Score in 28 joints every 3 months up to biologics discontinuation (S-arm). The primary end point was the evolution of disease activity according to the Disease Activity Score in 44 joints during the 2-year follow-up analyzed per protocol with a linear mixed-effects model, evaluated by an NI test based on the one-sided 95% confidence interval (95% CI) of the slope difference (NI margin 0.25). Other end points were flare incidence and structural damage progression.
RESULTS: Overall, 202 of the 233 patients included were considered for per protocol analysis (90 in S-arm and 112 in M-arm). At the end of follow-up, 16.2% of the patients in the S-arm could discontinue their biologic disease-modifying antirheumatic drug, 46.9% tapered the dose and 36.9% returned to a full dose. NI was not demonstrated for the primary outcome, with a slope difference of 0.10 (95% CI 0.10-0.31) between the two arms. NI was not demonstrated for flare incidence (difference 42.6%, 95% CI 30.0-55.1) or rate of structural damage progression at two years (difference 13.9%, 95% CI -6.7 to 34.4).
CONCLUSION: The Towards the Lowest Efficacious Dose trial failed to demonstrate NI for the proposed ABA or TCZ tapering strategy.