Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: The ACT-RAY study

Maxime Dougados, Karsten Kissel, Philip G. Conaghan, Emilio Martin Mola, Georg Schett, Roberto Gerli, Michael Sejer Hansen, Howard Amital, Ricardo M. Xavier, Orrin Troum, Corrado Bernasconi, T. W.J. Huizinga

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Abstract

Objective : To assess the 1-year efficacy and safety of a regimen of tocilizumab plus methotrexate or placebo, which was augmented by a treat-to-target strategy from week 24. Methods : ACT-RAY was a double-blind, 3-year trial. Adults with active rheumatoid arthritis despite methotrexate were randomised to add tocilizumab to ongoing methotrexate (add-on strategy) or to switch to tocilizumab plus placebo (switch strategy). Tocilizumab 8 mg/kg was administered every 4 weeks. Conventionalopen-label disease-modifying antirheumatic drugs (DMARDs) other than methotrexate were added at week 24 or later in patients with DAS28>3.2.Results : 556 patients were randomised; 85% completed 52 weeks. The proportion of patientsreceiving open-label DMARDs was comparable in the add-on (29%) and switch (33%) arms. Overall, week 24 results were maintained or further improved at week 52in both arms. Some endpoints favoured the add-on strategy. Mean changes in Genant-modified Sharp scores were small; more add-on (92.8%) than switch patients (86.1%) had no radiographic progression. At week 52,comparable numbers of patients had antidrug antibodies (ADAs; 1.5% and 2.2% of add-on and switch patients, respectively) and neutralising ADAs (0.7% and 1.8%). Rates of serious adverse events and serious infections per 100 patient-year (PY) were 11.3 and 4.5 in add-on and 16.8 and 5.5 in switch patients. In patients with normal baseline values, alanine aminotransferase elevations >3× upper limit of normal were observed in 11% of add-on and 3% of switch patients. Conclusions: Despite a trend favouring the add-on strategy, these data suggest that both tocilizumab addon and switch strategies led to meaningful clinical and radiographic responses.

Original languageEnglish
Article number73
Pages (from-to)803-809
Number of pages7
JournalAnnals of the Rheumatic Diseases
Volume73
Issue number5
DOIs
StatePublished - May 2014
Externally publishedYes

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