PT  - JOURNAL ARTICLE
AU  - Maxime Dougados
AU  - Karsten Kissel
AU  - Philip G Conaghan
AU  - Emilio Martin Mola
AU  - Georg Schett
AU  - Roberto Gerli
AU  - Michael Sejer Hansen
AU  - Howard Amital
AU  - Ricardo M Xavier
AU  - Orrin Troum
AU  - Corrado Bernasconi
AU  - T W J Huizinga
TI  - Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study
AID  - 10.1136/annrheumdis-2013-204761
DP  - 2014 May 01
TA  - Annals of the Rheumatic Diseases
PG  - 803--809
VI  - 73
IP  - 5
4099  - http://ard.bmj.com/content/73/5/803.short
4100  - http://ard.bmj.com/content/73/5/803.full
SO  - Ann Rheum Dis2014 May 01; 73
AB  - 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. Conventional open-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 patients receiving 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 52 in 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 add-on and switch strategies led to meaningful clinical and radiographic responses.