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

Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, Gerli R, Hansen MS, Amital H, Xavier RM, Troum O, Bernasconi C, Huizinga TWJ (2014)

Publication Type: Journal article

Publication year: 2014

Journal

Annals of the Rheumatic Diseases BMJ Publishing Group

Book Volume: 73

Pages Range: 803-9

Journal Issue: 5

DOI: 10.1136/annrheumdis-2013-204761

Abstract

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.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>3.2.556 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.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.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

University of Paris 5 - René Descartes / Université Paris V René Descartes FR France (FR) Roche Products Pty Limited AU Australia (AU) University of Leeds GB United Kingdom (GB) Hospital Universitario La Paz ES Spain (ES) Università degli Studi di Perugia IT Italy (IT) Copenhagen University Hospital DK Denmark (DK) Chaim Sheba Medical Center at Tel HaShomer / המרכז הרפואי עש חיים שיבא – תל השומר‎‎ IL Israel (IL) Hospital de Clínicas de Porto Alegre (HCPA) BR Brazil (BR) University of Southern California (USC) US United States (USA) (US) F. Hoffmann-La Roche Ltd CH Switzerland (CH) Leiden University Medical Center NL Netherlands (NL)

How to cite

APA:

Dougados, M., Kissel, K., Conaghan, P.G., Mola, E.M., Schett, G., Gerli, R.,... Huizinga, T.W.J. (2014). Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study. Annals of the Rheumatic Diseases, 73(5), 803-9. https://doi.org/10.1136/annrheumdis-2013-204761

MLA:

Dougados, Maxime, et al. "Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study." Annals of the Rheumatic Diseases 73.5 (2014): 803-9.

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