Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY).

Annals of the Rheumatic Diseases
Maxime DougadosT W J Huizinga

Abstract

In patients with active rheumatoid arthritis (RA) despite methotrexate, to compare the efficacy of adding tocilizumab to that of switching to tocilizumab monotherapy. Double-blind, 2-year study in which adults with active RA (DAS28 >4.4) despite methotrexate were randomly assigned either to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 8 mg/kg every 4 weeks or switch to tocilizumab and placebo (TCZ+PBO). The primary endpoint was the DAS28-erythrocyte sedimentation rate (ESR) remission rate at week 24. Secondary objectives included other symptomatic outcomes, quality of life and progression of structural damage. Of 556 randomly assigned patients, 512 (92%) completed 24 weeks. DAS28-ESR remission rates were 40.4% for TCZ+MTX and 34.8% for TCZ+PBO (p=0.19); American College of Rheumatology 20/50/70/90 rates were 71.5%/45.5%/24.5%/5.8% (TCZ+MTX) and 70.3%/40.2%/25.4%/5.1% (TCZ+PBO; differences not significant). A significant difference between groups was seen for low DAS28 (61.7% vs 51.4%). Radiographic progression was small and not different between groups (Genant-Sharp score progression ≤ smallest detectable change in 91% (TCZ+MTX) and 87% (TCZ+PBO)). Rates per 100 patient-years of serious adverse events and se...Continue Reading

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Citations

Mar 1, 2012·Zeitschrift für Rheumatologie·K Krüger, J Sieper
Nov 10, 2013·La Revue de médecine interne·T LequerréO Vittecoq
Feb 6, 2013·Nature Reviews. Rheumatology·Maya H BuchPaul Emery
Jan 3, 2014·International Journal of Rheumatic Diseases·Peter Nash, Dave Nicholls
Aug 7, 2013·Annals of the Rheumatic Diseases·Paul EmeryTom W J Huizinga
Jan 24, 2013·Therapeutic Advances in Chronic Disease·Atsushi Kaneko
Apr 15, 2014·Drug Design, Development and Therapy·Anjali ShettyNadera J Sweiss
Aug 31, 2014·Autoimmunity Reviews·Ennio Giulio FavalliPier Luigi Meroni
Dec 7, 2013·Clinical Drug Investigation·Francesca IngegnoliRoberta Gualtierotti
Feb 14, 2014·BioMed Research International·Yuji Yoshida, Toshio Tanaka
Mar 7, 2014·Seminars in Immunology·Toshio TanakaTadamitsu Kishimoto
Sep 6, 2013·Clinical Rheumatology·Paola CiprianiRoberto Giacomelli
Nov 21, 2013·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Sohita Dhillon
Oct 1, 2013·Pharmacology & Therapeutics·Xin YaoYihong Yao
May 17, 2014·Annals of the Rheumatic Diseases·Yoshiya Tanaka, Emilio Martin Mola
Jan 28, 2014·Medicina clínica·Eva Salgado, José Ramón Maneiro
Jun 11, 2015·Expert Opinion on Therapeutic Patents·Young-Won Chin
Aug 21, 2015·Expert Review of Clinical Pharmacology·Sujith Subesinghe, Ian C Scott
Dec 3, 2015·Expert Review of Clinical Immunology·Emma Mitchell, Graeme Jones
Dec 11, 2014·Expert Opinion on Drug Metabolism & Toxicology·Soken-Nakazawa J Song, Kazuyuki Yoshizaki
Apr 29, 2014·Expert Opinion on Investigational Drugs·Luca SemeranoMarie-Christophe Boissier
Jan 15, 2015·Amyloid : the International Journal of Experimental and Clinical Investigation : the Official Journal of the International Society of Amyloidosis·Alice CourtiesUNKNOWN Club Rhumatismes Inflammation and the REGATE Registry
Nov 20, 2015·Clinical Rheumatology·Florenzo IannoneGiovanni Lapadula
Jan 5, 2016·Scandinavian Journal of Rheumatology·H M LindegaardImj Hansen
Feb 6, 2016·Expert Opinion on Biological Therapy·Jessica L Turnier, Hermine I Brunner
Jan 23, 2014·Arthritis & Rheumatology·Julie DucreuxBernard R Lauwerys

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Methods Mentioned

BETA
ESR

Clinical Trials Mentioned

NCT00810199

Software Mentioned

CHARISMA

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