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Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial

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Burmester GR1, Rigby WF2, van Vollenhoven RF3, Kay J4, Rubbert-Roth A5, Blanco R6, Kadva A7, Dimonaco S8. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.

Abstract

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1 Charité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin, Berlin, Germany.

2 Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.

3 Karolinska Institute, Stockholm, Sweden.

4 UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA.

5 University of Cologne, Cologne, Germany.

6 Hospital Universitario Marqués de Valdecilla, Santander, Spain.

7 Genentech, South San Francisco, California, USA.

8 Roche Products Ltd., Welwyn Garden City, UK.

Abstract

OBJECTIVE: Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104.

METHODS: Methotrexate (MTX)-naive patients with early progressive RA were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo or placebo+MTX for 104 weeks. Patients not receiving 8 mg/kg TCZ and not achieving Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) ≤3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory.

RESULTS: Intent-to-treat and safety populations included 1157 and 1153 patients, respectively. DAS28-ESR remission (<2.6) rates were maintained from weeks 52 to 104 (eg, 8 mg/kg TCZ+MTX, 49.3% to 47.6%). Placebo+MTX and 4 mg/kg TCZ+MTX escape patients' week 104 response rates were 51.4% and 30.5%, respectively. Inhibition of radiographic progression was maintained with 8 mg/kg TCZ (eg, 8 mg/kg TCZ+MTX mean (SD) change from baseline in modified total Sharp score: 0.13 (1.28), week 52; 0.19 (2.08), week 104). The safety profile of TCZ was consistent with that of previous reports.

CONCLUSIONS: Patients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals.

TRIAL REGISTRATION NUMBER: NCT01007435; Results.