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.
Ann Rheum Dis
; 76(7): 1279-1284, 2017 Jul.
Article
em En
| MEDLINE
| ID: mdl-28389552
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 4â mg/kg TCZ+MTX, 8â mg/kg TCZ+MTX, 8â mg/kg TCZ+placebo or placebo+MTX for 104â weeks. Patients not receiving 8â 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 (8â 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, 8â mg/kg TCZ+MTX, 49.3% to 47.6%). Placebo+MTX and 4â mg/kg TCZ+MTX escape patients' week 104 response rates were 51.4% and 30.5%, respectively. Inhibition of radiographic progression was maintained with 8â mg/kg TCZ (eg, 8â 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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Artrite Reumatoide
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Metotrexato
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Antirreumáticos
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Anticorpos Monoclonais Humanizados
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article