Clinical efficacy, radiographic and safety findings through 5â
years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study).
Ann Rheum Dis
; 73(9): 1689-94, 2014 Sep.
Article
em En
| MEDLINE
| ID: mdl-24748630
ABSTRACT
OBJECTIVES:
Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).METHODS:
Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50â mg, or golimumab 100â mg every 4â weeks (q4wks) through wk20. All patients received golimumab 50â mg or 100â mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5â years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs).RESULTS:
126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20 62.8-69.9%, DAS28-CRP 75.2-84.9% for randomised patients; PASI75 60.8-72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS 0.1-0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate).CONCLUSIONS:
Long-term golimumab safety/efficacy in PsA was demonstrated through 5â years. TRIAL REGISTRATION NUMBER NCT00265096.
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Artrite Psoriásica
/
Antirreumáticos
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Anticorpos Monoclonais
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article