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Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial.
Kremer, Joel M; Blanco, Ricardo; Halland, Anne-Marie; Brzosko, Marek; Burgos-Vargas, Ruben; Mela, Christopher M; Rowell, Lucy; Fleischmann, Roy M.
Afiliación
  • Kremer JM; Albany Medical College, Albany, New York, USA. jkremer@joint-docs.com.
  • Blanco R; Hospital Marques de Valdecilla, IDIVAL, Santander, Spain.
  • Halland AM; Panorama Medical Center, Cape Town, South Africa.
  • Brzosko M; Rheumatology and Internal Diseases Clinic, Pomeranian Medical University, Szczecin, Poland.
  • Burgos-Vargas R; Hospital General de México and Universidad Nacional Autónoma de México, Mexico City, Mexico.
  • Mela CM; Roche Products Ltd., Welwyn Garden City, UK.
  • Rowell L; Roche Products Ltd., Welwyn Garden City, UK.
  • Fleischmann RM; Metroplex Clinical Research Center, Dallas, Texas, USA.
Clin Exp Rheumatol ; 34(4): 625-33, 2016.
Article en En | MEDLINE | ID: mdl-27087059
OBJECTIVES: To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab. METHODS: LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose. RESULTS: 1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR <2.6, EULAR good/moderate response and Boolean remission - as was physical function. The safety profile over 5 years was similar to that over 2 years. CONCLUSIONS: Over 5 years, tocilizumab + MTX inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in MTX-inadequate responders with active disease; no new safety signals occurred.
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Bases de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos / Anticuerpos Monoclonales Humanizados / Articulaciones Tipo de estudio: Clinical_trials Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Clin Exp Rheumatol Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos
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Bases de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos / Anticuerpos Monoclonales Humanizados / Articulaciones Tipo de estudio: Clinical_trials Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Clin Exp Rheumatol Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos