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Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

Emery, P ; Deodhar, A ; Rigby, W F ; Isaacs, J D ; Combe, B ; Racewicz, A J ; Latinis, K ; Abud-Mendoza, C ; Szczepański, L J ; Roschmann, R A ; Chen, A ; Armstrong, G K ; Douglass, W ; Tyrrell, H

Annals of the rheumatic diseases, 2010-09, Vol.69 (9), p.1629-1635 [Periódico revisado por pares]

London: BMJ Publishing Group Ltd and European League Against Rheumatism

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Título:
Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))
Autor: Emery, P ; Deodhar, A ; Rigby, W F ; Isaacs, J D ; Combe, B ; Racewicz, A J ; Latinis, K ; Abud-Mendoza, C ; Szczepański, L J ; Roschmann, R A ; Chen, A ; Armstrong, G K ; Douglass, W ; Tyrrell, H
Assuntos: Adult ; Aged ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents - administration & dosage ; Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - immunology ; Biological and medical sciences ; Bones, joints and connective tissue. Antiinflammatory agents ; Clinical and Epidemiological Research ; Diseases of the osteoarticular system ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; Drug Therapy, Combination ; Female ; Humans ; Immunomodulators ; Inflammatory joint diseases ; Male ; Medical sciences ; Methotrexate ; Methotrexate - adverse effects ; Methotrexate - therapeutic use ; Middle Aged ; Neutrophils ; Pharmacology. Drug treatments ; Rheumatism ; Rheumatoid arthritis ; Rituximab ; Severity of Illness Index ; Treatment Outcome ; Tumor necrosis factor-TNF ; Variance analysis
É parte de: Annals of the rheumatic diseases, 2010-09, Vol.69 (9), p.1629-1635
Notas: href:annrheumdis-69-1629.pdf
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Descrição: Objectives This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Methods Patients with active disease on stable MTX (10–25 mg/week) were randomised to rituximab 2×500 mg (n=168), rituximab 2×1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) ≥2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2×500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. Results At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2×500 mg) + MTX, rituximab (2×1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Conclusions Rituximab (at 2×500 mg and 2×1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses.
Editor: London: BMJ Publishing Group Ltd and European League Against Rheumatism
Idioma: Inglês

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Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

Emery, P ; Deodhar, A ; Rigby, W F ; Isaacs, J D ; Combe, B ; Racewicz, A J ; Latinis, K ; Abud-Mendoza, C ; Szczepański, L J ; Roschmann, R A ; Chen, A ; Armstrong, G K ; Douglass, W ; Tyrrell, H

London: BMJ Publishing Group Ltd and European League Against Rheumatism

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