1. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial
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Tak, Pp, Rigby, Wf, Rubbert Roth, A, Peterfy, Cg, van Vollenhoven RF, Stohl, W, Hessey, E, Chen, A, Tyrrell, H, Shaw, Tm, Aelion J, IMAGE I. n. v. e. s. t. i. g. a. t. o. r. s., Afif, N, Ahmadi, F, Aires, F, Alanis, E, Alonso, Cs, Alten, Rh, Alvaro Gracia JM, Ashrafzadeh, A, Ballina, J, Bambara, Lm, Bao, C, Bell, M, Berney, S, Bessette, L, Birbara, C, Boling, E, Bourgeois, P, Braun, J, Briones, H, Brzezicki, J, Burgos Vargos, R, Burmester, G, Burnett, M, Busch, H, Cabello, E, Calvo, A, Cantagrel, A, Cantini, F, Zea, Ac, Carreño Perez, L, Chavez, J, Shim, Sc, Chindalore, V, Chiriac, R, Codding, C, Danda, D, Del Guidice, J, De Vita, S, Digiovanni, R, Dikranian, A, Eider, W, Fantini, F, Ferraccioli, G, Fietchner, J, Filipowicz Sosnowska, A, Finnanger, B, Fiocco, G, Fleck, M, Fleischmann, R, Fraser, A, Gaudin, P, Gauler, G, Gaylis, N, Gerlag, Dm, Godde, J, Gomez Reino JJ, Gornisiewicz, M, Gough, W, Greenwald, M, Guerra, G, Hackshaw, K, Haentzschel, Hm, Hammond, T, Hazleman, Bl, Heilig, B, Herenius, Mm, Hilliquin, P, Holt, D, Huang, F, Huff, J, Huizinga, T, Isaacs, J, Jaffer, A, Amante, Ej, Jeka, S, Jimenez, R, Jones, G, Jones, R, Kaine, J, Kashif, A, Kaufmann, C, Kay, J, Khraishi, M, Kivitz, A, Klinkhoff, A, Kraag, G, Krystufkova, O, Kucharz, E, Lawson, J, Leirisalo Repo, M, Levin, R, Liang, G, Liang, P, Limonta, M, Lowenstein, M, Rodriguez Lozano, C, Lue, C, Mahowald, M, Maradiaga, M, Maricic, M, Mariette, X, Martin, L, Massarotti, E, Matucci Cerinic, M, Montecucco, Cm, Mazurov, V, Mcnally, J, Mehta, D, Meyer, O, Misra, R, Moreland, Lw, Mueller Ladner, U, Myerson, G, Nasonov, E, Navarra, S, Navarro, F, Neal, N, Olech, E, Olsen, N, Pablos, Jl, Pacheco, C, Pal, S, Palomo, Er, Pandith, V, Penserga, Eg, Prupas, H, Radominski, S, Ramos Remus, C, Reid, D, Riordan, K, Rosenberg, D, Ruiz, A, Saadeh, C, Salvarani, Carlo, Samuels, A, Sanmarti, R, Sarzi Puttini, P, Saxe, P, Schechtman, J, Scoville, C, Sedlackova, M, Sedrish, M, Sejer Hansen, M, Sibilia, J, Siebert, S, Specker, C, Stern, S, Szechinski, J, Tahir, H, Taylor, A, Thompson, Pw, Tony, Hp, Tornero, J, Trapp, R, Tremblay, Jl, Valesini, G, Van Den Bosch, F, Wanchu, A, Wassenberg, S, Ximenes, Ac, Kim, Hy, Zanetakis, E, Zazueta, B, Zerbini, C., Faculteit der Geneeskunde, AII - Amsterdam institute for Infection and Immunity, Clinical Immunology and Rheumatology, and Other departments
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Adult ,musculoskeletal diseases ,medicine.medical_specialty ,Adolescent ,Immunology ,610 Medizin ,Arthritis ,Severity of Illness Index ,Gastroenterology ,Drug Administration Schedule ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Arthritis, Rheumatoid ,Antibodies, Monoclonal, Murine-Derived ,Young Adult ,Double-Blind Method ,Rheumatology ,Randomized controlled trial ,law ,immune system diseases ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Immunology and Allergy ,heterocyclic compounds ,skin and connective tissue diseases ,Aged ,Aged, 80 and over ,ddc:610 ,business.industry ,Middle Aged ,medicine.disease ,Surgery ,Clinical trial ,Methotrexate ,Treatment Outcome ,Antirheumatic Agents ,Rheumatoid arthritis ,Disease Progression ,Drug Therapy, Combination ,Rituximab ,business ,medicine.drug - Abstract
Objectives: Rituximab is an effective treatment in patients with established rheumatoid arthritis (RA). The objective of the IMAGE study was to determine the efficacy of rituximab in the prevention of joint damage and its safety in combination with methotrexate (MTX) in patients initiating treatment with MTX. Methods: In this double-blind randomised controlled phase III study, 755 MTX-naïve patients with active RA were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX. The primary end point at week 52 was the change in joint damage measured using a Genant-modified Sharp score. Results: 249, 249 and 250 patients were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX, respectively. At week 52, treatment with rituximab 2×1000 mg + MTX compared with MTX alone was associated with a reduction in progression of joint damage (mean change in total modified Sharp score 0.359 vs 1.079; p=0.0004) and an improvement in clinical outcomes (ACR50 65% vs 42%; p
- Published
- 2011
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