BACKGROUND: To investigate whether intensive treatment with methotrexate (MTX) according to a strict protocol and a computerised decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis. METHODS: In a two-year multicentre open label strategy trial, 299 patients with early rheumatoid arthritis were randomly assigned to the intensive strategy group or the conventional strategy group. Patients in both groups received MTX, the aim of treatment being remission. Patients in the intensive treatment group came to the outpatient clinic once every month; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria, using a computerised decision program. Patients of the conventional strategy group came to the outpatient clinic once every three months; they were treated according to common practice. Cyclosporine was added if patients had an inadequate response to maximal tolerated MTX doses. RESULTS:Seventy six (50%) patients in the intensive strategy group achieved at least one period of remission during the two year trial, versus 55 patients (37%) in the conventional strategy group (p = 0.03). Areas under the curve for nearly all clinical variables were significantly lower-that is, there was a better clinical effect for the intensive treatment group compared with the conventional treatment group. CONCLUSION: The results of this study show that it is possible to substantially enhance the clinical efficacy early in the course of the disease by intensifying treatment with MTX, aiming for remission, tailored to the individual patient. Furthermore, participating rheumatologists indicated that the computerised decision program could be a helpful tool in their daily clinical practice.
RCT Entities:
BACKGROUND: To investigate whether intensive treatment with methotrexate (MTX) according to a strict protocol and a computerised decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis. METHODS: In a two-year multicentre open label strategy trial, 299 patients with early rheumatoid arthritis were randomly assigned to the intensive strategy group or the conventional strategy group. Patients in both groups received MTX, the aim of treatment being remission. Patients in the intensive treatment group came to the outpatient clinic once every month; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria, using a computerised decision program. Patients of the conventional strategy group came to the outpatient clinic once every three months; they were treated according to common practice. Cyclosporine was added if patients had an inadequate response to maximal tolerated MTX doses. RESULTS: Seventy six (50%) patients in the intensive strategy group achieved at least one period of remission during the two year trial, versus 55 patients (37%) in the conventional strategy group (p = 0.03). Areas under the curve for nearly all clinical variables were significantly lower-that is, there was a better clinical effect for the intensive treatment group compared with the conventional treatment group. CONCLUSION: The results of this study show that it is possible to substantially enhance the clinical efficacy early in the course of the disease by intensifying treatment with MTX, aiming for remission, tailored to the individual patient. Furthermore, participating rheumatologists indicated that the computerised decision program could be a helpful tool in their daily clinical practice.
Authors: C H van Jaarsveld; J W Jacobs; M J van der Veen; A A Blaauw; A A Kruize; D M Hofman; H L Brus; G A van Albada-Kuipers; A H Heurkens; E J ter Borg; H C Haanen; C van Booma-Frankfort; Y Schenk; J W Bijlsma Journal: Ann Rheum Dis Date: 2000-06 Impact factor: 19.103
Authors: P E Lipsky; D M van der Heijde; E W St Clair; D E Furst; F C Breedveld; J R Kalden; J S Smolen; M Weisman; P Emery; M Feldmann; G R Harriman; R N Maini Journal: N Engl J Med Date: 2000-11-30 Impact factor: 91.245
Authors: Robert B M Landewé; Maarten Boers; Arco C Verhoeven; Rene Westhovens; Mart A F J van de Laar; Harry M Markusse; J Christiaan van Denderen; Marie Louise Westedt; Andre J Peeters; Ben A C Dijkmans; Piet Jacobs; Annelies Boonen; Désirée M F M van der Heijde; Sjef van der Linden Journal: Arthritis Rheum Date: 2002-02
Authors: J Fransen; G Stucki; J Twisk; A-M Chamot; J-C Gerster; T Langenegger; M Seitz; B A Michel Journal: Ann Rheum Dis Date: 2003-07 Impact factor: 19.103
Authors: Mark C Genovese; Joan M Bathon; Richard W Martin; Roy M Fleischmann; John R Tesser; Michael H Schiff; Edward C Keystone; Mary Chester Wasko; Larry W Moreland; Arthur L Weaver; Joseph Markenson; Grant W Cannon; George Spencer-Green; Barbara K Finck Journal: Arthritis Rheum Date: 2002-06
Authors: Michael E Weinblatt; Edward C Keystone; Daniel E Furst; Larry W Moreland; Michael H Weisman; Charles A Birbara; Leah A Teoh; Steven A Fischkoff; Elliot K Chartash Journal: Arthritis Rheum Date: 2003-01
Authors: Daniel H Solomon; Bing Lu; Zhi Yu; Cassandra Corrigan; Leslie R Harrold; Josef S Smolen; Liana Fraenkel; Jeffrey N Katz; Elena Losina Journal: Arthritis Care Res (Hoboken) Date: 2018-10 Impact factor: 4.794
Authors: Daniel H Solomon; Elena Losina; Bing Lu; Agnes Zak; Cassandra Corrigan; Sara B Lee; Jenifer Agosti; Asaf Bitton; Leslie R Harrold; Theodore Pincus; Helga Radner; Zhi Yu; Josef S Smolen; Liana Fraenkel; Jeffrey N Katz Journal: Arthritis Rheumatol Date: 2017-05-31 Impact factor: 10.995
Authors: Leslie R Harrold; Becky A Briesacher; Dan Peterson; Ashley Beard; Jeanne Madden; Fang Zhang; Jerry H Gurwitz; Stephen B Soumerai Journal: J Rheumatol Date: 2013-01-15 Impact factor: 4.666