OBJECTIVES: To investigate the potential clinical benefit of a combination therapy. METHODS:205 patients fulfilling the ACR criteria for rheumatoid arthritis (RA), not treated with disease modifying antirheumatoid drugs previously, with an early (< or = 1 year duration), active (Disease Activity Score (DAS) > 3.0), rheumatoid factor and/orHLA DR 1/4 positive disease were randomised between sulphasalazine (SASP) 2000 (maximum 3000) mg daily (n = 68), or methotrexate (MTX) 7.5 (maximum 15) mg weekly (n = 69) or the combination (SASP + MTX) of both (n = 68). RESULTS: The mean changes in the DAS during the one year follow up of the study was -1.15, -0.87, -1.26 in the SASP, MTX, and SASP + MTX group respectively (p = 0.019). However, there was no statistically significant difference in terms of either EULAR good responders 34%, 38%, 38% or ACR criteria responders 59%, 59%, 65% in the SASP, MTX, and SASP + MTX group respectively. Radiological progression evaluated by the modified Sharp score was very modest in the three groups: mean changes in erosion score: +2.4, +2.4, +1.9, in narrowing score: +2.3, +2.1, +1.6 and in total damage score: +4.6, +4.5, +3.5, in the SASP, MTX, and SASP + MTX groups respectively. Adverse events occurred more frequently in the SASP + MTX group 91% versus 75% in the SASP and MTX group (p = 0.025). Nausea was the most frequent side effect: 32%, 23%, 49% in the SASP, MTX, and SASP + MTX groups respectively (p = 0.007). CONCLUSION: This study suggests that an early initiation therapy of disease modifying drug seems to be of benefit. However, this study was unable to demonstrate a clinically relevant superiority of the combination therapy although several outcomes were in favour of this observation. The tolerability of the three treatment modalities seems acceptable.
RCT Entities:
OBJECTIVES: To investigate the potential clinical benefit of a combination therapy. METHODS: 205 patients fulfilling the ACR criteria for rheumatoid arthritis (RA), not treated with disease modifying antirheumatoid drugs previously, with an early (< or = 1 year duration), active (Disease Activity Score (DAS) > 3.0), rheumatoid factor and/or HLA DR 1/4 positive disease were randomised between sulphasalazine (SASP) 2000 (maximum 3000) mg daily (n = 68), or methotrexate (MTX) 7.5 (maximum 15) mg weekly (n = 69) or the combination (SASP + MTX) of both (n = 68). RESULTS: The mean changes in the DAS during the one year follow up of the study was -1.15, -0.87, -1.26 in the SASP, MTX, and SASP + MTX group respectively (p = 0.019). However, there was no statistically significant difference in terms of either EULAR good responders 34%, 38%, 38% or ACR criteria responders 59%, 59%, 65% in the SASP, MTX, and SASP + MTX group respectively. Radiological progression evaluated by the modified Sharp score was very modest in the three groups: mean changes in erosion score: +2.4, +2.4, +1.9, in narrowing score: +2.3, +2.1, +1.6 and in total damage score: +4.6, +4.5, +3.5, in the SASP, MTX, and SASP + MTX groups respectively. Adverse events occurred more frequently in the SASP + MTX group 91% versus 75% in the SASP and MTX group (p = 0.025). Nausea was the most frequent side effect: 32%, 23%, 49% in the SASP, MTX, and SASP + MTX groups respectively (p = 0.007). CONCLUSION: This study suggests that an early initiation therapy of disease modifying drug seems to be of benefit. However, this study was unable to demonstrate a clinically relevant superiority of the combination therapy although several outcomes were in favour of this observation. The tolerability of the three treatment modalities seems acceptable.
Authors: J R O'Dell; C E Haire; N Erikson; W Drymalski; W Palmer; P J Eckhoff; V Garwood; P Maloley; L W Klassen; S Wees; H Klein; G F Moore Journal: N Engl J Med Date: 1996-05-16 Impact factor: 91.245
Authors: P Tugwell; T Pincus; D Yocum; M Stein; O Gluck; G Kraag; R McKendry; J Tesser; P Baker; G Wells Journal: N Engl J Med Date: 1995-07-20 Impact factor: 91.245
Authors: B Combe; R Landewe; C Lukas; H D Bolosiu; F Breedveld; M Dougados; P Emery; G Ferraccioli; J M W Hazes; L Klareskog; K Machold; E Martin-Mola; H Nielsen; A Silman; J Smolen; H Yazici Journal: Ann Rheum Dis Date: 2006-01-05 Impact factor: 19.103
Authors: Josef S Smolen; Robert Landewé; Ferdinand C Breedveld; Maxime Dougados; Paul Emery; Cecile Gaujoux-Viala; Simone Gorter; Rachel Knevel; Jackie Nam; Monika Schoels; Daniel Aletaha; Maya Buch; Laure Gossec; Tom Huizinga; Johannes W J W Bijlsma; Gerd Burmester; Bernard Combe; Maurizio Cutolo; Cem Gabay; Juan Gomez-Reino; Marios Kouloumas; Tore K Kvien; Emilio Martin-Mola; Iain McInnes; Karel Pavelka; Piet van Riel; Marieke Scholte; David L Scott; Tuulikki Sokka; Guido Valesini; Ronald van Vollenhoven; Kevin L Winthrop; John Wong; Angela Zink; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2010-05-05 Impact factor: 19.103