PT  - JOURNAL ARTICLE
AU  - Maxime Dougados
AU  - Bernard Combe
AU  - Alain Cantagrel
AU  - Philippe Goupille
AU  - Patrick Olive
AU  - Manfred Schattenkirchner
AU  - S Meusser
AU  - L Paimela
AU  - Rolf Rau
AU  - Henning Zeidler
AU  - Marjatta Leirisalo-Repo
AU  - Kristiina Peldan
TI  - Combination therapy in early rheumatoid arthritis: a randomised, controlled, double blind 52 week clinical trial of sulphasalazine and methotrexate compared with the single components
AID  - 10.1136/ard.58.4.220
DP  - 1999 Apr 01
TA  - Annals of the Rheumatic Diseases
PG  - 220--225
VI  - 58
IP  - 4
4099  - http://ard.bmj.com/content/58/4/220.short
4100  - http://ard.bmj.com/content/58/4/220.full
SO  - Ann Rheum Dis1999 Apr 01; 58
AB  - 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 anti-rheumatoid drugs previously, with an early (⩽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.