Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 1999 Apr;58(4):220-5.
doi: 10.1136/ard.58.4.220.

Combination therapy in early rheumatoid arthritis: a randomised, controlled, double blind 52 week clinical trial of sulphasalazine and methotrexate compared with the single components

M Dougados  1 , B Combe, A Cantagrel, P Goupille, P Olive, M Schattenkirchner, S Meusser, L Paimela, R Rau, H Zeidler, M Leirisalo-Repo, K Peldan
Affiliations
Clinical Trial

Combination therapy in early rheumatoid arthritis: a randomised, controlled, double blind 52 week clinical trial of sulphasalazine and methotrexate compared with the single components

M Dougados et al. Ann Rheum Dis. 1999 Apr.

Abstract

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Course of the 52 week randomised controlled trial in RA patients.
Figure 2
Figure 2
Mean changes in selected variables during the study in patients given SASP, MTX or SASP + MTX.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Q J Med. 1968 Jul;37(147):393-406 - PubMed
    1. N Engl J Med. 1995 Jul 20;333(3):137-41 - PubMed
    1. Arthritis Rheum. 1980 Feb;23(2):137-45 - PubMed
    1. Br J Rheumatol. 1995 Jun;34(6):529-34 - PubMed
    1. Arthritis Rheum. 1995 Dec;38(12):1799-806 - PubMed