, Volume 14, Issue 5, pp 531-536

A double-blind controlled study comparing sulphasalazine with placebo in rheumatoid factor (RF)-negative rheumatoid arthritis

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The efficacy and tolerability of sulphasalazine (SASP) was examined in a double blind, placebo-controlled 24-week study of 32 patients with rheumatoid factor (RF)-negative RA. Twelve patients (75%) of the SASP group completed the study; 4 patients were withdrawn because of an adverse event. Ten patients (62.5%) in the placebo group completed the study; 5 dropped out because of lack of response and one because of an adverse reaction.

Efficacy was demonstrated by a significant and sustained improvement in the indices of disease activity in the SASP group. It was confirmed by significant intergroup differences in favour of SASP over placebo in the changes in ESR, Ritchie index, number of painful joints and clinical score. There was also a significant difference in favour of SASP in the number of responders and the number of withdrawals due to inefficacy. The character, frequency and timing of side-effects were similar to those previously reported. All were reversible on stopping therapy.

This study shows that SASP is an effective second-line drug for treating patients with RF-negative RA.