A DOUBLE-BLIND CONTROLLED-STUDY COMPARING SULFASALAZINE WITH PLACEBO IN RHEUMATOID-FACTOR (RF)-NEGATIVE RHEUMATOID-ARTHRITIS

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 Twelve patients (75%) of the SASP group completed the study; 4 patients were withdrawn because of an adv erse event. Ten patients (62.5%) in the placebo group completed the st udy; 5 dropped out because of lack of response and one because of an a dverse reaction. Efficacy was demonstrated by a significant and sustai ned improvement in the indices of disease activity in the SASP group. It was confirmed by significant intergroup differences in favour of SA SP over placebo in the changes in ESR, Ritchie index, number of painfu l joints and clinical score. There was also a significant difference i n favour of SASP in the number of responders and the number of withdra wals due to inefficacy. The character, frequency and timing of side-ef fects were similar to those previously reported. All were reversible o n stopping therapy. This study shows that SASP is an effective second- line drug for treating patients with RF-negative RA.