Résumé
Objective. To determine the efficacy and the safety of IX 207‐887 treatment in rheumatoid arthritis. The IX compound [10‐methoxy‐4H‐benzo(4,5)cyclohepta‐(1,2‐b)thiophene‐4‐yliden acetic acid] is effective in several animal models of rheumatoid arthritis and has a mechanism of action involving the inhibition of interleukin‐1 release. Methods. A double‐blind, controlled trial of 16 weeks' duration comparing placebo with IX at a daily dosage of 800 mg or 1,200 mg (20 patients/group) was conducted. Results. Thirteen patients withdrew from the study, 3 because of lack of efficacy (all in the placebo group) and 10 because of side effects (1 in the placebo group [skin rash] and 9 in the IX groups [skin rash in 5, intestinal disturbances in 2, hepatitis in 1, meningitis in 1]). Intent‐to‐treat analysis showed a statistically significant difference in the variations of clinical and laboratory parameters between the 3 groups. Between‐group comparisons showed an improvement in all these variables in the IX groups versus the placebo group. According to Paulus' criteria, 2 of the 20 placebo‐treated patients (10%), 9 of the 20 IX 800 mg–treated patients (45%), and 11 of the 20 IX 1,200 mg–treated patients (55%) were considered responders ( P = 0.008). Conclusion. The findings of this study suggest that the tolerability of IX is acceptable in rheumatoid arthritis patients, and that IX is an effective slow‐acting drug for use in rheumatoid arthritis.