COMPARATIVE-STUDY OF TENIDAP, A CYTOKINE-MODULATING ANTIRHEUMATIC DRUG, AND DICLOFENAC IN RHEUMATOID-ARTHRITIS - A 24-WEEK ANALYSIS OF A 1-YEAR CLINICAL-TRIAL

Tenidap is a novel anti-rheumatic drug that combines cytokine modulati on with cyclo-oxygenase inhibition. This 24-week, multicentre, double- blind, randomized study compared the clinical efficacy, biochemical ef fects and safety of tenidap 120 mg/day (once daily) with diclofenac 15 0 mg/day (50 mg t.i.d.) in the treatment of 384 patients with active r heumatoid arthritis. After 24 weeks, improvement with tenidap was sign ificantly greater than with diclofenac for all five primary efficacy p arameters, two of the four secondary efficacy parameters and 11 of the 13 Arthritis Impact Measurement Scales assessments. The superior effi cacy of tenidap was apparent after 4 weeks of treatment with further i mprovements observed by 24 weeks. The probability of discontinuation d ue to lack of efficacy was significantly greater in the diclofenac gro up. Tenidap but not diclofenac was associated with significant, rapid and sustained reductions in C-reactive protein and serum amyloid A lev els and with a significant reduction in plasma interleukin-6. The natu re and frequency of side-effects were similar in the two groups as was the discontinuation rate for treatment-related safety reasons. Tenida p was associated with an equal incidence of elevated transaminases, bu t a higher incidence of mild (greater than or equal to 500 mg/24 h < 1 500 mg/24 h) non-progressive, proteinuria of proximal tubular origin c ompared with diclofenac.