A COMPARATIVE STUDY OF TENIDAP, A CYTOKINE-MODULATING ANTI-RHEUMATIC 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 cytokinemodulation with cyclo-oxygenase inhibition. This 24-week, multicentre,double-blind, randomized study compared the clinical efficacy,biochemical effects and safety of tenidap 120 mg/day (once daily)with diclofenac 150 mg/day (50 mg t.i.d.) in the treatment of384 patients with active rheumatoid arthritis. After 24 weeks,improvement with tenidap was significantly greater than withdiclofenac for all five primary efficacy parameters, two ofthe four secondary efficacy parameters and 11 of the 13 ArthritisImpact Measurement Scales assessments. The superior efficacyof tenidap was apparent after 4 weeks of treatment with furtherimprovements observed by 24 weeks. The probability of discontinuationdue to lack of efficacy was significantly greater in the diclofenacgroup. Tenidap but not diclofenac was associated with significant,rapid and sustained reductions in C-reactive protein and serumamyloid A levels and with a significant reduction in plasmainterleukin-6. The nature and frequency of side-effects weresimilar in the two groups as was the discontinuation rate fortreatment-related safety reasons. Tenidap was associated withan equal incidence of elevated transaminases, but a higher incidenceof mild (