TENIDAP IN RHEUMATOID-ARTHRITIS - A 24-WEEK DOUBLE-BLIND COMPARISON WITH HYDROXYCHLOROQUINE-PLUS-PIROXICAM, AND PIROXICAM ALONE

Objective. To compare the clinical efficacy, effect on serum C-reactiv e protein (CRP), serum amyloid A (SAA), and plasma interleukin-6 (IL-6 ) levels, and safety of tenidap with a combination of hydroxychloroqui ne-plus-piroxicam, and piroxicam alone, in the treatment of rheumatoid arthritis (RA) patients. Methods. A double-blind, randomized, multice nter study in which patients with active RA were treated with tenidap 120 mg/day, hydroxychloroquine 400 mg/day and piroxicam 20 mg/day, or piroxicam alone 20 mg/day, for 24 weeks. Results. At weeks 12 and 24, tenidap produced greater improvements than piroxicam based on 5 primar y efficacy parameters; this improvement showed statistical significanc e in 4 of the 5 measures at week 12, and in 3 of the 5 measures at wee k 24, Clinical improvements in the hydroxychlaroquine-plus-piroxicam-t reated patients were similar to those seen in patients treated with te nidap, Compared with piroxicam, tenidap was associated with significan tly greater reductions in serum CRP concentrations at 4, 12, and 24 we eks, and significantly greater reductions in SAA concentrations at wee ks 12 and 24, The decrease in SAA concentrations was also significantl y greater at weeks 4 and 24 in the tenidap-treated group than in the h ydroxychloroquine-plus-piroxicam-treated group. Significant reductions in plasma IL-6 levels were observed at weeks 4, 12, and 24 within the tenidap group, and at week 24 within the hydroxychloroquine-plus-piro xicam-treated group. The overall occurrence of side effects, including gastrointestinal side effects, was similar in all 3 treatment groups. A small proportion of tenidap-treated patients (6.4%) manifested mild , nonprogressive, reversible proteinuria of presumed renal proximal tu bular origin, and 3-4% of patients had elevated transaminase levels, C onclusion. In the treatment of patients with RA, tenidap is as effecti ve as the combination of hydroxychloroquine-plus-piroxicam , and is mo re effective than piroxicam alone; moreover, tenidap's safety profile is comparable to that observed with piroxicam alone, and with hydroxyc hloroquine-plus-piroxicam. The clinical response observed in this stud y, as well as the prompt decreases in acute-phase protein levels of CR P and SAA, and in plasma IL-6 levels, suggest that tenidap represents a new type of antiarthritic medication, with properties similar to, bu t not identical to, a therapeutic combination of a nonsteroidal antiin flammatory drug with disease-modifying antirheumatic drugs.