Tenidap in rheumatoid arthritis a 24‐week double‐blind comparison with hydroxychloroquine‐plus‐piroxicam, and piroxicam alone

Abstract

Objective. To compare the clinical efficacy, effect on serum C-reactive protein (CRP), serum amyloid A (SAA), and plasma interleukin-6 (IL-6) levels, and safety of tenidap with a combination of hydroxychloroquineplus-piroxicam, and piroxicam alone, in the treatment of rheumatoid arthritis (RA) patients.Methods. A double-blind, randomized, multicenter study in which patients with active RA were treated with tenidap 120 mg/day, hydroxychloroquine 400 mglday and piroxicam 20 mglday, or piroxicam alone 20 mglday, for 24 weeks.Results. At weeks 12 and 24, tenidap produced greater improvements than piroxicam based on 5 primary efficacy parameters; this improvement showed statistical significance in 4 of the 5 measures at week 12, and in 3 of the 5 measures at week 24. Clinical improvements in the hydroxychloroquine-plus-piroxicamtreated patients were similar to those seen in patients treated with tenidap. Compared with piroxicam, tenidap was associated with significantly greater reductions in serum CRP concentrations at 4, 12, and 24 weeks, and significantly greater reductions in SAA concentrations at weeks 12 and 24. The decrease in SAA concentrations was also significantly greater at weeks 4 and 24 in the tenidap-treated group than in the hydroxychloroquine-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-piroxicam-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

Guidelines for the management of rheumatoid arthritis: 2002 Update

“…In the last decade, a number of studies have documented the symptomatic benefit of HCQ and SSZ, particularly for patients with early, milder disease (27)(28)(29)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63). Although HCQ alone does not slow radiologic damage, early treatment with HCQ has a significant impact on long-term patient outcome.…”

Finding a valid model for human Wegener's granulomatosis: Comment on the article by Tomer et al

“…In the earlier report, mice immunized with human ANCA were found to have glomerular IgG deposits suggestive of immune complex-mediated glomerulonephritis; yet, the authors do not describe this feature in the current article (1). The hallmark of glomerulonephritis in humans with W G is the absence of IgG deposits in the affected glomeruli (pauciimmune glomerulonephritis).…”

“…The same holds for our models that are induced by idiotypic dysregulation (1-4). In contrast to experimental systemic lupus erythematosus and antiphospholipid syndrome, which have been previously reported by us (2,3), in our 2 reports on the induction of mouse ANCA (1) and their characterization (current report), we were cautious enough not to include experimental W G in the titles because we were aware of the partial homology to the human condition.…”

“…We read with interest the report by Tomer et a1 on the characterization of mice that were induced to make antineutrophil cytoplasmic antibodies (ANCA) (1). In that report, mice immunized with human IgG ANCA generated antiidiotypic antibodies as well as anti-antiidiotypic antibodies (murine ANCA).…”

“…We read with interest the article by Blackburn et al describing the efficacy of tenidap in the treatment of rheumatoid arthritis (RA) (1). The authors state in the introduction that the mechanism of action of tenidap is mediated by its inhibition of cyclooxygenase and the modulation of the release of several cytokines, such as interleukin-1, tumor necrosis factor a, and interleukin-6.…”