OM-8980 and D-Penicillamine in the Treatment of Rheumatoid Arthritis:A 12-Month Double-blind Randomized Study

Abstract

Forty patients with active rheumatoid arthritis were included in this monocentre double-blind study comparing the therapeutic efficacy and safety of the immunomodulator OM-8980 with that of D-penicillamine. After 12 months of treatment, the parameters of Ritchie index, duration of morning stiffness, pain assessed by a visual analogue scale and categories, number of swollen joints, grip strength and erythrocyte sedimentation rate (ESR) were all significantly improved with OM-8980, as was the case for the Ritchie index, number of swollen joints and ESR with D-penicillamine. Significant intergroup differences were recorded for pain categories in favour of OM-8980 and for the Ritchie index and number of swollen joints in favour of D-penicillamine. The need for concomitant anti-inflammatory therapies and the assessment of efficacy by physicians and patients did not differ significantly between the two groups. OM-8980 was significantly better tolerated than D-penicillamine (5 patients with 5 side effects as compared with 12 patients with 16 side effects). OM-8980 can thus be regarded as an efficient and well-tolerated slow-acting drug for the treatment of rheumatoid arthritis.

Rheumatoid arthritis and enteric bacteria

“…In addition, Evans et at. Several controlled clinical studies on patients with RA have shown that an extract of E. coti given orally (OM-8980, Subreum | has a disease controlling effect [121][122][123][124][125]. Escherichia coli GroEL stress protein belongs to the hsp60 family, together with the structurally related mycobacterial hsp65 showing cross-reactivity with many bacteria [ 120].…”

Om-8980

“…The clinical efficacy of OM-8980 24 mg/day was shown to be comparable to that of penicillamine 500 mg/day (maintenance dosage) in a small (n = 34) single-centre study of 12 months' duration (table 11), [24] although further comparisons should also be made with a higher titrated penicillamine dosage (~ 750 mg/day). NSAID/corticosteroid use and global evaluation of efficacy were similar for both groups.…”

“…At final evaluation, reductions in Ritchie index, the number of swollen joints, duration of morning stiffness, pain and ESR, and increased grip strength were accompanied by a decrease in NSAID/corticosteroid use (table 11). [23,24] In 2 placebo-controlled trials, improvements were greater for patients treated with OM-8980, although intergroup differences did not always attain statistical significance (table II). [23,24] In 2 placebo-controlled trials, improvements were greater for patients treated with OM-8980, although intergroup differences did not always attain statistical significance (table II).…”

“…The clinical efficacy of orally administered OM-8980 has been evaluated principally in a small series of parallel-group clinical trials which included 2 dose-ranging studies 121 ,22] and comparisons with placebo,12,18] auranofin [23] or penicillamine [24] (table II). The long term efficacy of the drug has also been studied in a noncomparative retrospective investigation.…”

Dendritic cells and the promise of antigen-specific therapy in rheumatoid arthritis

“…Oral lyophilised E. coli extract contains several bacterial heat shock proteins with immunomodulatory properties. The extract's clinical efficacy was equivalent to D -penicillamine in a placebo-controlled trial [50]. However, this extract is more likely to be a nonspecific immunomodulator than to induce antigen-specific tolerance.…”