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OM-8980

An Initial Review of its Pharmacology and Therapeutic Potential in Rheumatoid Arthritis

  • Drug Evaluation
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Summary

OM-8980 is a slow-acting antirheumatic drug (SAARD). It is a glycoprotein extract of Escherichia coli, with immunomodulatory properties (unrelated to endotoxin) that include effects on cell-mediated and humoral mechanisms. These effects may account for its efficacy in rheumatoid arthritis, although the precise mode of action of OM-8980 in this setting is unknown.

In several randomised double-blind comparative clinical trials in patients with rheumatoid arthritis of generally mild to moderate severity; oral administration of OM-8980 24 mg/day for 6 to 12 months was associated with significant improvements in clinical measures of the disease and reductions in nonsteroidal anti-inflammatory drug and/or corticosteroid use. OM-8980 was also well tolerated in clinical investigations; most adverse events were minor, transient, and mainly gastrointestinal in nature. The drug did not induce circulating autoanti-bodies or immune complexes. In 2 investigations, OM-8980 showed greater efficacy than placebo without intergroup differences in tolerability. Compared with other SAARDs, OM-8980 was as effective as auranofin or penicillamine and was better tolerated than either; however, dosages of the latter drugs did not exceed the lower dosage ranges used clinically. A comparative trial with methotrexate (which appears the most appropriate SAARD in this setting) is lacking.

The beneficial effects and favourable tolerability of OM-8980 were also maintained with long term (median 5 years) administration in a small noncomparative retrospective investigation. While this study provided evidence of sustained efficacy without significant adverse events, the final results of an ongoing prospective trial are awaited to confirm these findings.

Thus, although further studies are required to consolidate the clinical profile of OM-898C), preliminary data indicate a role for this drug as second-line therapy for rheumatoid arthritis where methotrexate is inappropriate. Furthermore, given its favourable tolerability demonstrated thus far, OM-8980 may find particular use during earlier stages of the disease where the adverse effects of some other SAARDs might preclude their use.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    David H. Peters & Karen L. Goa

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  1. David H. Peters
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  2. Karen L. Goa
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Additional information

Various sections of the manuscript reviewed by:

C. Bottex-Gauthier, Centre de Recherches du Service de Santé des Armées Emile Parde, Département de Biologie Cellulaire, Lyons, France; P.M. Brooks, The University of New South Wales, St Vincent’s Hospital, Darlinghurst, New South Wales, Australia; J. Clot, Centre Hospitalier et Universitaire de Montpellier, Hôpita1 Saint Eloi, Montpellier, France; D.J. Dequeker, Universitaire Ziekenhuizen Leuven, UZ Pellenberg - Rheumatologie, Lubbeek, Belgium; B.A. Dijkmans, University Hospital, Department of Rheumatology, Leiden, The Netherlands; E.V Hess, University of Cincinnati Medical Center, College of Medicine, Department of Internal Medicine, Division of Immunology, Cincinnati, Ohio, USA; R.J. Powell, Queen’s Medical Centre, Directorate of Medicine, University Hospital, Nottingham, England; T. Pullar, Dundee Teaching Hospitals, Ninewells Hospital and Medical School, Dundee, Scotland; D. Trentham, Division of Rheumatology, Beth Israel Hospital, Boston, Massachusetts, USA; T.L. Vischer, Division of Rheumatology, Department of Medicine, University Hospital of Geneva, Geneva, Switzerland; D. Willis, Department of Experimental Pathology, The Medical College of St Bartholomew’s Hospital, London, England.

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Peters, D.H., Goa, K.L. OM-8980. Clin Immunother 2, 65–77 (1994). https://doi.org/10.1007/BF03258523

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