OM-8980 and D-penicillamine in the treatment of rheumatoid arthritis. A 12-month double-blind randomized study.
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.
Verstraeten
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Department of Internal Medicine, K.U. Leuven, Pellenberg, Belgium.
Sileghem
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Dequeker
J
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D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000942:Antigens, Bacterial; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000628:therapy; D016009:Chi-Square Distribution; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010396:Penicillamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
D000276:Adjuvants, Immunologic; D000942:Antigens, Bacterial; D003692:Delayed-Action Preparations; C050501:OM 89; D010396:Penicillamine