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Efficacy and safety of OM-8980 in patients with rheumatoid arthritis: An open-label, long-term, multicenter study



Efficacy and safety of OM-8980 in patients with rheumatoid arthritis: An open-label, long-term, multicenter study



Current Therapeutic Research 60(12): 638-649



This open-label, long-term, prospective study on the use of the bacterial extract OM-8980 in patients with rheumatoid arthritis (RA) was originally designed to last 1 year; however, at the request of both the patients and the investigators, it was continued for up to 6 years. Two hundred thirty-five patients were assessed, 62 of whom completed at least 5 years. All of the assessed clinical variables (duration of morning stiffness, pain, total joint index), erythrocyte sedimentation rate, and modified disease activity score showed significant and continuously increased improvements between study entry and the last recorded visit. Concomitant medication use related to RA also decreased markedly over time, whereas radiologic findings showed no major changes between the start and the end of the study. The efficacy assessments by both the patients and the investigators reflect the beneficial evolutions recorded throughout the study; at the last visit, treatment efficacy was rated as good or very good in 92 cases (87.6%) according to the investigators and in 83 cases (79.0%) according to the patients. Thirty-nine patients (16.6%) reported 81 adverse events, mainly gastrointestinal in origin; OM-8980 was questionably or likely the cause of one third of these events. Results of this study suggest that OM-8980 can be administered for several years with continuous beneficial therapeutic effect, without the occurrence of major side effects.

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Accession: 010569018

Download citation: RISBibTeXText

DOI: 10.1016/s0011-393x(99)90002-4



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