Abstract
Objective:
To evaluate the safety and activity of an immunoconjugate of ricin A chain and anti-CD5 monoclonal antibody (anti-CD5 IC), with and without concomitant methotrexate and/or azathioprine, in the treatment of rheumatoid arthritis (RA).
Methods:
Seventy-nine patients with active RA were enrolled in 2 prospective open-label protocols.
Results:
Using composite criteria, response rates were 50-68% at 1 month and 22-25% at 6 months. Transient depletion of CD3/CD5 T cells was observed on days 2 and 5 of treatment, with reconstitution on day 15 or day 29. Treatment-associated adverse effects were common but resolved rapidly without sequelae.
Conclusion:
These findings suggest activity of anti-CD5 IC in active RA and warrant confirmation in a multicenter randomized study (currently underway).
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, Non-P.H.S.
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Adult
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Aged
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Antibodies, Monoclonal / therapeutic use
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Antigens, CD / analysis*
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Antigens, CD / immunology*
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Arthritis, Rheumatoid / drug therapy*
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Arthritis, Rheumatoid / immunology
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Azathioprine / adverse effects
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Azathioprine / therapeutic use*
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CD5 Antigens
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Cell Count
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Dose-Response Relationship, Drug
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Drug Therapy, Combination
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Female
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Humans
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Immunotoxins / adverse effects
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Immunotoxins / therapeutic use*
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Male
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Methotrexate / adverse effects
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Methotrexate / therapeutic use*
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Middle Aged
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Prospective Studies
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Ricin*
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T-Lymphocytes / immunology*
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Treatment Outcome
Substances
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Antibodies, Monoclonal
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Antigens, CD
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CD5 Antigens
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Immunotoxins
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Ricin
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Azathioprine
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Methotrexate