✦ LIBER ✦

Treatment of active refractory rheumatoid arthritis with humanized monoclonal antibody campath-1h administered by daily subcutaneous injection

✍ Scribed by Eric L. Matteson; David E. Yocum; E. William St. Clair; Antonio A. Achkar; Michael S. Thakor; Mary R. Jacobs; Anita E. Hays; Catherine K. Heitman; Jeffrey M. Johnston

Publisher: John Wiley and Sons
Year: 1995
Tongue: English
Weight: 659 KB
Volume: 38
Category: Article
ISSN: 0004-3591
DOI: 10.1002/art.1780380903

No coin nor oath required. For personal study only.

✦ Synopsis

Objective. To investigate the dose tolerance and potential clinical activity of a humanized antilymphocyte monoclonal antibody, CAMPATH-1H (ClH), in patients with active, refractory rheumatoid arthritis (RA).

Methods. Thirty adult patients with active, refractory RA were treated in an open-label, 3-center, dose-escalation study of subcutaneously injected C1H. Six patients were assigned to each of 5 dosage groups (0.3, 1.0, 3.0, 10.0 or 30.0 mg/day), and received 10 daily injections of C1H over a 12-day period.

Results. Side effects occurred primarily during the first 1-2 days of dosing, and included mild fever, chills, nausea, vomiting, headache, and, in a minority of patients, hypotension. All patients developed some discomfort at the injection site. Self-limited infections occurred in 5 patients during the 6-month study period. Peripheral blood lymphocyte counts fell promptly after initial dosing and recovered slowly, usually over 2-3 months. Serum antibodies to C1H developed in 54% of

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