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HuMax-CD4: a fully human monoclonal anti-CD4 antibody for the treatment of psoriasis vulgaris.
- Source :
-
Archives of dermatology [Arch Dermatol] 2003 Nov; Vol. 139 (11), pp. 1433-9. - Publication Year :
- 2003
-
Abstract
- Background: Psoriasis is characterized by infiltration with mononuclear cells. Especially activated memory CD4+ T cells are critical in the pathogenesis. Interaction between the CD4 receptor and the major histocompatibility complex class II molecule is important for T-cell activation.<br />Objective: To test safety and efficacy of a fully human monoclonal anti-CD4 antibody (HuMax-CD4) in the treatment of psoriasis.<br />Design: Multicenter, double-blind, placebo-controlled, randomized clinical trial. Patients Eighty-five patients with moderate to severe psoriasis.<br />Interventions: Subcutaneous infusions of placebo or HuMax-CD4 at doses of 20, 80, 160, or 280 mg once weekly for 4 weeks.<br />Main Outcome Measures: Psoriasis Area and Severity Index (PASI), investigators' and patients' overall response assessment, adverse events, laboratory assessment including total T-cell and subtype counts, CD4 receptor occupancy, and interleukin 2 receptor levels.<br />Results: At week 7, mean PASI was reduced in all treatment groups (95% confidence intervals are in parentheses): placebo, 8% (-3% to 19%); 20 mg, 12% (-6% to 27%); 80 mg, 14% (-14% to 35%); 160 mg, 16% (-4% to 33%); and 280 mg, 24% (-10% to 48%). At the highest dose level, 6 (38%) of 16 patients obtained more than 25% reduction of PASI and 3 (19%) obtained more than 50% reduction of PASI. A dose-dependent decrease in total lymphocyte count was seen and was parallel to a dose-dependent decrease in CD4+ T cells. This decrease was due to a decrease in the memory subset, whereas the naive subset was affected to a minor degree. Four weeks of treatment with HuMax-CD4 was safe and well tolerated.<br />Conclusions: Treatment with HuMax-CD4 led to a moderate, not statistically significant reduction in PASI. The efficacy results obtained after only 4 weeks of treatment suggest that longer treatment would lead to even further reduction of PASI.
- Subjects :
- Adult
Aged
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal metabolism
CD4 Antigens metabolism
CD4 Lymphocyte Count
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Injections, Subcutaneous
Lymphocyte Count
Lymphocyte Subsets pathology
Male
Middle Aged
Placebos
Psoriasis pathology
Antibodies, Monoclonal therapeutic use
CD4 Antigens immunology
Psoriasis drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0003-987X
- Volume :
- 139
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Archives of dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 14623703
- Full Text :
- https://doi.org/10.1001/archderm.139.11.1433