Clinical and histologic response to single-dose treatment of moderate to severe psoriasis with an anti-CD80 monoclonal antibody

Pathologic T-cell activation is implicated in psoriasis progression. CD80, a costimulatory molecule involved in T-cell activation, likely plays a key role. IDEC-114, an IgG1 anti-CD80 antibody, was evaluated for safety, pharmacokinetics, and preliminary clinical activity in this open-label, single-d...

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Bibliographic Details
Published in:Journal of the American Academy of Dermatology 2002-11, Vol.47 (5), p.692-700
Main Authors: Gottlieb, Alice B., Lebwohl, Mark, Totoritis, Mark C., Abdulghani, Ahsan A., Shuey, Steve R., Romano, Patricia, Chaudhari, Umesh, Allen, Roberta S., Lizambri, Richard G.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - pharmacokinetics
Antibodies, Monoclonal - therapeutic use
Antineoplastic agents
Biological and medical sciences
Chronic Disease
Dermatology
Female
Humans
Immunotherapy
Infusions, Intravenous
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Psoriasis - drug therapy
Psoriasis - pathology
Psoriasis. Parapsoriasis. Lichen
Severity of Illness Index
Treatment Outcome
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Summary:Pathologic T-cell activation is implicated in psoriasis progression. CD80, a costimulatory molecule involved in T-cell activation, likely plays a key role. IDEC-114, an IgG1 anti-CD80 antibody, was evaluated for safety, pharmacokinetics, and preliminary clinical activity in this open-label, single-dose, dose-escalating study in patients with moderate to severe chronic plaque psoriasis. Twenty-four patients received IDEC-114 (0.05 mg/kg, 0.25 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg, or 15 mg/kg). Psoriasis Area and Severity Index, Physician's Global Psoriasis Assessment, and Psoriasis Severity Scale scores improved in the highest-dose groups. Average plaque thickness and plaque CD3+ and CD8+ T-cell counts decreased in the 10 mg/kg dose group. Adverse events were primarily mild, transient, constitutional symptoms; the most common related events were mild asthenia (29% of patients), chills (25%), and headache (21%). The serum half-life of IDEC-114 was approximately 13 days. A single dose of IDEC-114 appears to be safe and well tolerated and has promising clinical activity in psoriasis. (J Am Acad Dermatol 2002;47:692-700.)
ISSN:0190-9622
1097-6787
DOI:10.1067/mjd.2002.124698