Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis.

Abstract

BACKGROUND:

Reduction in lesional, activated T cells induces improvement in psoriatic plaques. Galiximab (IDEC-114), an IgG(1) anti-CD80 antibody, binds to CD80, a costimulatory molecule involved in T-cell activation.

OBJECTIVE:

A Phase I/II, multidose, multischedule, dose-finding study of galiximab to evaluate safety, pharmacokinetics, and clinical activity was conducted in 35 patients with moderate to severe plaque psoriasis.

METHODS:

Seven cohorts of five patients received galiximab intravenously on three different schedules at different dose levels.

RESULTS:

Adverse events (AEs) commonly occurred as mild and self-limiting. Improvements were observed in most cohorts without evidence of a dose response in Psoriasis Area and Severity Index (50% or greater reduction in PASI score in 40% of patients), Physician's Global Psoriasis Assessment (PGA rating of Good or above in 57% of patients), and Psoriasis Severity Scale (PSS, baseline mean of 7.6 decreased by Study Day 127 to 5.0). An association was observed between reduction in CD3(+) cell count in histologic studies and reduction in PASI score. No antibodies to galiximab were detected.

CONCLUSION:

Galiximab appears to be safe and well tolerated with preliminary evidence of clinical and histologic response.

• Authors: Alice B Gottlieb, Sewon Kang, Kenneth G Linden, Mark Lebwohl, Alan Menter, Ahsan A Abdulghani, Michael Goldfarb, Nicole Chieffo, Mark C Totoritis
• Journal: Clinical immunology (Orlando, Fla.) (Clin Immunol) Vol. 111 Issue 1 Pg. 28-37 (Apr 2004) ISSN: 1521-6616 [Print] United States
• PMID: 15093549 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antibodies, Monoclonal
• galiximab

Topics

• Adult
• Antibodies, Monoclonal (administration & dosage, adverse effects, pharmacokinetics)
• Drug Administration Schedule
• Female
• Humans
• Immunohistochemistry
• Injections, Intravenous
• Keratinocytes (metabolism, pathology)
• Male
• Middle Aged
• Psoriasis (drug therapy)
• Skin (immunology, metabolism, pathology)
• Treatment Outcome