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


CONCLUSIONS
Galiximab appears to be safe and well tolerated with preliminary evidence of clinical and histologic response.
Gottlieb
Alice B
AB
Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA. gottliab@umdnj.edu
Kang
Sewon
S
Linden
Kenneth G
KG
Lebwohl
Mark
M
Menter
Alan
A
Abdulghani
Ahsan A
AA
Goldfarb
Michael
M
Chieffo
Nicole
N
Totoritis
Mark C
MC
D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D007275:Injections, Intravenous; D015603:Keratinocytes / Q000378:metabolism / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012867:Skin / Q000276:immunology / Q000378:metabolism / Q000473:pathology*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; C437823:galiximab