Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis.
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Gottlieb AB, Kang S, Linden KG, Lebwohl M, Menter A, Abdulghani AA, Goldfarb M, Chieffo N, Totoritis MC
Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis.
Clin Immunol. 2004 Apr;111(1):28-37.
- PubMed ID
- 15093549 [ View in PubMed]
- 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.
DrugBank Data that Cites this Article
- Drug Targets
Drug Target Kind Organism Pharmacological Action Actions Galiximab T-lymphocyte activation antigen CD80 Protein Humans YesAntibodyDetails