The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody
| Autor: | Harvey Lui, Russell L. Dedrick, Neil H. Shear, Mark White, Kim A. Papp, Charles Lynde, Wayne Gulliver, Wayne Carey, Robert Bissonnette, Robert J. Bauer, David Gratton, Marvin Garovoy, Sun Sook Kim, James G. Krueger, Susan M. Kramer, Jerry Shapiro, Daniel Minier, Piyush M. Patel, Patricia A. Walicke, Jean P. Ouellet, Anna Magee |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
Male medicine.medical_specialty Efalizumab Dermatology Placebo Severity of Illness Index Gastroenterology Leukocyte Count Double-Blind Method Psoriasis Area and Severity Index Psoriasis Internal medicine White blood cell Severity of illness medicine Humans Lymphocyte Count Infusions Intravenous Adverse effect Aged Body surface area business.industry Antibodies Monoclonal Middle Aged medicine.disease Lymphocyte Function-Associated Antigen-1 Surgery Treatment Outcome medicine.anatomical_structure Female business medicine.drug |
| Zdroj: | Journal of the American Academy of Dermatology. 45:665-674 |
| ISSN: | 0190-9622 |
| DOI: | 10.1067/mjd.2001.117850 |
| Popis: | Anti-CD11a (hu1124) is a humanized monoclonal antibody directed against the CD11a subunit of LFA-1. This study investigated whether treatment with anti-CD11a antibody provides clinical benefit to patients with moderate to severe plaque psoriasis.This was a double-blind, placebo-controlled, phase II, multicenter study. In total, 145 patients with minimum Psoriasis Area and Severity Index scores of 12 and affected body surface area of 10% or more were sequentially enrolled into low-dose (0.1 mg/kg, n = 22) or high-dose (0.3 mg/kg, n = 75) groups. Within groups, patients were randomized to treatment or placebo (n = 48) in a 2:1 ratio. Drug was administered intravenously at weekly intervals for 8 weeks.The percentage of subjects achieving more than 50% improvement in physician's global assessment at day 56 (1 week after final dose) was 15% and 48% for placebo and 0.3 mg/kg of drug, respectively (P =.002). A physician's global assessment of excellent (75% improvement) was greater in the 0.3 mg/kg group versus placebo (25% vs 2%, P =.0003). Average Psoriasis Area and Severity Index scores at day 56 were 13.9 +/- 7.5 (placebo) and 10.9 +/- 8.4 (0.3 mg/kg) (P.0001). Epidermal thickness was reduced in the 0.3 mg/kg group compared with the placebo group (37% vs 19%, P =.004). Treatment was well tolerated; mild to moderate flu-like complaints were the most common adverse events. White blood cell counts and lymphocyte counts transiently increased. Depletion of circulating lymphocytes did not occur.Anti-CD11a antibody administered intravenously in 8 weekly doses of 0.3 mg/kg was well tolerated and induced clinical and histologic improvements in psoriasis. |
| Databáze: | OpenAIRE |
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