Treatment of severe cutaneous lupus erythematosus with a chimeric CD4 monoclonal antibody, cM-T412

Background: Monoclonal CD4 antibodies are among the most potent immunomodulatory agents in various experimental models of autoimmune disease, including murine lupus erythematosus. Objective: The aim of this study was to evaluate the toxicity and therapeutic efficacy of a chimeric monoclonal CD4 antibody, cM-T412, in patients with cutaneous lupus erythematosus (LE). Methods: Five patients with severe cutaneous LE lesions received intravenously a total of 275, 400, or 475 mg of cM-T412 in single doses of 20 to 50 mg during a period of 5 to 8 weeks. Results: CD4 antibody treatment induced a long-lasting decrease in disease activity. It resulted in healing of LE skin lesions, a reconstituted responsiveness to conventional treatment, or both. Despite a substantial depletion of circulating CD4(+) T lymphocytes, no clinical signs of immunosuppression were noted. Conclusion: Monoclonal CD4 antibodies should be considered as a novel treatment for the management of severe cutaneous LE.