The effectiveness of Litifilimab in treating cutaneous lupus erythematosus
Reviewed by Dat Tien Nguyen, B.A, ScM. Posted on August 10th, 2022
Cutaneous lupus erythematosus (CLE) is an autoimmune disease in which the immune system attacks the host healthy keratinocyte. These damages are mediated by the cytopathic effect of cytotoxic T-cell and pro-inflammatory cytokines produced by plasmacytoid dendritic cells. Previous studies had found that there is a dose-response relationship between the severity of CLE and the degree of type I Interferon expression by plasmacytoid dendritic cells. A recent phase 2 clinical trial found that Litifilimab was effective at reducing skin disease activity
Litifilimab is a humanized IgG1 antibody. This antibody can bind to Blood Dendritic Cell Antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. This interaction inhibits the expression of type I Interferon and other pro-inflammatory cytokines. The study enrolled 132 participants and randomly assigned them to 4 groups to receive either placebo, or litifilimab at 50-mg, 150-mg, or 450-mg dosage. The placebo/treatment is administered subcutaneously at weeks 0, 2, 4, 8, and 12. CLE severity is assessed using the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity scale (CLASI-A) at baseline and throughout the clinical trial. After 16 weeks, those receiving 50-mg, 150-mg, and 450-mg of Litifilimab experienced a -38.8%, -47.9%, and -42.5% change from baseline respectively. This reduction in severity is more significant than those who had received placebo (-14.5%).
72% of those who had received Litifilimab reported adverse events; this is similar to the 65% in those who received placebo. Commonly reported adverse events include: nasopharyngitis, headache, and injection-site erythema. Due to the suppression of Interferon production, it is expected that those who received the treatment will be more susceptible to viral infection. 14% of those in the Litifilimab group reported viral infection in the form of: influenza, oral herpes, and other viral upper respiratory tract infection. Only 9% of those in the control group reported viral infection in the form of systemic infection and Herpes Simplex infection.
Litifilimab is a humanized IgG1 antibody. This antibody can bind to Blood Dendritic Cell Antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. This interaction inhibits the expression of type I Interferon and other pro-inflammatory cytokines. The study enrolled 132 participants and randomly assigned them to 4 groups to receive either placebo, or litifilimab at 50-mg, 150-mg, or 450-mg dosage. The placebo/treatment is administered subcutaneously at weeks 0, 2, 4, 8, and 12. CLE severity is assessed using the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity scale (CLASI-A) at baseline and throughout the clinical trial. After 16 weeks, those receiving 50-mg, 150-mg, and 450-mg of Litifilimab experienced a -38.8%, -47.9%, and -42.5% change from baseline respectively. This reduction in severity is more significant than those who had received placebo (-14.5%).
72% of those who had received Litifilimab reported adverse events; this is similar to the 65% in those who received placebo. Commonly reported adverse events include: nasopharyngitis, headache, and injection-site erythema. Due to the suppression of Interferon production, it is expected that those who received the treatment will be more susceptible to viral infection. 14% of those in the Litifilimab group reported viral infection in the form of: influenza, oral herpes, and other viral upper respiratory tract infection. Only 9% of those in the control group reported viral infection in the form of systemic infection and Herpes Simplex infection.