Litifilimab (BIIB059), a Promising Investigational Drug for Cutaneous Lupus Erythematosus
Expert Opin Investig Drugs 2023;15:1-9 doi 10.1080/13543784.2023.2212154
Cho, et al. discuss the current challenges in the approval of CLE drugs and suggest outcome measures that could streamline the process. They also discuss the pharmacodynamics of litifilimab and the current status of clinical trials.
The FDA has not approved any therapies for the treatment of cutaneous lupus erythematosus (CLE) in the USA. Existing frameworks for identifying treatments focus on SLE patients with CLE, which is not representative of all CLE patients. The phase 2 LILAC study is the first clinical trial to use the skin-directed outcome measure CLASI for CLE, which showed litifilimab to have greater efficacy than placebo.