An early study of litifilimab, a humanized monoclonal antibody, has indicated it may be effective in the treatment of cutaneous lupus erythematosus (CLE), according to researchers from the University of Pennsylvania’s Perelman School of Medicine.
Llitifilimab targets the blood dendritic cell antigen 2 (BDCA2) receptor on plasmacytoid dendritic cells, leading to the downregulation of pro-inflammatory proteins believed to be involved with the inflammation associated with CLE.
Published in the New England Journal of Medicine, the 16-week LILAC study (Part B) included 132 participants and showed decreased CLE activity compared to placebo, the primary endpoint. Most improvements were seen at 12 to 16 weeks of treatment. The study assessed four dose groups (placebo (33 participants), 50 mg (26 participants), 150 mg (25 participants), or 450 mg (48 participants) administered subcutaneously at weeks 0, 2, 4, 8, and 12) in participants with active, histologically confirmed CLE.
“Some patients in our trial saw huge improvements within a month,” said the study's lead author Dr. Victoria Werth, a professor of Dermatology at Penn Medicine and the chief of Dermatology at the Corporal Michael J. Creszcenz VAMC, in a press release.
“CLE can cause scarring, atrophy in the skin, and skin discolouration, as well as permanent hair loss,” she said. “These impacts on physical appearance also affect mental and emotional health and well-being.”
According to Dr. Werth, one key to assessing the therapy’s effectiveness was the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A), a measurement tool Penn Medicine researchers helped develop. The tool permitted a more precise and accurate characterization of CLE activity in the study participants.
“Not only do the available drugs [for CLE] not always work, but they are also not always well tolerated,” Dr. Werth said in the press release. “Sometimes, a patient may have to move up to immunosuppressants, and those have a lot of side effects like higher risk of infection. So being able to develop a different approach could be pivotal.”
In the LILAC A and LILAC B studies, most adverse events related to litifilimab were rated as mild or moderate (≥5%) and included nasopharyngitis, headache, injection-site erythema, SLE, arthralgia, upper respiratory tract infection, influenza, pruritus, and cough.