06 Jul Cutaneous Lupus Erythematosus: Biogen’s Study of Investigational Monoclonal Antibody Shows Promise

MedicalResearch.com Interview with:

Dr. Franchimont

Nathalie Franchimont, M.D., Ph.D.
Vice President
Multiple Sclerosis and Immunology Development Unit
Biogen

MedicalResearch.com: What is the background for this study?

Response: BIIB059 is an investigational fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells (pDCs), a protein present in specific cells within the immune system. An antibody against BDCA2 may potentially interrupt production of interferons, which are inflammatory molecules that are increased in patients with lupus and thought to contribute to disease activity.

The LILAC study is two-part, Phase 2, randomized, double-blind trial investigating the efficacy and safety of BIIB059 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). Data from the CLE portion of the study were recently presented at the European E-Congress of Rheumatology (EULAR) 2020, which was held virtually from June 3-6, 2020.

Overall, study participants with CLE who received BIIB059 demonstrated statistically significant reduction of disease activity compared to those who received placebo, as assessed by the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score. The results were encouraging and it warrants continued evaluation of BIIB059 in patients with CLE.

Cutaneous lupus erythematosus is a chronic autoimmune disease wherein the body’s immune system attacks healthy skin, often causing rashes and skin lesions which can be painful or itchy. There is substantial unmet medical need for people with lupus given the limited number of treatment options available to manage this difficult-to-treat and chronic disease.

Ultimately, we are motivated by the possibility of bringing potential new treatment options to lupus patients in need.

MedicalResearch.com: What are the main findings?

Response: The CLE part of the LILAC study met its primary endpoint (p<0.001) by demonstrating a dose response of BIIB059 on the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 16 in patients with CLE.

Study participants with CLE that received 50 mg, 150 mg and 450 mg of BIIB059 subcutaneously every 4 weeks (Q4W) with a loading dose at week 2 experienced reductions in CLASI-A scores of 38.8 percent (p=0.015), 47.9 percent (p<0.001) and 42.5 percent (p=0.001), respectively, versus 14.5 percent with placebo. With respect to the secondary endpoint of CLASI-50 response, statistical significance was achieved in study participants who received 450 mg of BIIB059; 23.3 percent (p=0.024) more participants achieved CLASI-50 response versus placebo. While not statistically significant, more participants treated with BIIB059 50 mg (15.8 percent) and 150 mg (21.2 percent) achieved a CLASI-50 response versus placebo. A CLASI-50 response is defined as a 50 percent improvement from baseline in CLASI-A score.

The majority of adverse events in the LILAC study were mild or moderate. The incidence of serious adverse events were 7.1 percent versus 9.1 percent in participants that received BIIB059 compared to placebo, respectively. Rate of infections was 34.3 percent versus 30.3 percent in participants that received BIIB059 versus those given placebo; no significant increased risk of infection has been identified. Eight participants, who all received BIIB059, discontinued study drug due to side effects. 

MedicalResearch.com: What should readers take away from your report?

Response: As mentioned earlier, there are limited treatment options for patients with cutaneous lupus erythematosus so the data presented at EULAR are potentially promising for the community. It’s an exciting step in the evaluation of BIIB059, so I’m proud to be part of the team that has played a role in bringing forth this critical research.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: The cutaneous lupus erythematosus results from this study are encouraging in that further investigation is warranted. As a next step, we plan to initiate a Phase 3 study to further evaluate the efficacy and safety of BIIB059.

MedicalResearch.com: Is there anything else you would like to add?

Response: Our team is looking forward to sharing results from the SLE part of the LILAC study at a future medical congress.

Citation:

A HUMANIZED MONOCLONAL ANTIBODY TARGETING BDCA2 ON PLASMACYTOID DENDRITIC CELLS , SHOWS DOSE-RELATED EFFICACY IN THE PHASE 2 LILAC STUDY IN PATIENTS WITH ACTIVE CUTANEOUS LUPUS ERYTHEMATOSUS 

BIIB059 Phase 2 lupus study presented at the 2020 virtual EULAR congress,

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Last Updated on July 6, 2020 by Marie Benz MD FAAD