Lebrikizumab maintains atopic dermatitis skin clearance for 1 year

Lebrikizumab monotherapy was efficacious in improving atopic dermatitis in 80% of patients at 1 year, according to results from two phase 3 trials announced by Eli Lilly and Company.

The 52-week, randomized, double-blind, placebo-controlled, parallel-group phase 3 ADvocate 1 and 2 trials randomly assigned patients to receive 500 mg of lebrikizumab — an investigational interleukin-13 inhibitor — initially and at 2 weeks, followed by 250 mg or placebo every 2 weeks during a 16-week treatment period.

After week 16, those who achieved a clinical response, defined as EASI75, were again randomly assigned to receive lebrikizumab every 2 or every 4 weeks or placebo for 36 additional weeks.

In the ADvocate 1 trial, 79% of patients who received lebrikizumab every 4 weeks and 79% of those who received the study drug every 2 weeks maintained EASI75 through 1 year. In the ADvocate 2 trials, 85% of those who received lebrikizumab every 4 weeks and 77% of those who received it every 2 weeks maintained EASI75.

“We believe this supports the potential of lebrikizumab to become a first-line biologic and may support less frequent dosing," Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Lilly, said in a press release. "We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval."

The company plans to submit a biologics license application to the FDA based on these data, while Almirall, which has a collaboration agreement with Eli Lilly for development in Europe, plans to submit to the European Medicines Agency for authorization.

“ADvocate 1 and 2 results add to the exciting growing body of evidence from our Phase 3 clinical trial program and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options. We look forward to continuing our collaboration with Lilly and advancing in our clinical program, aiming to obtain approval in the European Union," Karl Ziegelbauer, PhD, chief scientific officer at Almirall S.A., said in the release.