Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials
Patients treated with the investigational IL-13 inhibitor also maintained itch relief across the two trials over the one-year period.
Fully 80 percent of lebrikizumab responders maintained improvements in skin clearance and atopic dermatitis disease severity at 52 weeks with once every two week and once every four week maintenance dosing, according to topline results from the Phase 3 clinical trials (ADvocate 1 and 2).
Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period.
With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lebrikizumab in AD in the second half of 2022, followed by submissions to other regulatory agencies around the world. Almirall also plans to submit these results this year to the European Medicines Agency (EMA) for authorization.
"Atopic dermatitis is a complex disease that requires personalized treatment approaches, including flexible dosing options for patients. In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at one year. We believe this supports the potential of lebrikizumab to become a first-line biologic and may support less frequent dosing," says Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly, in a news 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."
In ADvocate 1, 79 percent of patients who received lebrikizumab every four weeks and 79 percemt of patients who received lebrikizumab every two weeks maintained 75 percent or greater skin improvement (EASI-75) at one year of treatment. Additionally, 85 percent of patients who received lebrikizumab every four weeks and 77 percent of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 at one year of treatment.
The frequency of adverse events and the overall safety profile among these patients treated with lebrikizumab were consistent with the induction phase of the trials as well as previous lebrikizumab studies in AD. No new safety signals were observed in this patient population.
"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," states Karl Ziegelbauer, Ph.D., Almirall S.A.'s Chief Scientific Officer.
These studies are part of the comprehensive clinical development program for lebrikizumab in AD evaluating more than 2,000 patients. Full one-year results from the Phase 3 monotherapy studies will be disclosed at upcoming congresses and in publications in 2022. Additional Phase 3 clinical trials are enrolling for lebrikizumab in AD.
Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
About ADvocate 1 and ADvocate 2 and the Phase 3 Program
ADvocate 1 and ADvocate 2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD. During the 16-week treatment period, patients received lebrikizumab 500-mg initially and at two weeks, followed by lebrikizumab 250-mg or placebo every two weeks. In the maintenance period, patients with moderate-to-severe AD who achieved a clinical response after 16 weeks of lebrikizumab treatment were re-randomized to receive lebrikizumab every two weeks or four weeks or placebo for an additional 36 weeks. Patients who required rescue treatment during the induction period or who did not achieve clinical response (lebrikizumab non-responders) at 16 weeks received lebrikizumab every two weeks for an additional 36 weeks. The primary endpoints were measured by an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least 75 percent change in baseline in the Eczema Area and Severity Index (EASI-75) score at 16 weeks. EASI measures extent and severity of the disease. Key secondary endpoints were measured by IGA, EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus and the Dermatology Life Quality Index.
The U.S. Food and Drug Administration (FDA) granted lebrikizumab Fast Track designation in AD in December 2019. The lebrikizumab Phase 3 program consists of five key global studies including two monotherapy studies, a combination study (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Lilly has also initiated a first-of-its-kind clinical study dedicated to people of color living with AD. The study will further evaluate the efficacy and safety of lebrikizumab in people of color to generate additional data and disease information to help investigators and clinicians provide better diagnoses and treatment options.