Phase III trial into lebrikizumab shows positive results for atopic dermatitis patients
pharmafile | January 10, 2022 | News story | Sales and Marketing |
Almirall has reported positive results from their Phase III trial into lebrikizumab, which demonstrated significant improvement and itch relief when combined with topical corticosteroids in atomic dermatitis patients.
By Week 16, the study met all primary and secondary endpoints for patients on the lebrikizumab combination arm.
Lebrikizumab is a novel, investigational monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life, and blocks IL-13 signaling. In people with AD, the IL-13 protein – an important pathogen mediator in the disease – is overexpressed. This leads to an upsurge in multiple AD symptoms by causing T-helper type 2 (Th2) cell inflammation, and resulting in skin barrier dysfunction, itch, infection, and hard areas of skin.
The primary endpoints were 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 a 75 percent change from baseline in their Eczema Area and Severity Index (EASI) score, both at week 16.
The treatment, in combination with TCS, also achieved key secondary endpoints versus placebo in patients with AD, including skin improvement, itch relief, improvement in interference on sleep, and quality of life.
“The signs and symptoms of AD differ depending on the individual patient characteristics and depending on the severity can affect their sleep, social activities, and their overall wellbeing. Patients need effective and well tolerated treatment options that can provide long term disease control and an optimal quality of life,” said Dr med Andreas Pinter, Director of Clinical Research at the University Hospital in Frankfurt/Main (Germany) and one of the investigators of the ADhere trial.
“Lebrikizumab recently showed its potential efficacy in monotherapy. Now, the data from ADhere also demonstrated its effect on skin clearance and itch relief as part of a combination therapy, suggesting the medicine could become a new treatment option for this immune-mediated chronic skin disease.”