Eli Lilly and Almirall’s lebrikizumab has been associated with sustained improvements in the signs and symptoms of atopic dermatitis, according to the first readout from a long-term extension (LTE) study of the IL-13 inhibitor.
Atopic dermatitis, or atopic eczema, is a chronic, inflammatory disease of the skin that causes inflammation, redness and irritation of the skin.
The ADjoin LTE has been evaluating a 250mg injection of lebrikizumab every two weeks or monthly in patients who had already seen clinical benefits after 16 weeks in the late-stage ADvocate 1, ADvocate 2 or ADhere trials.
Results from ADjoin show that Lebrikizumab provided durable efficacy in skin and itch outcomes in both dosing groups for up to two years of treatment.
Of the patients who moved from the ADvocate trials and received a monthly dose of lebrikizumab, 76% were assessed as having clear or almost clear skin after two years, compared with 86% of those who received a dose every two weeks.
Similar results were seen with patients who moved from the ADhere trial, with 79% of those in the monthly dosing group and 84% in the two-week dosing group achieving clear or almost clear skin after two years.
The safety profile of lebrikizumab in ADjoin was consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed, the companies said.
Lotus Mallbris, senior vice president of global immunology development and medical affairs at Lilly, said: “Results from ADjoin reinforce the strong efficacy and safety profile of lebrikizumab seen in the other phase 3 atopic dermatitis trials.
“This data also furthers our understanding of the long-lasting benefits of lebrikizumab as a potential first-line biologic treatment for patients.”
Lilly has exclusive rights for the development and commercialisation of lebrikizumab in the US and the rest of the world outside Europe, while Almirall has licensed the rights for the treatment of dermatology indications in Europe.
Last month, Almirall announced that lebrikizumab had been recommended by the European Medicines Agency’s human medicines committee to treat moderate-to-severe atopic dermatitis.
The Committee for Medicinal Products for Human Use has specifically recommended approval for the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy.