Almirall and Eli Lilly’s lebrikizumab has been associated with stable and long-lasting improvements in atopic dermatitis, according to new secondary data from the phase 3 trials investigating the drug.
Typically referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting up to 4.4% of adults in the EU.
The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck.
The identically designed ADvocate1 and ADvocate2 trials evaluated the efficacy and safety of lebrikizumab as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis versus placebo.
A post-hoc analysis based on data from the two studies’ 16-week induction periods in addition to the 16-week ADhere study, which evaluated the drug in combination with topical corticosteroids, showed that up 73% of patients treated with lebrikizumab experienced improvement or clearance of face or hand dermatitis.
Additionally, 80% of patients treated with lebrikizumab in ADvocate 1 and 2 maintained an improvement of at least 75% in lesion extent and severity (EASI-75) at 52 weeks after achieving EASI-75 at 16 weeks.
More than 70% maintained EASI-75 response with no or minimal fluctuations across ten study visits through 52 weeks of treatment, the companies said, and results were similar when dosed once every four weeks or once every two weeks.
Almirall has licensed the rights to develop and commercialise lebrikizumab for use as a treatment of dermatology indications, including atopic dermatitis, in Europe, while Lilly has exclusive rights for the development and commercialisation of lebrikizumab in the US and the rest of the world.
The two companies said they expect regulatory decisions in the EU and US later this year.
Karl Ziegelbauer, chief scientific officer at Almirall, said: “Based on the lasting response seen in patients, including those with traditionally challenging areas like the face and hands, we anticipate that lebrikizumab may become a first-line treatment option for people living with atopic dermatitis and their healthcare professionals.”
Lotus Mallbris, senior vice president of global immunology development and medical affairs at Lilly, said: “This novel data adds to the robust body of evidence on lebrikizumab to date and further represents our commitment to setting new expectations for people living with atopic dermatitis. We look forward to regulatory decisions later this year.”