PracticalDermatology

The atopic dermatitis (AD) pipeline is extensive, and Lilly and Almirall S.A.’s lebrikizumab, a high-affinity and potent IL-13 inhibitor, is one of the most promising agents making its way down the pike. Recently, an analysis of four studies showed that the results achieved with lebrikizumab in responders at 16 weeks are maintained with treatment every four weeks for up to one year in patients with moderate-to-severe AD with or without topical corticosteroids. Here, lead author Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, discusses the findings, which were presented at the 25th Annual World Congress of Dermatology in Singapore.

Why is this topic important to study?

Emma Guttman-Yassky, MD, PhD: Patients and doctors may like the flexibility of spacing out treatment to every four weeks and even longer if that is possible. This study shows that it is possible in most patients who achieved adequate control and clearance of AD. Further, in a subset of super-responders, we may be able to maintain them even after stopping the systemic drug.

Describe the research and your findings.

Dr. Guttman-Yassky: The study looks at maintenance treatment results of ADvocate1 and ADvocate2, phase 3 trials evaluating induction and maintenance treatment with lebrikizumab monotherapy in patients with moderate-to-severe AD, Adhere, which evaluated induction treatment with lebrikizumab plus topical corticosteroids in patients with moderate-to-severe AD, and ADjoin, a long-term extension of five lebrikizumab studies. Patients who were well-controlled by lebrikizumab at week 16 were evaluated for maintenance of response when taking lebrikizumab every two or four weeks or off-drug (in the mono-therapy trials) and every two and four weeks in the add-on topical corticosteroids studies.

The results showed maintenance of response throughout the follow-up period of up to one year regardless of the dosing regimen. Both every two weeks and every four weeks showed similar maintenance of response over time. Further, an appreciable number of patients achieving response at week 16 could also be maintained off lebrikizumab for the follow-up period.

What is the next step?

Dr. Guttman-Yassky: The next step is to understand both clinically and mechanistically who are the patients that can be maintained with lebrikizumab every four weeks.