Today, Eli Lilly and Company announced results for its third global phase 3 study on the interleukin (IL)-13 inhibitor lebrikizumab, in which it significantly improved disease severity when combined with topical corticosteroids in people with moderate-to-severe atopic dermatitis/
Data from the Adhere study confirmed that by week 16, all primary and key secondary endpoints for patients on lebrikizumab were met.
The primary endpoints were Investigator Global Assessment (IGA) score of clear or almost clear skin with a reduction of at least 2 points from baseline, in addition to at least a 75% change from baseline in the Eczema Area and Severity Index (EASI) score at week 16.
HCPLive reported on top-line data from the ADvocate 1 and ADvocate 2 trials in August, when lebrikizumab met primary and all key secondary endpoints as a monotherapy including itch, interference, of itch on sleep and quality of life at week 16.
"These results add to the growing body of evidence from our robust Phase 3 clinical trial program for lebrikizumab and support the hypothesis that targeting the IL-13 pathway is critical in treating AD and helping improve outcomes for these patients,” said Loutus Mallbirs, MD, PhD, vice president of global immunology development and U.S. and global medical affairs at Lilly.
“We look forward to continuing to evaluate lebrikizumab's clinical utility in the ongoing studies in the hopes of making this medicine available to those who still have unmet needs."
Additional data analyses from Adhere and from the ADvocate 1 and ADvocate 2 phase 3 trials are planned for future scientific congresses in 2022, with US and EU regulatory submissions intended for next year pending successful completion of the monotherapy trials.