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Data from the ADhere studies found that lebrikizumab was well tolerated in patients with atopic dermatitis.
New data from the ADvocate program found that patients with atopic dermatitis who were treated with lebrikizumab monotherapy experienced a 75% reduction in disease severity at 16 weeks of the study.
The findings were presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston. Compared to placebo, treatment with the IL-13 inhibitor resulted in clinically meaningful improvements in itch and other patient reported outcomes.
The ADvocate 1 trial saw that 43% of patients who received lebrikizumab had achieved clear or almost clear skin (IGA) at 16 weeks. Among patients treated with the therapy, 59% achieved an EASI-75 response.
For ADvocate 2, 33% of patients taking lebrikizumab achieved clear or almost clear skin at 16 weeks, and 51% achieved an EASI-75 response.
“Patients seek medicines that provide effective and well tolerated treatment options that can address those symptoms and improve their quality of life,” said Diamant Thaçi, PhD, Director at the Comprehensive Center for Inflammation Medicine at the University of Lübeck in Germany and principal investigator of the ADvocate 2 trial. “The observed efficacy of lebrikizumab in these studies confirms the potential of this novel treatment, which would be a well-received addition to the atopic dermatitis armamentarium.”
The safety profile of lebrikizumab was consistent with prior studies of the drug in atopic dermatitis, and adverse events were considered mild or moderate in severity and did not result in treatment discontinuation.
Common adverse events across both trials included conjunctivitis (7% and 8%, respectively), common cold (nasopharyngitis) (4% and 5%, respectively) and headache (3% and 5%, respectively).
According to a press release, data on the 52 week results from both trials and ADhere- a phase 3 study of lebrikizumab with topical steroids – will be issued in the coming months.
Additionally, Almirall and Eli Lilly intend to submit filings to regulatory authorities around the world by the end of 2022 after the ADvocate studies are completed.
“We look forward to sharing longer term results from ADvocate 1 and 2 this year, which we believe will further highlight that lebrikizumab can provide much needed relief for people who struggle from this chronic, and many times, life-long disease,” said Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Lilly.