Melinda Gooderham, MSc, MD, FRCPC: Insights Into Lebrikizumab’s Sustained 3-Year Efficacy

“It's really great to have 3-year data when a drug is first approved. Normally, when we get a drug approval, the drug is fairly new; we don't have that much long-term efficacy and safety data. With lebrikizumab, we already have at the time of approval, the presentation of 3-year efficacy and safety data,” said Melinda Gooderham, MSc, MD, FRCPC, in an interview with Dermatology Times. “I think that will give confidence to patients and prescribers who are considering this medication for their patients with moderate to severe atopic dermatitis.”

A poster presentation at the 33rd European Academy of Dermatology and Venereology (EADV) Congress held September 25 through 28 in Amsterdam, Netherlands, detailed the results of the ADjoin long-term extension trial (NCT04392154) evaluating the 3-year safety and efficacy data of lebrikizumab (Ebglyss; Eli Lilly and Company) for the treatment of patients with moderate to severe atopic dermatitis.¹ Recently, lebrikizumab was approved by the FDA on September 13, 2024, for patients aged 12 years and older.²

Gooderham, study author, ADvocate investigator, and medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, Canada, reviewed the patients who were candidates for the long-term extension trial, how lebrikizumab’s 3-year data further supports its recent FDA-approval, the unique mechanism of action of lebrikizumab, and how lebrikizumab can benefit younger patients as an injection compared to a daily topical.

In ADvocate 1 and 2, adult patients aged 18 years and old and adolescent patients aged 12 years and older were randomized 2:1 to receive lebrikizumab 250mg every 2 weeks with a 500mg loading dose at baseline a week 2, or placebo. After week 16, patients who received lebrikizumab 250mg every 2 weeks and who achieved EASI 75 or an IGA score of 0 or 1 with a ≥2-point improvement from baseline without rescue medication, were randomized 2:2:1 to receive lebrikizumab 250mg every 2 weeks (LEBQ2W), lebrikizumab 250mg every 4 weeks (LEBQ4Q), or placebo (lebrikizumab withdrawal).¹

Patients who then completed week 52 of the ADvocate trials were eligible to enroll in the ADjoin long-term extension trial and receive the same treatment regimen as in the maintenance period of ADvocate1 & 2. Efficacy data was assessed through week 100 of ADjoin using IGA 0 or 1 and EASI 75. Safety data was reported from ADjoin enrollment up to April 24, 2024.¹

In total, 291 patients in ADvocate 1 & 2 achieved EASI 75 or IGA 0/1 at week 16 and entered the maintenance period until week 52. Of those patients, 82 (LEBQ2W) and 99 (LEBQ4W) patients entered ADjoin, and 76.8% (n=63) and 71.7% (n=71) completed week 100 of ADjoin (152 weeks of continuous LEB treatment).¹

Key results include:

• Among patients with an IGA 0/1 at week 16 in the LEBQ2W and LEBQ4W arms, 82.9% and 84.0% of patients maintained an IGA 0/1 at week 152, respectively
• Among patients who achieved EASI 75 at week 16 in the LEBQ2W and LEBQ4W arms, 90.5% and 94.1% of patients maintained EASI 75 at week 152, respectively
• Among patients who achieved EASI 75 at week 16 in the LEBQ2W and LEBQ4W arms, 79.4% and 86.8% of patients achieved EASI 90 by week 152, respectively

“The majority of patients maintained clear or almost clear skin over 152 weeks of continuous lebrikizumab treatment in both the LEBQ2W and LEBQ4W arms. The lebrikizumab safety profile was consistent with that of previous lebrikizumab studies in patients with moderate to severe AD,” concluded the study authors.¹

References

1. Thaci D, Irvine A, Simpson E, et al. Efficacy and Safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial. Poster presented at: 33rd European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, Netherlands.
2. FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed September 27, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with