https://doi.org/10.55788/f0963021
The recent EMA and FDA approval of lebrikizumab was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and adolescents (12 years and older) with moderate-to-severe AD [1,2]. Prof. Diamant Thaçi (University of Lübeck, Germany) presented the 3-year results of continuous lebrikizumab treatment in responders from the phase 3 ADvocate 1 and 2 studies [3].
Participants who completed week 52 of the parent trials were able to enrol in the long-term extension study ADjoin (NCT04392154) and received the same dose of lebrikizumab as in the maintenance phase of ADvocate 1 and 2. Response maintenance was evaluated for the Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)75, and EASI90 response.
“Roughly all patients maintain the treatment response they achieved at 16 weeks,” said Prof. Thaçi. This was noted in the as-observed analysis but also with the stricter non-responder imputation. By week 152, over 80% of participants who had initially achieved clear or almost clear skin (IGA 0/1) maintained this outcome. EASI75 showed similar outcomes. Interestingly, only a minor difference was seen between a treatment interval of every 2 or every 4 weeks (EASI75 response of 90.5% and 94.1%, respectively). EASI90 treatment responses were not only maintained but slowly increased up to 3 years: 79.4% of participants treated every 4 weeks and 86.8% of those treated every 2 weeks reached an EASI90 response at 152 weeks.
Througzout the study, intermittent use of topical corticosteroids was allowed. However, roughly 90% of participants did not need any rescue medication. “This is remarkable and shows the power of lebrikizumab to control the disease in a long-time manner,” Prof. Thaçi added.
The biologic was overall well tolerated and showed no new long-term safety signals. “The consistent efficacy of lebrikizumab over 3 years highlights its potential as a long-term treatment option for AD,” Prof. Thaçi concluded.
- Silverberg J, et al. N Engl J Med 2023;388:1080-91.
- Simpson EL et al. JAMA Dermatol 2023;159:182-91.
- Thaçi D. 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. D1T01.2E, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.
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Table of Contents: EADV 2024
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