The EMA and FDA have recently approved lebrikizumab for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents. Previously, the safety and efficacy of lebrikizumab were reported up to 52 weeks. Now, Prof. Diamant Thaçi (University of Lübeck, Germany) presented the 3 years results of continuous treatment of lebrikizumab in responders from the phase 3 studies ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967)1.
Patients 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 as in the maintenance phase of ADvocate 1 and 2. Maintenance of response was evaluated for the Investigator Global Assessment (IGA), EASI75, and EASI90 response.
“Roughly all patients can maintain the treatment response they achieved at 16 weeks,” said Prof. Thaçi. This was noted in the as-observed analysis but also in 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 response showed a similar response. 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.
Throughout 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 this treatment to control the disease in a long-time manner,” Prof. Thaçi concluded.
The biologic was overall well tolerated and showed no new long-term safety signals.
Medical writing support provided by Dr Susanne Kammerer.