Lebrikizumab-Treated Patients With Atopic Dermatitis Had No Increase in Treatment-Emergent Adverse Events of Facial, Head, and Neck Erythema Compared to Placebo

■ Use of some advanced systemic therapies has been associated with the development of facial, head, and neck erythema in patients with AD ■ Potential causes include Th2/Th1 cytokine profile switching, undiagnosed allergic contact dermatitis, reaction to facial Malassezia species, 1 colonization of Demodex mite, 2 resistance of facial AD to therapy, or drug eruption ■ Lebrikizumab is a monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of IL-13 with high potency 3 ■ Lebrikizumab has demonstrated a positive benefit-risk profile and efficacy in Phase 2 and Phase 3 clinical trials for AD 4-7 OBJECTIVE ■ To assess the development of facial, head, and/or neck erythema in patients taking lebrikizumab for moderate-to-severe AD SUMMARY OF KEY FINDINGS ■ Treatment-emergent adverse events of facial, head, and/or neck erythema were not increased in patients with moderate-to-severe AD treated with lebrikizumab compared with placebo ■ The IR did not increase with increased number of exposure years to lebrikizumab CONCLUSIONS ■ The development of treatmentemergent adverse events of facial, head, and/or neck erythema is not more common in patients with moderate-tosevere AD taking lebrikizumab than those taking placebo ■ IR does not increase with increased number of exposure years to lebrikizumab METHODS Integrated Safety Analysis Study Design 8 PBO-Controlled, Weeks 0-16 Analysis Set ■ Patients treated with LEBRI 250 mg Q2W compared with placebo, for 16 weeks ■ 4 studies: ADvocate1, ADvocate2, ADhere, and a Phase 2b study All LEBRI Analysis Set ■ Patients who received ≥1 dose of LEBRI ■ 8 studies: ADvocate1, ADvocate2, ADhere, ADjoin, ADore, TREBLE, ARBAN, and a Phase 2b study Assessments and Statistical Analyses■ Treatment-emergent AEs were analyzed for specified terms related to facial, head, and neck erythema in adults and adolescents with moderate-to-severe AD based on patients who received ≥1 dose of study treatment, excluding 38 patients from one study site as the patient eligibility criteria could not be confirmed ■ Blinded medical review was completed ■ For PBO-controlled group, adj % and adj IRs were used to report AEs ■ For All LEBRI group, crude % and IRs were reported ■ Adj IRs were calculated as the number of patients reporting an event per 100 PYR RESULTS Development of Treatment-Emergent Facial, Head, and/or Neck Erythema a Limitations■ These findings need to be confirmed in the real-world setting Baseline Patient Demographics and Disease Characteristics

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