FDA Approves Lebrikizumab-lbkz for Moderate to Severe AD: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on the US Food and Drug Administration (FDA) approval of lebrikizumab-lbkz for adults and children aged 12 years and older with moderate-to-severe atopic dermatitis (AD) not controlled by topical therapies.

The approval

Lebrikizumab-lbkz is an IL-13 inhibitor is indicated for treatment of adults and of pediatric patients who weigh at least 88 pounds (40 kg) and can be used with or without topical corticosteroids.

The approval is supported by positive data from the ADvocate 1 and ADvocate 2 phase 3 clinical trials that evaluated lebrikizumab as monotherapy in adults and children aged 12 years and older and the ADhere phase 3 study that assessed the efficacy and safety of the biologic in the same populations but used in combination with topical steroids. More than 1000 adults and children aged 12 years and were enrolled across the 3 studies. Participants had moderate-to-severe AD uncontrolled by topical prescription medications and the primary endpoint for the trial trio was assessed at 16 weeks and measured clear or almost clear skin.

When data from ADvocate 1 and ADvocate 2 were averaged, 38% of the participants who received the lebrikizumab 250 mg/2 mL injection achieved clear or almost clear skin at 16 weeks, compared to 12% who received placebo treatment. Further, 10% saw the results as early as 4 weeks. Of those whose skin was evaluated as clear or almost clear after 16 weeks, results were maintained for 77% at one year with monthly maintenance doses. Notably, almost half (48%) of those with good response who were switched to placebo after 16 weeks also maintained results at 52 weeks.

Findings for itch relief also favored lebrikizumab with 43% of lebrikizumab-treated participants experiencing relief at 16 weeks, versus 12% with placebo, with 5% feeling relief as early as 2 weeks. Among those with itch relief at week 16, 85% continued to feel relief after a year on monthly maintenance treatment, and 66% maintained relief at the 52-week mark after switching to placebo.

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