Two new atopic dermatitis biologics show promising results in phase IIb clinical trials


By National Eczema Association

Published On: Jul 15, 2019

Last Updated On: Jul 13, 2021

Ever since the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab), other biologics have been making their way through clinical trials.

Biologics are injectable drugs that use an antibody to treat a disease at the immune system level. And the more scientists understand how the different levels of the immune system can be targeted for therapy, the better their chances of developing safe and effective treatments.

The human body uses certain types of signaling molecules called interleukins, or ILs, which help our immune system fight off harmful viruses and bacteria. But for people with AD, their immune system tends to overreact and trigger certain ILs to produce inflammation.

Biologics block ILs from binding to their cell receptors, which keeps the immune system from overreacting, thereby lowering inflammation and decreasing symptoms of AD. Dupilumab, made by Regeneron Pharmaceuticals and Sanofi Genzyme, was the first, and for the time being, remains the only FDA-approved biologic for AD. It targets the IL 4 and IL 13 receptors.

Two new atopic dermatitis biologics on the way

Several more biologics have been making their way through the development pipeline, including Galderma’s nemolizumab and Dermira’s lebrikizumab. Both treatments recently completed their phase IIb clinical trials.

Results for nemolizumab’s phase IIb trial were presented at the Annual Meeting of the American Association of Dermatology, which took place March 2019 in Washington, D.C. Nemolizumab is an antibody that blocks the IL 31 receptor.

The results of the trial were positive, with participants on the 30 milligram (mg) dose of nemolizumab achieving a 68.8% skin improvement from baseline Eczema Area and Severity Index (EASI) at week 24, compared to those on placebo achieving a 52.1% improvement in EASI.

This phase IIb study had adults who were uncontrolled by topical corticosteroids (TCS) and topical calcineurin inhibitors randomized into the placebo group, the 10 mg dose group, the 30 mg dose group or the 90 mg dose group.

To qualify for the study, participants had to have an EASI of 12 or greater and a body surface area (BSA) involvement of at least 10%. Participants had a run-in period of four weeks with mid-potency TCS used for stabilization.

The safety profile for nemolizumab was positive, with patients from all dose groups having either a similar or lower rate of adverse events. The most common adverse events were nasopharyngitis (found in 26.6% of nemolizumab participants vs. 21.4% in the placebo group), exacerbation of AD (24.9% in the nemolizumab groups vs. 32.1% in the placebo group), and non-herpes skin infection (13% in the nemolizumab groups vs. 12.5%  in the placebo group).

Meanwhile, Dermira announced positive results from its phase IIb dose-ranging study of lebrikizumab, a biologic that targets IL13, in adults with moderate to severe AD. All three doses of lebrikizumab demonstrated greater improvements in the EASI score compared to the placebo.

The improvement in EASI score was 62.3% for patients receiving 125 mg every four weeks, 69.2% for patients receiving 250 mg every four weeks, and 72.1% for patients receiving 250 mg every two weeks compared to 41.1% for the placebo group.

The most common adverse events reported across all three lebrikizumab dosing groups were upper respiratory tract infection (7.5% vs. 5.8% for the placebo), nasopharyngitis (6.6% vs. 3.8% for placebo), headache (3.1% vs. 5.8% for placebo), injection site pain (3.1% vs. 1.9% for placebo), conjunctivitis (2.6% compared to no reports for the placebo), and herpes infections (2.2% compared to no reports for the placebo).

Overall, adverse events observed in both biologics were mild to moderate in severity and seldom led to treatment discontinuation. To research more eczema treatments in the development pipeline, visit Eczema Treatments in Development.

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