Omalizumab Reduces Atopic Dermatitis Severity, Improves QOL in Kids

By Anne Harding

November 28, 2019

NEW YORK (Reuters Health) - Omalizumab reduces the severity of atopic dermatitis (AD) in children, though it's not clear the improvement is clinically significant, according to a new randomized controlled trial.

"To our knowledge, this is the largest trial using anti-IgE therapy in atopic dermatitis and the first to demonstrate a positive clinical outcome. This may be because it primarily targets a younger population, with more acute disease," said Dr. Susan Chan of Guy's and St Thomas' NHF Foundation Trust in London.

"Compared to previous studies, newer licensing allowed a higher dose of anti-IgE to be used in this study to more effectively neutralise circulating IgE, which may account for the improved efficacy," she told Reuters Health by email.

Omalizumab, made by Genentech and sold as Xolair, was approved in 2003 by the U.S. Food and Drug Administration for treating allergic asthma in adults and children, and in 2014 for treating chronic idiopathic urticaria. The drug binds human IgE, "limiting mast cell degranulation and inflammatory mediator release," Dr. Chan and her team note in Pediatrics, online November 25.

In the Atopic Dermatitis Anti-IgE Pediatric Trial (ADAPT), the authors randomly assigned 62 patients with severe refractory eczema to receive subcutaneous omalizumab or placebo weekly for 24 weeks.

Dosage ranged from 30 to 1,500 IU/mL, based on IgE levels and body weight at randomization. Mean Scoring Atopic Dermatitis (SCORAD) index was 54.9 at baseline, and median total IgE level was 8,373 IU/mL.

The SCORAD index improved by 6.9 points more in the omalizumab group than in the placebo group (P=0.01), with the minimum clinically important difference of 8.5 contained within the 95% confidence interval of 1.5 to 12.2. Study participants also had greater improvements in quality of life scores.

Patients on omalizumab used fewer topical steroids than those on placebo, with a median 16% of body surface area covered versus 31% for the placebo group. Days of use were 109 days and 161 days, respectively.

"Further work with a larger sample size, a longer duration of treatment and next generation, higher-affinity versions of anti-IgE would clarify the precise role of anti-IgE and the ideal target population," Dr. Chan said.

"Omalizumab may be a potential treatment for children with severe atopic dermatitis or eczema, however, many caveats exist," Dr. Ann Wu of Harvard Medical School in Boston, who wrote an editorial accompanying the study, told Reuters Health by email. "Before omalizumab can be used for widespread clinical use, cost-effectiveness needs to be addressed as omalizumab is very expensive. Justification of the use of omalizumab to payers, including health insurers and patients, and policy makers will be needed."

She noted that the per-patient, per-year cost for omalizumab at the doses used in the study would total more than $100,000, not including costs for administering the drug. Only about half of studies looking at omalizumab for asthma have found it to be cost-effective, she added.

"Asthma is a more-severe disease than atopic dermatitis on average; thus, I don't know if omalizumab at current pricing would be cost-effective for atopic dermatitis," she said.

"Additional studies to assess effectiveness in a real-life population of children would be needed as questions remain on whether children would be adherent to a treatment regimen that includes injections every 2 to 4 weeks," Dr. Wu added. "It's hard enough to convince some children to receive routine immunizations that are less frequent."

Novartis provided omalizumab and placebo for the study, but did otherwise support it. One of Dr. Chan's coauthors reports financial ties to the company unrelated to the study.

SOURCE: https://bit.ly/2scgdtF and https://bit.ly/2Om4Vvt

JAMA Pediatr 2019.

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