Omalizumab is effective in treating severe atopic dermatitis in children. Researchers found that not only did omalizumab improve the symptoms associated with atopic dermatitis, patients receiving the drug reported an improved quality of life and were also able to reduce their use of topical corticosteroids.
Be aware that omalizumab is an expensive drug and the benefits and risks of its use should be weighed.
Omalizumab, a recombinant, humanized, monoclonal antibody against human immunoglobulin E (IgE), is effective in treating children with severe atopic dermatitis, researchers found.
Results from the ADAPT randomized trial showed that the drug reduced atopic dermatitis severity and improved quality of life in pediatric patients, despite these children having highly elevated total IgE levels at baseline.
In their article, Susan Chan, MD, Guy’s and St Thomas’ NHS Foundation Trust, London, and colleagues noted that atopic dermatitis is one of the most common forms of eczema, affecting 7.7% of children ages 6 to 7 years and 7.3% of adolescents ages 13 to 14 years worldwide.
System immunosuppressants have been used to treat severe cases of atopic dermatitis, but according to Chan and colleagues, the evidence of the effectiveness of these drugs is limited.
Omalizumab is designed to bind human IgE, limiting mast cell degranulation and inflammatory mediator release, and is well tolerated in children with severe asthma. Here, Chan and colleagues hypothesized that anti-IgE medication would reduce IgE levels in children with severe eczema and alleviate their symptoms.
THE ADAPT trial was a single-center, double-blind, parallel-group, placebo-controlled trial involving 62 children, ages 4 to 19 years, with severe eczema (objective Scoring Atopic Dermatitis [SCORAD] index >40) that has not responded to optimal therapy.
Children in the intervention group received subcutaneous omalizumab for 24 weeks, with dosing based on total IgE and body weight at the time the children were randomized. The main outcome of the trial was the object SCORAD index at 24 weeks.
Of the 32 children randomized to placebo, four withdrew from the trial, while one of the 30 children randomized to receive omalizumab withdrew. All of the other trial participants achieved 100% treatment adherence.
At 24 weeks, the difference between the change in objective SCORAD index in each group was −6.9 (95% CI, −12.2 to −1.5; P = .01) in favor of omalizumab.
Improvements were also observed in favor of treatment with omalizumab for other atopic dermatitis severity scores. For example, the adjusted mean treatment different for the Eczema Area and Severity index (which, ranging from 0 to 72, grades the severity of the physical signs of atopic dermatitis and the extent of its severity) was −6.7 (95% CI, −13.2 to −0.1) in favor of omalizumab, while the adjusted mean treatment group difference for the Patient-Oriented Eczema Measure was also in favor of omalizumab.
In addition, improved quality-of-life scores were seen in the omalizumab group, as measured by the Children’s Dermatology Life Quality Index/Dermatology Life Quality Index and Pediatric Allergic Disease Quality of Life Questionnaire score.
These improvements "occurred in the context of markedly potent topical corticosteroid sparing in the omalizumab group," noted Chan and colleagues. Specifically, the patients in the omalizumab group reduced the percentage of body surface area covered with topical corticosteroids (16% compared to 31% in the placebo group) and reduced the median number of days of use (109 versus 161 in the placebo group).
Seven serious adverse events occurred in six patients in each group (20% in omalizumab and 19% in placebo), one of which was serious potential adverse reaction in a patient in the omalizumab group who reported experiencing anaphylaxis after a treatment injection. That participant had a preexisting history of idiopathic anaphylaxis and weekly allergic reactions.
"Future work with an even larger sample size, a longer duration, and higher affinity versions of omalizumab would clarify the precise role of anti-IgE therapy and its ideal target population," concluded Chan and colleagues. "Such a study would enable clarification of the optimal treatment duration, age at treatment, and baseline total IgE levels."
In an editorial accompanying the study, Amy Chen Wu, MD, MPH, Center for Healthcare Research in Pediatrics, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, wrote that while the study suggests omalizumab is effective in treating atopic dermatitis in children, questions remain regarding whether it is cost effective.
A number of questions need to be answered, she argued. For example, do the high costs associated with atopic dermatitis justify the costs of treatment with an expensive drug like omalizumab? And, what are the harms and benefits of omalizumab, and who is most likely to benefit from the drug?
"Specifically, which patients with atopic dermatitis should receive omalizumab given the high costs of this medication?" Wu asked. "Is using a $100,000-per-year medication for an itchy condition an overtreatment or a lifesaver?"
Chan reported receiving grants from the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme, grants from Guy’s and St. Thomas’ Charity, and active and placebo drugs from Novartis during the conduct of the study.
Wu reported receiving a grant from GlaxoSmithKline.