A new guideline from the European Academy of Allergy and Clinical Immunology (EAACI) recommends omalizumab as an add-on therapy for patients aged 12 to 17 years with chronic spontaneous urticaria (CSU) not sufficiently controlled by antihistamines.
The first-line treatment for CSU involves high-dose second-generation antihistamines. If that treatment proves insufficient, omalizumab becomes a second-line option.
According to Panida Sriaroon, MD, the medical director of the Food Allergy Clinic at Johns Hopkins All Children's Hospital, St. Petersburg, Florida, anti-inflammatory medications are sometimes employed in the treatment of CSU when higher doses of antihistamines fail to provide relief. "But these are like a Band-Aid," she said. "They make the patient feel better for a short period of time so they can go back to work or school, but they do not make the problem go away completely."
Ultimately, Sriaroon added, some patients shift to other agents. She did not participate in the creation of the guideline.
Omalizumab, the only biologic that has been approved by the US Food and Drug Administration for the treatment of CSU in patients aged 12 years or older, binds to the Fc region of free immunoglobulin E (IgE) and prevents IgE from further binding to FcεR1, a high-affinity receptor on basophils and mast cells.
Perhaps the most significant benefit associated with omalizumab is its convenience, explained Sriaroon in an interview with Medscape Medical News. "The biologic is an injection that can be done monthly in clinic or at home, so it's very convenient," she said.
In the new guideline, EAACI offers key evidence-based information on practical issues regarding the use of omalizumab in CSU, including the following: the definition of omalizumab response; when to evaluate response; how to manage anaphylaxis when receiving omalizumab; and how to manage infections and vaccinations when receiving omalizumab.
On the basis of current level of evidence, the guideline conditionally recommends omalizumab 150 mg every 4 weeks for adults and for adolescents aged 12 to 17 years with antihistamine-refractory CSU. This regimen, the guideline authors suggest, can reduce disease activity, improve quality of life, and minimize reliance on rescue medication.
The guideline makes a strong recommendation for omalizumab 300 mg every 4 weeks as a means of reducing disease activity, as measured by the Urticaria Activity Score and the itch-severity score. Although omalizumab has a good safety profile at both doses, the guideline recommends periodic monitoring for drug-related adverse events in adolescents.
Sriaroon noted that there are still several questions regarding the use of omalizumab for adolescents and adults with antihistamine-refractory CSU.
One of those questions pertains to how long omalizumab therapy should be continued. "For instance, if the patient tries omalizumab and it has been 6 months and they have not responded, it's unknown whether we should we stop or actually continue for another 6 months," she said. "On the other hand, if the patient has responded beautifully to omalizumab, meaning the quality of life improved significantly and they don't need to take any add-on medications or rescue medications, when do we stop the treatment?"
Anna Wolfson, MD, an allergist-immunologist at Massachusetts General Hospital, Boston, Massachusetts, said in an email to Medscape Medical News that the new guideline will likely prove useful for clinicians and pediatricians as an evidence-based resource specific for the pediatric population.
"Still, many questions remain regarding the use of this agent in children and adults," said Wolfson, who wasn't involved in creating the guideline. "For example, I would love to be able to predict which patients will respond to omalizumab. Alternative dosing regimens are also often requested from patients, but the data are sparse."
Wolfson added that there is also a gap in the research and clinical knowledge regarding when patients can be tapered off omalizumab. Further clinical guidance may be necessary in this area.
Aikaterini Anagnostou, MD, who serves as the director of the Food Immunotherapy Program at Texas Children's Hospital, Houston, Texas, added that there are few long-term efficacy and safety data on the use of omalizumab in the pediatric CSU population. "Duration of treatment in responders and the role of different long-term regimens also warrant further investigation," explained Anagnostou, who wasn't involved in creation of the guideline. "The impact of race and ethnicity on efficacy and safety of omalizumab are also currently unknown."
The guideline authors, Sriaroon, Wolfson, and Anagnostou have disclosed no relevant financial relationships.
Allergy. Published online July 29, 2021. Abstract
Brandon May is a freelance medical journalist who has written more than 1800 articles for medical publications in the United States and the United Kingdom. He resides in New York City. Twitter: @brandonmilesmay.
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Cite this: New Guideline on Omalizumab for Adolescents With Chronic Spontaneous Urticaria - Medscape - Aug 06, 2021.