February 27, 2015
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Xolair effective, well tolerated in children aged younger than 12 years
HOUSTON — Xolair was well tolerated and significantly improved asthma control among children aged younger than 12 years, according to data presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
“Omalizumab is FDA approved for treatment of moderate to severe persistent allergic asthma in patients aged 12 years and older who are not controlled by inhaled corticosteroids,” study researcher Sayantani B. Sindher, MD, of The Children’s Hospital of Philadelphia, and colleagues wrote. “There is limited data on its use in patients younger than 12 years.”
Researchers reviewed medical records of 32 children (mean age, 11.3 years; 50% boys) who received Xolair (omalizumab, Genentech) from January 2008 to June 2014 to identify asthma control test scores and the number of asthma exacerbations 52 weeks after treatment initiation. The cohort ranged in age from 6 years to 17 years, with 65% aged younger than 12 years.
After therapy, asthma control test scores improved by 8 points over baseline (P < .0001).
Overall hospitalizations decreased by 76%, and ED visits fell by 71%. Among participants aged younger than 12 years, ED visits decreased by 72%, hospitalizations declined by 80% and oral steroid courses decreased by 66% (P < .0001). Overall steroid use declined by 58%.
The rate of adverse events was 0.68% among administered injections.
“Omalizumab dramatically improved asthma control and is well tolerated in a pediatric population where the majority of children were aged younger than 12 years,” Sindher and colleagues concluded. – by Amanda Oldt
Reference:
Sindher SB, et al. Abstract 5. Presented at: the American Academy of Allergy, Asthma & Immunology Annual Meeting; Feb. 20-24, 2015; Houston.
Disclosure: Infectious Diseases in Children was unable to confirm financial disclosures at the time of publication.
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Gary Rachelefsky, MD
This retrospective chart review over a 6 to 7 year period demonstrates the effectiveness of adding omalizumab (Xolair) to the management of severe asthma in children.
Based on my experience in adults, if one selects the right patient (moderate to severe asthma with a significant allergic component), omalizumab could be very effective.
In this abstract, the authors present data using an acceptable instrument (the Asthma Control Test) to demonstrate its effectiveness in a childhood population. At this point we do not know how long to continue the treatment with omalizumab and how it affects long-term outcome.
Gary Rachelefsky, MD
Infectious Diseases in Children Editorial Board member
University of California, Los Angeles
Disclosures: Infectious Diseases in Children was unable to confirm relevant financial disclosures at the time of publication.
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Sandy Durrani, MD
Currently, we have limited therapies to treat children aged younger than 12 years with severe asthma.
To date, only a few studies of omalizumab have been conducted in young children. These studies can be challenging to conduct, so a real life study may give us additional information.
Although a small number of children were studied, the significant improvement in symptom burden and healthcare utilization support the use of omalizumab in this population.
Sandy Durrani, MD
Assistant Professor, Department of Pediatrics
Cincinnati Children's Hospital & Medical Center
Disclosures: Durrani reports no relevant financial disclosures.
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Theresa W. Guilbert, MD, MS
There is limited data on the use of omalizumab in children aged younger than 12 years.
This study was a retrospective chart review of 32 children aged 6 to 17 years who received omalizumab at an academic children¹s hospital to assess the effectiveness and safety of omalizumab.
Significant improvement in Asthma Control Test (ACT) scores and decrease in the number of hospitalizations and oral corticosteroid courses were observed. Although this review included a small number of patients, this study supports the clinical use of omalizumab in young children with severe asthma.
Theresa W. Guilbert, MD, MS
Professor of Pediatrics, Associate Director of the Asthma Center, Division of Pulmonology Medicine
Cincinnati Children's Hospital & Medical Center
Disclosures: Guilbert reports financial ties with Roche and Genentech.