Case Report: Off-Label Use of Omalizumab in a 6-Year-Old Boy With ASD Ameliorated Severe Allergic Rhinitis and Subsequently Improved Behavioral Symptoms

Abstract

Children with ASD have elevated risk for developing allergic symptoms. The severity of allergic symptoms can exacerbate behavioral problems in children with ASD. Omalizumab, an anti-IgE antibody, has previously shown efficacy in treating allergic rhinitis and behavioral problems in a 12-year-old child with ASD. The present case report provides robust characterization of behavioral improvement in a 6-year-old child with ASD, allergic rhinitis, and autoimmune disorder. A 6-year-old boy with ASD and Hashimoto's disease presented to the clinic with severe allergic rhinitis, irritability, and language delay. After other treatments failed to improve symptoms, our patient was treated with omalizumab at 300 mg/month via subcutaneous injection for a total of 6 months. Marked improvement in allergic symptoms were observed at 2 months into treatment and were maintained through the treatment period. At the conclusion of the treatment period, results from multiple behavioral questionnaires, including the SRS-2, ABC, RBS-R, and PSQI, demonstrated substantial improvement in ASD-related behavioral symptoms. In this case, omalizumab markedly improved ASD-related and sleep behavior in a 6-year-old with ASD, allergic rhinitis, and autoimmune disorder. Future studies with larger patient populations are warranted to investigate the efficacy of omalizumab in patients with ASD and allergy symptoms.

An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics

“…Moreover, IgE-mediated mast cell activation and autoimmunity are potential pathogenic factors for ASD [ 21 ]. Thus, it has been hypothesized that the pathophysiology of IgE-mediated allergies may exacerbate ASD-related behavioral problems [ 22 ]. In this regard, omalizumab, a monoclonal anti-IgE antibody, could attenuate neuropsychiatric symptoms and cause subsequent improvement in cognitive development.…”

“…As shown in Supplementary Table S1 , in 2015, Jyonouchi [ 23 ] published a case report which showed that the use of omalizumab improved cognitive development and allergic symptoms. In 2021, Kong et al [ 22 ] confirmed it, showing that allergic symptoms can exacerbate behavioral symptoms, and omalizumab may be a promising symptomatic treatment for children with both ASD and IgE-mediated allergies.…”

“…The following are available online at , Table S1: Summary of the paediatric case reports on children treated with omalizumab [ 10 , 14 , 15 , 17 , 18 , 22 , 23 , 29 , 39 , 43 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 ], Table S2: Summary of the paediatric case reports on children treated with mepolizumab [ 53 , 54 , 58 , 59 ...…”