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.

Keywords: allergic rhinitis; anxiety; autism spectrum disorder; omalizumab; sleep disturbance.

Figure 1

Case Timeline. Color bar is a qualitative, visual representation of patient overall symptom severity over the course of the case, wherein red indicates severe symptomology and green mild/no symptomology. Red diamond timepoints indicate months during which omalizumab treatment was administered.

Figure 2

Social Responsiveness Scale-2 (SRS) sub-scores prior to the initiation of omalizumab (blue) and after the 6 month treatment period (red).

Figure 3

Aberrant Behavior Checklist (ABC) sub-scores prior to the initiation of omalizumab (blue) and after the 6 month treatment period (red).

Figure 4

Repetitive Behavior Scale-Revised (RBS-R) sub-scores prior to the initiation of omalizumab (blue) and after the 6 month treatment period (red).

Figure 5

Pittsburgh Sleep Quality Index (PSQI) sub-scores prior to the initiation of omalizumab (blue) and after the 6 month treatment period (red).

Figure 6

Total scores before initiation of omalizumab (blue) and after the treatment period (red) for the Epworth Sleepiness Scale (ESS), General Anxiety Disorder 7-item (GAD-7) scale, Clinical Global Impressions – Severity (CGI-S) scale, and the Rhinitis Control Assessment Test (RCAT). In contrast to other parameters, RCAT scores indicate better improvement with higher scores, while the rest of the tests indicate better improvement with lower scores. The Clinical Global Impressions - Improvement (CGI-I) was rated a 2 at the conclusion of the treatment period, indicating “much improved” symptoms.