Cognitive, Behavioral and Neuroinflammatory Parameters Improve in Autistic Children Treated with Intravenous Immune Globulin

Significant improvements in cognitive and behavioral function were observed in 14 children with autism spectrum disorder and evidence of immune dysfunction, who were administered high-dose intravenous immune globulin (IVIG) treatment over a period of 30 weeks, according to a pilot study conducted by U.S. investigators.

A select group of autistic children with a diagnosis of autistic disorder, Asperger’s disorder or pervasive developmental disorder and evidence of a dysregulated immune system received 1 g/kg of 5 percent IVIG (Gammaplex, Bio Products Laboratory) for 10 21-day treatment cycles. The primary endpoint was pre- and posttreatment disease improvement assessed using standardized cognitive and behavioral tests (e.g., Children’s Communication Checklist [CCC-2], Social Responsiveness Scale [SRS], Aberrant Behavior Checklist [ABC], Clinical Global Impressions-Severity [CGI-S] and Improvement [CGI-I], and Autism Diagnostic Observation Schedule [ADOS]). A number of experimental biomarkers associated with neuroinflammation were also captured.

Significant improvements from baseline to study endpoint were observed in several sub-scales of the CCC-2, SRS, CGI-I, CGI-S and ADOS, including associated maladaptive behavior (P ≤ 0.043), reciprocal social interaction (P ≤ 0.015), communication (P ≤ 0.001) and stereotyped behaviors and repetitive interests (P ≤ 0.013). Statistically significant reductions were also seen in numerous immunological biomarkers indicative of neuroinflammation. IVIG treatments were well-tolerated. These findings suggest inflammatory etiologies may play a role in some cases of autism, and IVIG treatment may, through an anti-inflammatory effect, exert a positive impact on its behavioral manifestations.