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Clinical Trial
. 2022 Aug 6;22(1):535.
doi: 10.1186/s12888-022-04181-x.

Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) and intravenous immunoglobulin (IVIG): comprehensive open-label trial in ten children

Parisa Hajjari  1 , Malin Huldt Oldmark  1 , Elisabeth Fernell  1 , Klara Jakobsson  1 , Ingrid Vinsa  1 , Max Thorsson  1 , Mehran Monemi  2 , Lotta Stenlund  2 , Anders Fasth  3 , Catrin Furuhjelm  4 , Jakob Åsberg Johnels  1 , Christopher Gillberg  1 , Mats Johnson  5
Affiliations
Clinical Trial

Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) and intravenous immunoglobulin (IVIG): comprehensive open-label trial in ten children

Parisa Hajjari et al. BMC Psychiatry. .

Abstract

Background: Treatment with intravenous immunoglobulin (IVIG) in children with Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) has for many years been used on clinical indications, but the research evidence for its efficacy is insufficient.

Methods: Open-label prospective in-depth trial including ten children (median age 10.3 years) with PANS, who received IVIG treatment 2 g/kg monthly for three months. Primary outcomes were changes in symptom severity and impairment from baseline to first and second follow-up visits one month after first and one month after third treatment, using three investigator-rated scales: Paediatric Acute Neuropsychiatric Symptom (PANS) scale, Clinical Global Impression - Severity and Improvement (CGI-S and CGI-I) scales. Secondary outcomes reported here were changes in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores, and side effects.

Results: All ten children received three treatments at one-month intervals according to study plan. From baseline to second follow-up marked reductions were seen in mean total PANS scale scores (p = .005), and CGI-S scores (p = .004). CGI-I ratings showed much to very much global improvement (mean CGI-I 1.8). Nine children had clinical response defined as > 30% reduction in PANS Scale scores. Improvements were also noted for CY-BOCS scores (p = .005), and in school attendance. Three children suffered moderate to severe temporary side effects after the first treatment, and the remaining seven had mild to moderate side effects. Side effects were much less severe after second and third treatments.

Conclusions: Considerable and pervasive improvements in symptoms and clinical impairments were seen in these ten children after three monthly IVIG treatments. Moderate to severe transient side effects occurred in three cases.

Trial registration: EudraCT no. 2019-004758-27, Clinicaltrials.gov no. NCT04609761, 05/10/2020.

Keywords: Intravenous Immunoglobulin/IVIG; PANS; Paediatric Acute-onset Neuropsychiatric Syndrome.

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Conflict of interest statement

MJ received research grants from Shire/Takeda and has been engaged as a speaker or consultant by Shire/Takeda, SFI Health, PCM Scientific, Evolan, and New Nordic. AF received research grants from Shire and is presently advisor to Lipum AB. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CGI-Improvement scores at Visit 1 and Visit 3
Fig. 2
Fig. 2
CGI-Severity scores at Baseline, Visit 1 and Visit 3
Fig. 3
Fig. 3
Total PANS Scale scores at Baseline, Visit 1 and Visit 3 for individual patients
Fig. 4
Fig. 4
PANS Scale Symptom scores at Baseline, Visit 1 and Visit 3 for individual patients
Fig. 5
Fig. 5
PANS Scale Impairment scores at Baseline, Visit 1 and Visit 3 for individual patients
Fig. 6
Fig. 6
CY-BOCS scores at Baseline and Visit 3 for individual patients
See this image and copyright information in PMC

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References

    1. Swedo SE, Leckman JF, Rose NR. From research subgroup to clinical syndrome: modifying the PANDAS criteria to describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome) Pediatr Therapeut. 2012;2:113. doi: 10.4172/2161-0665.1000113. - DOI
    1. Frankovich J, Thienemann M, Pearlstein J, et al. Multidisciplinary clinic dedicated to treating youth with pediatric acute-onset neuropsychiatric syndrome: presenting characteristics of the first 47 consecutive patients. J Child Adolesc Psychopharmacol. 2015;25:38–47. doi: 10.1089/cap.2014.0081. - DOI - PMC - PubMed
    1. Chang K, Frankovich J, Cooperstock M, et al. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015;25:3–13. doi: 10.1089/cap.2014.0084. - DOI - PMC - PubMed
    1. Johnson M, Fernell E, Preda I, et al. Paediatric acute-onset neuropsychiatric syndrome in children and adolescents: an observational cohort study. Lancet Child Adolesc Health. 2019;3:175–180. doi: 10.1016/S2352-4642(18)30404-8. - DOI - PubMed
    1. Gromark C, Harris RA, Wickström R, et al. Establishing a pediatric acute-onset neuropsychiatric syndrome clinic: baseline clinical features of the pediatric acute-onset neuropsychiatric syndrome cohort at Karolinska Institutet. J Child Adolesc Psychopharmacol. 2019;29:625–633. doi: 10.1089/cap.2018.0127. - DOI - PMC - PubMed

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