Abstract
Background
Atopic eczema/dermatitis syndrome (AEDS) is a chronic inflammatory skin disease, affecting 10–20% of children and 1–3% of adults. The purpose of this pilot study was to assess the clinical and anti-inflammatory effect of bacterial and ribosomal immunotherapy with Immucytal® (Pierre Fabre Médicament, France) in children with AEDS.
Methods
Seventeen children with allergic and non-allergic forms of AEDS (AAEDS and NAAEDS, respectively), graded moderate to severe (Severity Scoring of Atopic Dermatitis [SCORAD] index of >25), received ribosomal immunotherapy (Immucytal®) once daily according to the standard treatment regimen (4 consecutive days a week for 3 weeks, and then 4 consecutive days a month for 4 months). We assessed the clinical status of AEDS using the SCORAD index at baseline, and after 8 and 20 weeks of treatment. Furthermore, peripheral blood from patients was examined for the frequencies of CD4+ cells expressing interferon (IFN)-ψ and interleukin (IL)-4 using flow cytometry.
Results
There was a progressive and significant clinical improvement of AEDS, confirmed by a reduction of the SCORAD index over time in both AEDS forms (p < 0.01). Pooled data from the two groups showed that the mean baseline index of 43 was reduced to 17 after treatment. Overall, these data indicate a marked improvement in total clinical severity of AEDS (−62%). Flow cytometry analysis showed that frequencies of the two CD4+ T cell subsets did not differ significantly from the beginning to the end of the study in both forms of AEDS. However, the percentage of CD4+ cells expressing IL-4 in children with AAEDS tended to decrease by the end of treatment with ribosomal immunotherapy. Clinical and laboratory data confirmed that immunotherapy was well tolerated.
Conclusions
The results of this pilot investigation suggest that ribosomal immunotherapy may be beneficial in the management of AEDS in children, and that this could be at least partially explained by a role in restoring the type 2 helper-T cell imbalance seen in allergic patients. Placebo-controlled, randomized clinical trials are recommended in order to confirm these findings.
Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
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Acknowledgments
Luigia Brunetti and Ruggiero Francavilla contributed equally to the work. The authors have no conflicts of interest relevant to the contents of this manuscript and have received no funding or assistance with regard to this study. No collaborators other than the authors were involved in the preparation of this manuscript. This paper is an accurate representation of the study results.
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Brunetti, L., Francavilla, R., Tesse, R. et al. Effects of Oral Bacterial Immunotherapy in Children with Atopic Eczema/Dermatitis Syndrome. BioDrugs 19, 393–399 (2005). https://doi.org/10.2165/00063030-200519060-00006
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DOI: https://doi.org/10.2165/00063030-200519060-00006