Dermatologic and Ocular Diseases
Intradermal administration of a killed Mycobacterium vaccae suspension (SRL 172) is associated with improvement in atopic dermatitis in children with moderate-to-severe disease

https://doi.org/10.1067/mai.2001.113081Get rights and content

Abstract

Background: Although a doubling in the prevalence of atopic disease, including atopic dermatitis, in the Western world over the last few generations has been paralleled by a marked reduction in infectious diseases, especially tuberculosis, it is unclear whether this increase in atopy is causally related to reduced exposure to mycobacteria. Objectives: The aim of this study was to determine whether administration of mycobacterial antigens to atopic individuals might ameliorate their disease. Methods: Forty-one children aged 5 to 18 years with moderate-to-severe atopic dermatitis were enrolled in a randomized, double-blind, placebo-controlled trial, where they were given either one intradermal injection of killed Mycobacterium vaccae (SRL 172) or buffer solution (placebo). Changes in skin surface area affected by dermatitis and dermatitis severity score were assessed before treatment and at 1 and 3 months after treatment. Results: Children treated with SRL 172 showed a mean 48% (95% CI, 32%-65%) reduction in surface area affected by dermatitis compared with a mean 4% (95% CI, –29% to 22%) reduction for the placebo group (P < .001) and a median 68% (interquartile range, 46%-85%) reduction in dermatitis severity score compared with 18% (interquartile range, –2% to 34%) for the placebo group (P < .01) at 3 months after treatment. There were no untoward effects of the treatment, apart from a local reaction in 13 of the 21 children, which occurred 1 month after SRL 172 administration and settled spontaneously. Conclusion: SRL 172 was associated with an improvement in the severity of the dermatitis in children with moderate-to-severe disease. (J Allergy Clin Immunol 2001;107:531-4.)

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Patients and study design

This study was conducted as a single-center, randomized, double-blind, placebo-controlled trial. The children enrolled in the study, aged 5 to 18 years, attended the University Department of Child Health outpatient clinic at Booth Hall Children’s Hospital, a regional referral center for unusually severe or persistent atopic dermatitis. Sixty children with moderate-to-severe atopic dermatitis were initially considered for the study. Eight children and their parents declined to take part, 7 were

Baseline characteristics

The baseline characteristics of the children with atopic dermatitis who took part in the study are shown in Table I.

. Baseline characteristics of subjects with atopic dermatitis randomized to placebo or SRL 172

CharacteristicPlaceboSRL 172P value
No.2021
Age (y)10 ± 49 ± 4.3
Male patients, n (%)12 (60)6 (29).04
White patients, n (%)13 (65)16 (76).4
Surface area affected (%)40 ± 3038 ± 30.8
Dermatitis score (0-300)38 (22-86)55 (19-69).8
IgE 1000 kU/mL (≤0.1)6.6 (1.7-19.7)9.2 (0.6-15.2).8
Blood eosinophil

Discussion

This randomized, double-blind, placebo-controlled study demonstrated that in the cohort of children studied, there was a significant reduction in the severity of their atopic dermatitis after a single intradermal injection of killed M vaccae suspension (SRL 172) without any major adverse effects. The lack of any placebo effect may relate to the relatively short duration of the trial and the objectivity of the assessment scores, especially the use of surface area affected by dermatitis as the

Acknowledgements

We thank Dr Leena Patel and Dr Carol Ewing for permission to use their patients in this study; Dr Kath. Bennett, CRC Paediatric and Familial Cancer Group, University of Manchester, for statistical advice; SR Pharma Ltd, London for providing SRL 172 and matching placebo; and Mrs Franscine Radavan and the pharmacy staff at Booth Hall Children’s Hospital for randomizing and allocating the treatments to the patients. Measurements of IgE levels were performed by the staff of the Department of

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Reprint requests: Peter D. Arkwright, MB, DPhil, Academic Unit of Child Health, University of Manchester, Booth Hall Children’s Hospital, Charlestown Rd, Manchester, M9 7AA, United Kingdom.

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