Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study.
BACKGROUND
Environmental factors play a major role on atopic dermatitis (AD) which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend.


OBJECTIVE
This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®), in the treatment of established AD in children.


METHODS
Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF) during the study period, evaluated by Hazard Ratio (HR) derived from conditional Cox proportional hazard regression models accounting for repeated events.


RESULTS
Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85%) patients in the OM-85 group and 72 (88%) in the placebo group). Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI): 0.67-0.96), also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98). No major side effect was reported, with comparable and good tolerability for OM-85 and placebo.


CONCLUSIONS
Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.
Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Department of Dermatology, Paris, France.
Christine
C
Bodemer
Université de Poitiers, Department of Dermatology, Poitiers, France.
Gerard
G
Guillet
Université de St-Etienne, Hôpital de St-Etienne, Department of Dermatology, Saint-Etienne, France.
Frederic
F
Cambazard
Université de Bordeaux, Hôpital Pellegrin-enfants, Pediatric Dermatology Unit, Bordeaux, France.
Franck
F
Boralevi
Vifor Pharma/OM Pharma, Meyrin, Switzerland.
Stefania
S
Ballarini
Vifor Pharma/OM Pharma, Meyrin, Switzerland.
Christian
C
Milliet
Università degli Studi di Milano, Department of Clinical Sciences and Community Health, Milan, Italy.
Paola
P
Bertuccio
Università degli Studi di Milano, Department of Clinical Sciences and Community Health, Milan, Italy.
Carlo
C
La Vecchia
Université Paris Descartes, Sorbone Paris Cité, Paris, France.|INSERM U1151- CNRS UMR 8253, INEM (Institut Necker Enfants Malades), Paris, France.
Jean-François
JF
Bach
Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Department of Dermatology, Paris, France.
Yves
Y
de Prost
D000277:Adjuvants, Pharmaceutic / Q000627:therapeutic use*; D000284:Administration, Oral; D000305:Adrenal Cortex Hormones; D002457:Cell Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000453:epidemiology; D003879:Dermatologic Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D015995:Prevalence; D016896:Treatment Outcome; D000095983:Bacterial Lysates
D000277:Adjuvants, Pharmaceutic; D000305:Adrenal Cortex Hormones; D002457:Cell Extracts; D003879:Dermatologic Agents; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates