Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features

Öz

OM-85 is an immunomodulatory agent used for the prevention of recurrent respiratory tract infections (RTIs) in children; however, the influence of allergic and immunological characteristics on treatment response remains unclear. This study evaluated changes in infection frequency before and after OM-85 treatment and examined whether treatment response was associated with allergic status or immunological characteristics. This single-center, retrospective cohort study included 114 children treated with OM-85 for recurrent RTIs. Annual upper (URTI) and lower (LRTI) respiratory tract infection episodes before and after treatment were compared. Treatment responses were analyzed according to atopic status, inhalant allergen sensitization, and immunoglobulin status (normal, transient hypogammaglobulinemia, and partial IgA deficiency). Independent predictors of post-treatment infection burden were assessed using multivariable linear (ANCOVA) and negative binomial regression analyses. The median age was 56.5 months; 46.5% of patients were atopic, 28.1% had partial IgA deficiency, and 8.8% had transient hypogammaglobulinemia. Following OM-85 treatment, median annual URTI episodes decreased from 8 to 5 (40.6%; p<0.001; r=0.78), and LRTI episodes from 1 to 0 (63.2%; p<0.001; r=0.54). The proportion of children with frequent URTIs (≥6/year) declined from 84.2% to 33.3%, and those with at least one LRTI episode from 60.5% to 32.5%. The reduction was significant in both atopic and non-atopic patients and in subgroups with normal or low immunoglobulin levels. In multivariable analysis, the only independent predictor of post-treatment burden was baseline infection burden. OM-85 treatment was associated with a reduction in both upper and lower respiratory tract infection frequency independently of allergic status and serum immunoglobulin level, with baseline infection burden being the factor most strongly associated with post-treatment infection burden. The greatest clinical benefit is expected in children with frequent infections, and this group may constitute a priority target population for this preventive strategy.

Anahtar Kelimeler

• OM-85
• Recurrent Respiratory Tract Infection
• Atopy
• Immunoglobulin

Destekleyen Kurum

The authors declared that they received no financial support for this study.

Etik Beyan

Ethics Committee Approval Information: Approving Committee: University of Health Sciences, Bursa Faculty of Medicine, and the Bursa City Hospital Approval Date: 05.02.2025 Decision No: 2025-3/1

Tekrarlayan Solunum Yolu Enfeksiyonu Olan Çocuklarda OM-85 Etkinliğinin Alerjik ve İmmünolojik Özelliklerle İlişkisi

Öz

OM-85, çocuklarda tekrarlayan solunum yolu enfeksiyonlarının önlenmesinde kullanılan bir immünomodülatördür; ancak alerjik ve immünolojik özelliklerin tedavi yanıtı üzerindeki etkisi halen tam olarak açıklığa kavuşmamıştır. Bu çalışmada OM-85 tedavisi başlanan çocuklarda tedavi öncesi ve sonrası enfeksiyon sıklığını ve bunun alerjik durum ile immünolojik özelliklerle ilişkisini değerlendirmeyi amaçladık. Bu tek merkezli, retrospektif kohort çalışmasına tekrarlayan solunum yolu enfeksiyonu (SYE) nedeniyle OM-85 başlanan 114 çocuk alındı. Tedavi öncesi ve sonrası yıllık üst (ÜSYE) ve alt (ASYE) solunum yolu enfeksiyon atakları karşılaştırıldı. Atopik/non-atopik, inhalan duyarlı/duyarsız ve immünglobulin düzeyi durumu (normal, transient hipogamaglobulinemi, parsiyel IgA eksikliği) incelendi. Tedavi sonrası enfeksiyon yükünün bağımsız belirleyicileri çok değişkenli doğrusal (ANCOVA) ve negatif binomiyal regresyonla değerlendirildi. Ortanca yaş 56,5 aydı; olguların %46,5'i atopik, %28,1'i parsiyel IgA eksikliği ve %8,8'i transient hipogamaglobulinemi grubundaydı. OM-85 sonrası yıllık ÜSYE atağı ortanca 8'den 5'e (%40,6; p<0,001; r=0,78), ASYE 1'den 0'a (%63,2; p<0,001; r=0,54) geriledi. Sık ÜSYE (≥6/yıl) oranı %84,2'den %33,3'e, herhangi bir ASYE atağı oranı %60,5'ten %32,5'e düştü. Azalma; hem atopik hem non-atopik hastalarda ve normal ya da düşük immünglobulin düzeyine sahip alt gruplarda anlamlıydı. Çok değişkenli analizde tedavi sonrası enfeksiyon yükünün tek bağımsız belirleyicisi bazal enfeksiyon yüküydü. OM-85 tedavisi, alerjik durum ve serum immünglobulin düzeyinden bağımsız olarak hem üst hem alt solunum yolu enfeksiyon sıklığında azalma ile ilişkiliydi; tedavi sonrası enfeksiyon yüküyle en güçlü ilişkili faktör bazal enfeksiyon yüküydü. En fazla klinik yarar sık enfeksiyon geçiren çocuklarda beklenmekte olup bu grup, söz konusu koruyucu strateji için öncelikli hedef popülasyonu oluşturabilir.

Anahtar Kelimeler

• OM-85
• Tekrarlayan Solunum Yolu Enfeksiyonu
• Atopi
• İmmünglobulin

Destekleyen Kurum

Yazarlar bu çalışma için herhangi bir mali destek almadıklarını beyan etmişlerdir.

Etik Beyan

Etik Kurul Onayı Bilgileri: Onaylayan Kurul: Sağlık Bilimleri Üniversitesi, Bursa Tıp Fakültesi ve Bursa Şehir Hastanesi Onay Tarihi: 05.02.2025 Karar No: 2025-3/1

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