The bacterial lysate OM-85 reduces exacerbations and oral corticosteroid use in frequently exacerbating patients with T2-High asthma: The OMREXA real-world evidence study

BACKGROUND: Underlying immune modifications are offered by the Polyvalent Chemical Bacterial Lysate OM-85 (i.e., anti-viral properties, enhancement of the epithelium barrier function, and induction of a tolerance landscape in the lungs). This secondary post hoc analysis used data from the OMRIA study, to assess the effect of add-on OM-85 on reducing the risk for exacerbations of any origin in adults with difficult-to-treat T2-high asthma. METHODS: The Oral Bacterial Lysate OM-85 Prevents Respiratory Tract Infections in Asthma (OMRIA) study enrolled adults with T2-high asthma frequently exacerbating, under standard of care asthma therapy (SoC), who were started on OM-85 (two 3-month courses with a 3-month treatment-off period in between). Patients were assigned to two groups (OM-85 plus SoC n = 70 and SoC group n = 67) and all AEXs and OCS bursts were recorded throughout a 12-month period. A clinical categorization to identify infectious and non-infectious AEXs was also applied: 1. Asthma symptoms alone (non-infectious), 2. Combined asthma and common cold symptoms (infectious), 3. Combined asthma and bronchitis, sinusitis, or pneumonia symptoms (infectious). RESULTS: The weighted with propensity scores analyses (Poisson and negative binomial regression model), verified the statistically significant decreases in the average numbers of AEXs and OCS bursts reported in OMRIA study, in patients treated with OM-85. Same tendencies were recorded in each AEX class (class 1-non-infectious: 50.5% decrease, classes 2 and 3-infectious: 72.2% and 89.8% decrease, respectively). CONCLUSION: This secondary post hoc analysis supports the therapeutic benefit of OM-85 in patients with T2-high asthma who have frequent exacerbations despite adherence to SoC asthma therapy.