OM-85 add-on therapy significantly reduces asthma exacerbations and corticosteroid dependence in patients with difficult-to-control T2-high asthma.
Adults with difficult-to-treat T2-high asthma who experience frequent flare-ups may benefit from add-on treatment with the bacterial lysate OM-85, according to findings from the OMREXA real-world study.
Patients with T2-high asthma often continue to experience recurrent exacerbations despite receiving guideline-directed standard therapy, leading to increased corticosteroid exposure and disease burden. OM-85, a polyvalent bacterial lysate with immunomodulatory and airway-protective properties, has gained attention for its potential role in reducing respiratory infections and improving asthma control. Its ability to enhance epithelial defense mechanisms and regulate inflammatory responses may offer additional therapeutic value in difficult-to-treat asthma.
A group of researchers conducted a secondary post-hoc analysis to determine whether the addition of OM-85 to standard asthma therapy diminished exacerbation frequency and oral corticosteroid (OCS) use. They used data derived from the OMRIA real-world study. Overall, 137 adults diagnosed with frequently exacerbating T2-high asthma who remained on standard asthma management were included. Participants received either standard of care alone or add-on OM-85 administered in two separate 3-month treatment cycles with an intervening treatment-free interval.
Patients were followed over a 12-month period, during which asthma exacerbations and OCS bursts were systematically recorded. Exacerbations were further categorized into non-infectious and infectious clinical subtypes for comparative assessment. Patients treated with OM-85 in combination with standard therapy experienced prominent reductions in overall asthma exacerbations and OCS bursts compared with those receiving standard care alone. Statistical analyses adjusted using propensity score weighting verified the robustness of these findings.
Reductions were witnessed across all exacerbation categories, including non-infectious asthma symptom episodes and infection-associated exacerbations (Table 1).

The most pronounced decline was reported in severe infectious exacerbations linked to bronchitis, sinusitis, or pneumonia symptoms. Safety outcomes remained comparable between treatment groups throughout the observation period. The analysis concluded that adjunctive OM-85 therapy contributed to meaningful reductions in asthma exacerbation burden and corticosteroid dependence among adults with difficult-to-control T2-high asthma. These findings supported the consideration of OM-85 as a complementary strategy for those who continue to experience frequent exacerbations despite optimized standard care.
Respiratory Medicine
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
Maria Elpida Christopoulou et al.
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