Long-Term Effectiveness and Safety of Paediatric Cow’s Milk Oral Immunotherapy in Real Life: Outcomes With and Without Omalizumab Support

Presenter: M. Niegowska

This retrospective study assessed the long-term effectiveness and safety of cow’s milk oral immunotherapy (CM-OIT) in 104 children and adolescents with persistent cow’s milk allergy, including patients treated with omalizumab. Follow-up extended up to 17 years (mean: 6.52 years), and 70.2% of patients had a history of anaphylaxis before treatment. The mean up-dosing period was 5.77 months. At the last follow-up, 92 patients (88.5%) tolerated cow’s milk. Of these, 74 (71.2%) tolerated 200 mL/day, 3 (2.9%) were on a free diet, and 15 (14.4%) maintained a reduced dose. CM-OIT was discontinued in 12 patients (11.5%). Among the 35 patients receiving omalizumab, treatment could be discontinued in 28.6%, reduced in 34.3%, restarted in 5.7%, and continued in 31.4%. Post-OIT anaphylaxis occurred in 17 patients (16.3%), resulting in 26 episodes and 29 emergency visits. Casein-specific immunoglobulin E (IgE) levels decreased from 37.98 to 19.96 kU/L, while the casein/total IgE ratio decreased from 9.9% to 4.92% after treatment. A higher baseline casein/total IgE ratio was associated with post-OIT anaphylaxis (P<0.001), the need for milk dose reduction (P=0.018), and a longer up-dosing period (r=0.34; P=0.001). No patient with a ratio below 3.69% required dose reduction.

Overall, CM-OIT showed high long-term effectiveness with acceptable safety, including in higher-risk patients receiving omalizumab. The baseline casein/total IgE ratio may help identify patients at increased risk of treatment-related reactions.

Real-World Comparison of Mepolizumab and Omalizumab in CRSwNP: Impact of Baseline Phenotypic Complexity

Presenter: OT. Seren

This retrospective study compared the effectiveness of mepolizumab and omalizumab in patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) over 8 months. The study also evaluated whether differences in baseline disease characteristics influenced treatment outcomes. A total of 64 patients received either mepolizumab (n=36) or omalizumab (n=28). Clinical outcomes were assessed at baseline, 4 months, and 8 months using the Sino-Nasal Outcome Test-22 (SNOT-22) and visual analogue scale (VAS) symptom scores. Both treatments produced significant improvements in symptoms from baseline to month 4 (P<0.001), with benefits maintained through month 8 and no significant additional improvement after month 4 (P>0.05). Patients receiving mepolizumab had more complex disease at baseline, with a higher prevalence of asthma (58.3% vs 28.6%; P=0.024), nonsteroidal anti-inflammatory drug-exacerbated respiratory disease (NERD) (50.0% vs 21.4%; P=0.022), and higher blood eosinophil counts (0.495 vs 0.285 ×10⁹/L; P=0.017) compared with the omalizumab group. At 8 months, patients treated with omalizumab showed greater improvement in SNOT-22 scores than those receiving mepolizumab (median improvement: 31.0 vs 14.0; P=0.029). Omalizumab was also associated with greater improvement in selected symptoms, including nasal congestion, postnasal drip, and sneezing (all P<0.05).

Overall, both mepolizumab and omalizumab provided rapid and sustained symptom improvement in patients with severe CRSwNP. The greater improvement observed with omalizumab may be influenced by differences in baseline disease complexity between the treatment groups.

Efficacy, Safety, and Remission Outcomes of Omalizumab in Elderly Patients with Severe Allergic Asthma: A Subgroup Analysis by Age of Onset

Presenter: E. Atayik

This retrospective study evaluated the effectiveness, safety, and remission outcomes of omalizumab in elderly patients (≥65 years) with severe allergic asthma. Treatment outcomes were also compared between patients with early-onset asthma (<45 years) and late-onset asthma (≥45 years). The study included 44 patients with a median age of 68 years, of whom 70.5% were female. All patients received omalizumab for at least 12 months. Clinical outcomes assessed included asthma control, lung function, oral corticosteroid use, exacerbations, hospitalizations, and remission status. After 12 months of treatment, 75% of patients achieved a clinical response and 54.5% achieved clinical remission. Asthma Control Test (ACT) scores improved significantly from a median of 14 to 22 (P<0.001). Lung function also improved, with forced expiratory volume in 1 second (FEV₁) increasing from 59.5% to 77.5% of predicted values (P<0.001). Oral corticosteroid use decreased significantly from a median of 8 mg to 0 mg (P<0.001). Clinical remission was achieved by 69.2% of patients with early-onset asthma and 48.4% of those with late-onset asthma; however, the difference was not statistically significant (P=0.205). No serious adverse events were reported during treatment.

Overall, omalizumab was associated with improved asthma control, better lung function, reduced corticosteroid use, and clinical remission in more than half of elderly patients with severe allergic asthma, with a favourable safety profile.

Safety of Omalizumab in Children 1 to 5 Years of Age with Multiple Food Allergies

Presenter: E. Kim

This analysis evaluated the safety of omalizumab in children aged 1–5 years with multiple food allergies enrolled in the OUtMATCH trial (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults). Safety outcomes were assessed in participants who received at least one dose of omalizumab or placebo. A total of 61 children were included, with 41 receiving omalizumab and 20 receiving placebo. Adverse events (AEs) were reported in 68.3% of children in the omalizumab group and 80.0% of those receiving placebo. Treatment-related or possibly treatment-related AEs occurred in 21.9% (9/41) of children receiving omalizumab and 20.0% (4/20) of those receiving placebo. Six episodes of anaphylaxis occurred in four participants. Three episodes occurred in the placebo group (Grade 2 and 3) and one in the omalizumab group (Grade 2). Four episodes occurred during double-blind, placebo-controlled food challenges and two occurred outside of these challenges. None of the anaphylaxis episodes were considered related to omalizumab. One child receiving omalizumab discontinued treatment because of elevated liver function test results, which was considered a serious adverse event possibly related to treatment. No such events occurred in the placebo group. Most adverse events in both groups were mild (Grade 1), and no Grade 4 (life-threatening) or Grade 5 (fatal) adverse events were reported.

Overall, the safety profile of omalizumab in children aged 1–5 years was similar to that observed with placebo and was consistent with the established safety profile of omalizumab in older children and adults.

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