Immunological parameters as biomarkers of response to MicroCrystalline Tyrosine-adjuvanted mite immunotherapy.

BACKGROUND: Despite the effectiveness of allergen immunotherapy (AIT), some patients are unresponsive for reasons still unknown; yet validated response biomarkers remain unavailable. OBJECTIVE: To analyze immunological parameters as biomarkers to monitor and predict clinical response to a MicroCrystalline Tyrosine-adjuvanted house dust mite (HDM) AIT in patients with allergic rhinitis (AR). METHODS: Observational, prospective, multicenter study including adult patients (aged 18-65 years) with AR, with and without asthma, sensitized to the HDM Dermatophagoides pteronyssinus (DP) and prescribed Acarovac Plus® DP 100% in the routine practice. Serum concentrations of total IgE, specific IgE, specific IgG4, IL-4, IL-5, IL-10, IL-13, and IFN-γ were compared between baseline and 12 months after AIT. The relationship between patients' baseline immunological profiles and classification as low, high, and non-responders and between their sensitization profile to DP allergens and effectiveness were analyzed. RESULTS: Of 141 patients recruited, 118 (mean [SD] age of 33.6 [9.5] years) were evaluable. One year after treatment, Der p 1-specific IgE, DP-specific IgG4, and IL-10 increased by a mean (SD) of 3.4 (13.6) kU/L (p = 0.016), 0.43 (0.55) mg/L (p < 0.0001), and 1.35 (7.56) pg/mL (p = 0.033), respectively. Non-responders showed increased baseline levels of IL-13 compared to high responders (p = 0.037). Changes in effectiveness variables between baseline and after AIT were similar regardless of the sensitization profile. CONCLUSION: Non-responsive patients to AIT showed increased baseline IL-13 concentrations, suggesting its value as prognostic biomarker. DP-specific AIT increased Der p 1-specific IgE, DP-specific IgG4, and IL-10 concentrations in patients with AR. All patients benefited from treatment regardless of their sensitization profile to major DP allergens.

Real-life effect of a microcrystalline tyrosine adjuvanted mite immunotherapy in patients with allergic rhinitis.

Aim: Evaluate the effectiveness and safety of immunotherapy with Acarovac Plus® in a 1-year prospective multicentered real-life study. Methods: A total of 118 adults with allergic rhinitis sensitized to Dermatophagoides received subcutaneous immunotherapy with Acarovac Plus. Treatment outcomes were evaluated at baseline, 6 months and 1 year after treatment initiation. Primary end point was the evolution of the combined symptom and medication score. Secondary end points included other effectiveness outcomes and measurement of product tolerability. Results: Acarovac Plus induced significant improvements in primary and secondary end points after 6 months compared with baseline. These differences persisted after 1 year of treatment (p < 0.001; baseline vs 1 year): combined symptom and medication score (1.60 vs 0.79). No serious adverse events were recorded. Conclusion: Acarovac Plus for 1 year was effective and well tolerated in a real-life setting.

Observational study of the safety of an ultra-rush sublingual immunotherapy regimen to treat rhinitis due to house dust mites.

BACKGROUND: Ultra-rush regimens for administering sublingual immunotherapy to patients with allergies are becoming more widespread. We aimed to assess treatment safety for patients with allergic rhinitis with or without asthma caused by Dermatophagoides house dust mites. METHODS: This observational study at 5 Spanish centers included 218 patients aged 4-64 years, of whom 117 were women and 122 were under 15 years old. Ultra-rush regimen consisted of incremental doses of an allergen extract comprising a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (30, 60, 120, 240 IR every 30 min) followed by maintenance therapy. Adverse reactions were monitored and asthmatic patients underwent spirometric testing at baseline and after each dose. Follow-up was scheduled after 2 weeks of maintenance with 240 IR three times a week. RESULTS: Five patients had to modify ultra-rush regimen because of mild local adverse reactions. In total, 32 adverse reactions were reported in 27 patients during the ultra-rush regimen. Seven of these events were local gastrointestinal reactions, and the remaining 17 were local reactions, mainly labial or mouth itching and burning. Eight events were systemic reactions [rhinitis (n = 3), general malaise (n = 1), general malaise and vomiting (n = 1), dizziness (n = 1), asthma (n = 1), dyspnea (n = 1)]. All adverse reactions were mild or moderate. Serious adverse events or life-threatening anaphylactic reactions were not reported. CONCLUSIONS: High-dose sublingual immunotherapy with Dermatophagoides allergen extracts can be safely administered in an ultra-rush regimen, although its usefulness and benefit for perennial allergens (e.g. house dust mites) must be evaluated.