D1.154 - Safety of ultra-rush immunotherapy starting protocol with the molecular extract Diater Alt a 1 mol mix

Molecular and precision medicine are transforming allergy management, offering highly targeted therapies. Immunotherapy using molecular extracts is now available, with proven safety in conventional protocols (manufacturer-recommended Figure1). However, its safety under ultra-rush initiation remains uncertain. 

Our objective was to evaluate the safety of the molecular extract Diater Alt a 1 Mol Mix under an ultra-rush initiation protocol in patients from Seville, Spain, with rhinoconjunctivitis, with or without asthma, allergic to Alternaria, pollens (grass and olive), and/or mites.

We conducted a prospective observational study with patients starting immunotherapy between October 2023 and May 2024. The ultra-rush protocol consisted of 0.2 mL SC in one arm and 0.3 mL SC in the other, separated by a 30-minute observation period (Figure1). The maintenance dose (0.5 mL, divide in two arms) was administered after one month. Demographic, clinical, and analytical variables were collected, and adverse events were self-reported.

A total of 45 patients (55% male) initiated immunotherapy, aged 6 to 52 years (mean age: 18 years). All had rhinoconjunctivitis; five had asthma confirmed by spirometry, and 27 reported asthma-like symptoms but with normal or unperformed spirometry.

All patients were sensitized to Alternaria alternata, pollens, and/or mites, with varying patterns (Figure 2). Serum total IgE ranged from 21.2 to 1550 IU/mL (mean: 359.22 IU/mL), specific IgE range is shown in Table 1. Ten patients had specific IgE levels >100 IU/mL: two for Ole e 1, three for Ole e 7, one for Ole e 1 and Ole e 9, and four for Alt a 1.

Of the prescribed immunotherapy, 68.9% was for two allergens (Alt a 1 + grass/olive pollen or mites), and 31.1% for three allergens (Alt a 1 + grass and olive pollen). No adverse events occurred.

Using an ultra-rush initiation protocol, this observational study, demonstrated a favorable safety profile and time-saver strategy, with no adverse events. Despite the small sample size, the findings are clinically significant and representative of our population.