D3.192 - Safety of AIT with Depigmented-polymerized extracts in patients with severe allergic asthma. A subanalysis of the SAGITAL study

Asthma is a chronic inflammatory disease with variable airflow obstruction. Although AIT is effective for mild to moderate allergic asthma, it is contraindicated in uncontrolled disease and its safety in well-controlled severe asthma (SAA) remains uncertain. Depigmentation-polymerization of extracts for immunotherapy increases their purity and safety.

A sub-analysis was performed using data from the retrospective SAGITAL study. It included patients aged >6 years with SAA (GEMA stage 5/6, GINA stage 5) sensitized to at least one allergen, treated with different Depigoid formulations at 10 Spanish centers over the past three years. The study evaluated the frequency and severity of adverse reactions (ARs) during AIT, classified according to the 2010 WAO system.

Twenty patients with well-controlled severe asthma received Depigoid extracts. Sixty percent were women, and the median age was 41.9 years (three patients <14 years). Five patients were receiving biologic therapy. Three adverse reactions occurred in three patients (16%), all local reactions during the first administration: one mild and immediate, and two delayed (one mild, one moderate). No reactions occurred in patients on biologics, and no medication was required.

Although not statistically significant (p=0.26), forced expiratory volume in one second (FEV₁) improved by 10% after three years of AIT. Fractional exhaled nitric oxide (FeNO) decreased by 50%. Asthma Control Test (ACT) scores indicated good asthma control throughout treatment (mean: 21).

This study shows a favourable safety profile of AIT with Depigoid in well-controlled SAA in routine clinical practice. Although effectiveness was not objective, improvements in respiratory function were observed. Under strict medical supervision, selected patients may benefit from AIT. Further real-world studies are needed to clarify its effectiveness in SAA.