Pathway to Remission in Severe Asthma: Clinical Effectiveness and Key Predictors of Success with Benralizumab Therapy: A Real-Life Study.

Recent data indicate that approximately 10-20% of patients with severe asthma (SA) receiving benralizumab (BENRA) do not achieve the desired outcomes. Emerging evidence suggests that clinical remission (CRem) is possible with biologics, warranting investigations into predictive factors. In this retrospective, single-center study, we analyzed 103 SA patients treated with BENRA for 12 months. CRem was defined as meeting four criteria: no exacerbations requiring oral corticosteroids (OCSs), discontinuation of chronic OCS therapy, improvement in FEV1 ≥100 mL, and an ACQ score < 1.5. Logistic regression identified predictors of remission. After 12 months, 33% of patients achieved CRem, while 10% discontinued treatment due to lack of improvement. BENRA reduced the annual exacerbation rate from a median of 2 to 0 ( < 0.0001) and eliminated OCS use in 80% of patients. Lung function improved significantly, with a +13.5% predicted increase in FEV1 ( < 0.0001). Asthma control also improved, with ACQ scores decreasing from 3.2 to 1.5 ( < 0.0001) and mini-AQLQ scores increasing from 3.4 to 5.0 ( < 0.0001). Key predictors of remission included baseline eosinophil count ≥740 × 10/μL (OR = 3.91, = 0.02), SA duration (OR = 0.90, = 0.02), baseline quality of life (OR = 2.18, = 0.04), and pre-treatment FEV1 (OR = 1.07, = 0.005). The logistic regression model for these parameters showed strong predictive accuracy (AUC = 0.855, 95% CI 0.78-0.93). Importantly, the SA phase, rather than total asthma duration, was the critical factor, with each additional year reducing the odds of remission by ~10%. Clinical remission is a realistic goal in severe asthma, and early initiation of biologic therapy is vital for improving remission rates and long-term outcomes.