Clinical remission in patients with severe eosinophilic asthma treated with benralizumab over 24 months: Post hoc analysis of the ANANKE study.

Background: Clinical remission is an emerging treatment goal in severe eosinophilic asthma (SEA). While benralizumab, an anti-IL-5Rα monoclonal antibody, has demonstrated efficacy in SEA, its ability to induce clinical remission in real-life settings over extended follow-up remains underexplored. Methods: This post hoc analysis of the multicenter, retrospective ANANKE study evaluated clinical remission over 24 months in 167 Italian patients with SEA treated with benralizumab. Remission was defined according to the Severe Asthma Network Italy (SANI) criteria. Complete clinical remission (cCR) required the absence of oral corticosteroid (OCS) use and the presence of 3 criteria: no symptoms, no exacerbations, and stable lung function. Partial clinical remission (pCR) required the absence of OCS use and 2 of the 3 criteria. Outcomes were assessed at 3, 12, and 24 months. Results: The proportion of patients achieving clinical remission increased over time: 87.2% at 3 months (40.4% pCR, 46.8% cCR), 95.0% at 12 months (17.5% pCR, 77.5% cCR), and 96.1% at 24 months (23.5% pCR, 72.6% cCR). No baseline demographic or clinical characteristics were found to significantly predict remission status. Blood eosinophil counts declined from a mean of 476.7 to 5.2 cells/μL at 24 months. Conclusion: In this real-world Italian cohort, benralizumab was associated with rapid and sustained clinical remission in patients with SEA over 24 months. The high remission rates observed early and maintained throughout treatment support the role of benralizumab as a disease-modifying therapy and reinforce clinical remission as a meaningful therapeutic goal in SEA.