Benralizumab shows real-world efficacy for severe asthma regardless of nasal polyps

Benralizumab appeared effective for severe eosinophilic asthma in a real-world study of patients with and without chronic rhinosinusitis with nasal polyps, according to data published in The Journal of Allergy and Clinical Immunology.

Chronic rhinosinusitis with nasal polyposis (CRSwNP) affects approximately 40% to 60% of patients with severe eosinophilic asthma (SEA).

CRSwNP has a high impact on symptom control and exacerbation risk, which can contribute to the socioeconomic burden of SEA due to the need for repeated functional endoscopic sinus surgery.

Benralizumab (Fasenra, AstraZeneca), a humanized IgG1k monoclonal antibody, has shown efficacy in the treatment of SEA, as demonstrated by a reduction in asthma exacerbations and oral corticosteroid (OCS) use and improved airflow limitation and asthma control.

To analyze whether this benefit of benralizumab persisted among patients with SEA and CRSwNP, Santi Nolasco, MD, of the department of clinical and experimental medicine at University of Catania in Italy, and colleagues conducted a real-world multicenter observational study that included 137 patients (average age, 53.9 years; standard deviation, 13.5 years; 66.4% women) who had received benralizumab for at least 24 weeks. Of these, 58 patients had SEA and 79 had SEA and CRSwNP.

Researchers evaluated patients with the 22-item Sino-Nasal Outcome Test (SNOT-22) at baseline and at 24 weeks. Patients’ asthma exacerbations, Asthma Control Test (ACT) score, lung function, OCS dosage, and eosinophil and basophil count in peripheral blood were recorded at baseline, 4 weeks, 12 weeks and 24 weeks.

The 79 patients with CRSwNP had a median SNOT-22 score of 46 at baseline, which decreased to 32 at week 24 (P < .0001).

The annual exacerbation rate decreased from an average of 4 to 0 (P < .0001). This correlated with an improvement in ACT score from an average of 13 at baseline to 20 after the first dose at 4 weeks and to 22 at 24 weeks (P < .0001 for both).

At week 24, a greater proportion of patients with CRSwNP than SEA alone achieved the ACT minimally clinically important difference, measured by an increase of at least three points from baseline (92.4% vs. 79.3%; P = .0387).

The researchers observed parallel improvements in lung function for forced expiratory volume in the 1st second (FEV₁) and forced vital capacity (FVC) scores as early as 4 weeks in pre-bronchodilator FEV₁%, FEV₁ (L), FVC% and FEV₁/FVC% (P < .0001 for all). FEF_25-75% — which measures small airways obstruction associated with nasal polyps — shifted from an average of 38% to 41% after 4 weeks (P = .0022), reaching 55% after 24 weeks (P < .0001).

Among the 59.1% of patients who required maintenance OCS at baseline, Nolasco and colleagues observed a median dosage reduction at 24 weeks from 10 mg to 0 mg. Additionally, 70.4% were able to discontinue their maintenance OCS (P < .0001).

“To date, personalized treatment for patients diagnosed with SEA is one of the most significant advances in modern care for asthma,” Nolasco and colleagues wrote. “These findings confirm that benralizumab is a valuable therapeutic choice for patients suffering from SEA, particularly if associated with nasal polyps, in which the biologic may determine synergistic beneficial effects for both diseases.”