Benralizumab, known commercially as Fasenra, emerges as a promising treatment for nasal polyps by targeting eosinophilic inflammation, a key factor in severe eosinophilic asthma and chronic rhinosinusitis. Clinical trials highlight its efficacy in reducing polyp size and nasal blockage, while ongoing research and real-world studies continue to explore its potential benefits and safety profile.
Understanding Benralizumab and Its Role in Treating Nasal Polyps
Benralizumab, marketed as Fasenra by AstraZeneca, is a monoclonal antibody that targets the IL-5 receptor-α, leading to rapid and sustained eosinophil depletion. This mechanism is crucial in managing type 2 (T2) inflammation underlying severe eosinophilic asthma (SEA) and chronic rhinosinusitis with nasal polyps (CRSwNP) (source). The drug’s ability to reduce eosinophil levels makes it a promising treatment for nasal polyps, which are often associated with eosinophilic inflammation.
Clinical Trials and Efficacy of Benralizumab
The phase 3 OSTRO trial demonstrated that benralizumab significantly improved nasal polyp size and nasal blockage in patients with CRSwNP. This trial involved 413 adult patients with severe nasal polyposis who were symptomatic despite standard care, including intranasal corticosteroids and prior surgeries (source). Patients were randomized to receive benralizumab 30mg subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks, or a placebo. Statistically significant improvements were observed in both the endoscopic total nasal polyp score (NPS) and mean nasal blockage score (NBS) at week 40 for those treated with benralizumab compared to placebo, indicating its potential as a treatment option (source).
Safety and Approval Status
Benralizumab’s safety profile was consistent with known data, reinforcing its viability as a treatment for nasal polyps without introducing new safety concerns (source). However, the FDA issued a complete response letter (CRL) for AstraZeneca’s supplemental Biologics License Application (sBLA) for Fasenra targeting CRSwNP, requesting additional clinical data to support its approval. The ongoing ORCHID Phase III trial is evaluating Fasenra’s efficacy and safety in patients with eosinophilic CRSwNP, with results expected in the second half of 2023, which could provide the additional data needed for FDA approval (source).
Real-World Implications and Future Directions
Real-world studies, including the RANS and MEGA studies, support the clinical trial findings, showing significant improvements in CRSwNP severity and asthma control metrics in patients treated with benralizumab (source). The presence of CRSwNP was identified as a predictor of enhanced efficacy of benralizumab, with CRSwNP patients achieving better asthma control and higher proportions of well-controlled asthma at all time points compared to No-CRSwNP patients (source). This suggests that benralizumab may offer a rapid onset of action and superior efficacy in patients with CRSwNP.
Why You Should Learn More About Benralizumab for Nasal Polyps Today
Benralizumab represents a significant advancement in the treatment of nasal polyps, particularly for patients with co-morbid conditions like severe eosinophilic asthma. Its ability to target eosinophilic inflammation offers a promising alternative to traditional treatments, which often provide only short-term relief. As ongoing trials continue to evaluate its efficacy and safety, benralizumab may soon become a cornerstone in the management of nasal polyps. Understanding its potential benefits and staying informed about the latest research can help patients and healthcare providers make more informed decisions about treatment options.