What are the indications to start biologics (biologic medications) therapy in chronic rhinosinusitis (CRS) with nasal polyps?

Indications to Start Biologics Therapy in Chronic Rhinosinusitis with Nasal Polyps

Biologics therapy should be initiated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have high disease burden despite standard treatments, particularly those with inadequately controlled symptoms after using intranasal corticosteroids for at least 4 weeks or who have severe disease at initial presentation. 1

Primary Indications for Biologic Therapy

• Inadequate response to first-line treatments: Patients who have not sufficiently benefited from other treatments including intranasal corticosteroids (INCS), surgery, or aspirin treatment after desensitization (ATAD) in those with aspirin-exacerbated respiratory disease (AERD) 1

• High baseline disease severity: Patients with severe symptoms and significant polyp burden at presentation may benefit from earlier initiation of biologics rather than trying less effective therapies 1

• Continued high disease burden: Despite using INCS for at least 4 weeks, patients who continue to experience significant symptoms should be considered for biologic therapy 1

• Comorbid conditions: Patients with type 2 inflammatory comorbidities that also have indications for biologic therapy, such as:

  • Moderate-to-severe asthma 1
  • Atopic dermatitis (particularly for dupilumab) 1
  • Eosinophilic granulomatosis with polyangiitis (EGPA) (particularly for mepolizumab) 2, 1

Patient Selection Considerations

• Type 2 inflammatory pattern: Most CRSwNP in Western countries (approximately 85%) demonstrates a type 2 inflammatory pattern, which is the target of available biologics 3

• AERD patients: Biologics may be preferred over ATAD in patients with AERD who have:

  • Increased risk of bleeding complications (history of GI bleeding, prednisone use, hypertension, diabetes, smoking, male sex, lower weight/BMI) 1
  • Desire to avoid strict daily oral medication regimen and initial desensitization procedure 1

• Frequent need for systemic corticosteroids: Patients requiring oral steroids more than once every 2 years (or once yearly in those with comorbid asthma) may benefit from biologics to reduce steroid exposure 1

• History of multiple surgeries: Patients with recurrent polyps after previous surgical interventions 4, 5

Specific Biologic Selection

• Dupilumab (anti-IL-4Rα): First biologic approved for CRSwNP; shows greatest improvement in disease-specific quality of life (SNOT-22 score) and nasal symptoms; particularly beneficial for patients with comorbid atopic dermatitis 1, 6

• Omalizumab (anti-IgE): Shows significant benefits for patient-important outcomes; may be preferred in patients with allergic components 1

• Mepolizumab (anti-IL-5): Approved for CRSwNP; particularly beneficial in patients with comorbid EGPA or hypereosinophilic syndrome 2, 1

Practical Considerations

• Insurance and cost barriers: Patients who value not having the burden of payment and insurance approvals may be less likely to choose biologics 1

• Administration route: All approved biologics require parenteral (subcutaneous) administration, which may influence patient preference 1, 4

• Monitoring requirements: Regular follow-up to assess response is needed, with evaluation of symptom improvement, polyp size reduction, and quality of life measures 7, 4

Cautions and Pitfalls

• Not all patients require biologics: Patients with low disease burden who have not tried other therapies might prefer to avoid systemic therapy with biologics 1

• Lack of biomarkers: Currently, there are no validated biomarkers to predict response to specific biologics or to monitor treatment success 3

• Long-term safety considerations: While short-term safety profiles are favorable, long-term data continues to emerge 4

• Treatment duration: Optimal duration of therapy remains undefined; some patients may require indefinite treatment 1, 4