What criteria determine if a patient is an appropriate candidate for Dupixent (dupilumab) therapy?

Determining Dupilumab Candidacy

Initiate dupilumab in patients with moderate-to-severe disease who have failed at least 4 weeks of optimized intranasal corticosteroids (for CRSwNP), or optimized topical therapy (for atopic dermatitis), or remain uncontrolled on inhaled corticosteroids (for asthma), with preference for patients showing type 2 inflammatory markers. 1, 2, 3

Disease-Specific Candidacy Criteria

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Primary Candidates:

• Severe nasal polyp disease (nasal polyp score ≥6 on 0-8 scale) with inadequate control despite intranasal corticosteroids for at least 4 weeks 1, 2, 3
• Prior sinus surgery (63% of trial patients had previous surgery, mean 2.0 prior surgeries) or patients who are surgical candidates but prefer medical management 3
• Recent systemic corticosteroid use (patients requiring 1-2 courses in previous 2 years) or those intolerant to systemic corticosteroids 3
• Sinus opacification on CT scan documented by Lund-Mackay scoring 3

Optimal Candidates (Prioritize These):

• High baseline disease burden with SNOT-22 scores indicating severe quality of life impairment 2
• Comorbid atopic dermatitis providing dual indication for dupilumab 2
• Comorbid asthma (59% of trial patients) or NSAID-exacerbated respiratory disease (28% of trial patients) 3

Atopic Dermatitis (AD)

Primary Candidates:

• Moderate-to-severe AD defined by Investigator's Global Assessment (IGA) score ≥3 on 0-4 scale 1, 3
• EASI score ≥16 on 0-72 scale at baseline 3
• Body surface area involvement ≥10% 3
• Inadequate control with topical prescription therapies (topical corticosteroids and/or topical calcineurin inhibitors) or when those therapies are not advisable 1, 4

Clinical Context:

• Dupilumab is the first-line systemic agent favored by all guideline workgroup members surveyed 1
• Can be used as monotherapy or with concomitant topical corticosteroids 3

Asthma

Primary Candidates:

• Moderate-to-severe asthma uncontrolled on inhaled corticosteroids 5, 6
• Type 2 inflammatory phenotype indicated by:
  • Baseline blood eosinophils ≥300 cells/mcL (primary analysis population) 3
  • Elevated FeNO ≥20 ppb 3
  • History of ≥2 exacerbations in previous year 3

Important Caveat:

• In patients with baseline blood eosinophil count <150 cells/mcL and FeNO <20 ppb, similar exacerbation rates were observed between dupilumab and placebo—these patients are poor candidates 3

Key Biomarkers and Clinical Features

Type 2 Inflammation Markers (Strongest Predictors)

• Elevated blood eosinophils (≥300 cells/mcL for asthma; mean 502 cells/mcL in pediatric trials) 3
• Elevated total IgE (median 792 IU/mL in pediatric asthma trials; particularly relevant if considering omalizumab as alternative) 2, 3
• Elevated FeNO (≥20 ppb; mean 28 ppb in trials) 3

Comorbidity Patterns That Strengthen Candidacy

• Multiple atopic conditions (92% of pediatric asthma patients had atopic medical history; 36% had AD, 82% had allergic rhinitis) 3
• Dual or triple indication (e.g., CRSwNP + asthma + atopic dermatitis) 2, 3

Patients to Avoid or Consider Alternatives

Contraindications and Poor Candidates

• Patients who haven't tried intranasal corticosteroids for at least 4 weeks (for CRSwNP)—this violates the conditional nature of guideline recommendations 2
• Asthma patients without type 2 inflammatory markers (eosinophils <150 cells/mcL and FeNO <20 ppb) show no benefit 3
• Chronic rhinosinusitis without nasal polyps—these patients were not included in trials and lack efficacy data 3

Consider Alternative Biologics When

• Female patients planning pregnancy in near future—omalizumab is preferred as it has pregnancy data 7
• Highly eosinophilic asthma as primary concern—mepolizumab may be indicated 7
• Elevated IgE with allergic asthma—omalizumab represents ideal population 2

Pre-Treatment Assessment Checklist

Before initiating dupilumab, document:

1. Disease severity scores (SNOT-22 for CRSwNP, IGA/EASI for AD, ACQ for asthma) 3
2. Baseline eosinophil count and FeNO (for asthma/CRSwNP) 3
3. Prior treatment failures including duration and adequacy of topical/intranasal corticosteroid use 2, 3
4. Imaging documentation (CT scan with Lund-Mackay scoring for CRSwNP) 3
5. Comorbid conditions (asthma, atopic dermatitis, allergic rhinitis, NSAID-ERD) 3
6. Prior surgical history (for CRSwNP) 3

Common Pitfalls to Avoid

• Don't assume tezepelumab has equivalent evidence to dupilumab for CRSwNP—it lacks the same level of data 2
• Don't initiate in low type 2 inflammation asthma—patients without elevated eosinophils or FeNO show no benefit 3
• Don't skip optimization of basic therapy first—ensure proper intranasal corticosteroid technique and adherence before escalating 7
• Monitor for conjunctivitis—while rare in CRSwNP/asthma trials (unlike atopic dermatitis trials), it remains a potential adverse effect requiring monitoring 1
• Transient eosinophilia occurs in 11.3% of patients but rarely causes persistent problems or requires discontinuation; most cases resolve while continuing therapy 8

Safety Monitoring

Common adverse effects to counsel patients about:

• Conjunctivitis (2.8% in real-world respiratory disease cohort) 8
• Injection-site reactions 1, 8
• Arthralgias (5.2%) 8
• Nasopharyngitis (more frequent with placebo in CRSwNP trials) 1

Serious but rare concerns:

• Eosinophilic granulomatous polyangiitis (extremely rare; one case in 251 patients) 8
• Serum sickness or serum sickness-like reactions (two cases in AD trials with high titer antibodies) 3