Tezepelumab (Tezspire) for COPD
Tezepelumab is not currently approved for COPD and should not be used as standard therapy, as it failed to meet its primary endpoint in reducing COPD exacerbations in the overall population. 1
Current Evidence and Regulatory Status
Tezepelumab is FDA-approved only for severe asthma, not for COPD. 2 The COURSE trial, a phase 2a randomized controlled trial in patients with moderate to very severe COPD on triple inhaled therapy, demonstrated:
No significant reduction in exacerbations overall: The annualised exacerbation rate was 1.75 with tezepelumab versus 2.11 with placebo (rate ratio 0.83, p=0.10), failing to meet the primary endpoint. 1
Potential benefit in high eosinophil subgroups: In patients with baseline blood eosinophils ≥300 cells/μL, the exacerbation rate was 1.20 versus 2.24 with placebo (rate ratio 0.54), though this was a prespecified subgroup analysis. 1
Safety profile was acceptable: Tezepelumab was well tolerated with no new safety concerns identified. 1
Evidence-Based COPD Management
Current COPD guidelines do not include tezepelumab or other biologics as recommended therapy. 3 Standard pharmacological management includes:
Inhaled bronchodilators (long-acting anticholinergics or long-acting β-agonists) are strongly recommended for symptomatic patients with FEV1 <60% predicted. 3
Combination inhaled therapies may be considered for symptomatic patients with FEV1 <60% predicted. 3
Inhaled corticosteroids are recommended for severe COPD with frequent exacerbations (≥2 per year) and FEV1 <50% predicted. 4
Special Consideration: Asthma-COPD Overlap
The only clinical scenario where tezepelumab might be considered is in patients with both asthma and COPD (asthma-COPD overlap syndrome), characterized by:
- High type 2 biomarkers (blood eosinophils ≥300 cells/μL and/or FeNO ≥50 ppb)
- Typical asthma features (nocturnal symptoms, documented glucocorticoid response)
- Smoking history ≥10 pack-years with post-bronchodilator FEV1/FVC < lower limit of normal 5
In this specific population, various biologics approved for severe asthma (including tezepelumab) have shown effectiveness in reducing exacerbations. 5 However, this represents off-label use for the COPD component.
Network Meta-Analysis Findings
Recent systematic review evidence confirms that among biologics studied in COPD:
Dupilumab is the only biologic with high-certainty evidence for reducing exacerbations (RR 0.68) in COPD patients with elevated eosinophils. 6
Tezepelumab may reduce exacerbations compared to placebo (RR 0.83), but this is low-certainty evidence. 6
In patients with blood eosinophils ≥300/mcL, tezepelumab probably improved FEV1 above the minimal clinically important difference (MD 0.15 L). 6
Clinical Bottom Line
For pure COPD without asthma features, stick to guideline-recommended therapies: bronchodilators, inhaled corticosteroids for appropriate patients, and pulmonary rehabilitation. 3 Tezepelumab remains investigational for COPD and should only be considered in research settings or in carefully selected patients with confirmed asthma-COPD overlap who meet criteria for severe asthma treatment. 5, 2