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Biologics in COPD

Who may benefit, what the evidence shows and how treatment is arranged

Biologic medicines offer an additional option for a selected group of people with chronic obstructive pulmonary disease (COPD). They target inflammatory pathways that can contribute to repeated flare-ups, also called exacerbations. They do not repair established emphysema, replace inhalers or treat an acute emergency.

We can review your diagnosis, treatment and flare-up history and advise whether specialist biologic assessment is appropriate. Most patients requiring biologics transfer to an NHS specialist service for eligibility assessment, treatment and monitoring.

General COPD guide | Arrange an assessment

 

1. Why inflammation matters

COPD is not the same in every patient. Some people have an inflammatory pattern involving eosinophils, a type of white blood cell. A raised blood eosinophil count can help identify people more likely to benefit from particular anti-inflammatory treatments. It is interpreted with the clinical history, rather than used as a diagnosis on its own.

Asthma and COPD can coexist, but evidence for a medicine in asthma cannot automatically be applied to COPD. Breathlessness may also reflect heart disease, anaemia, reduced fitness, obesity, infection or other lung conditions. A biologic is unlikely to address all of these causes.

 

2. Assessment before considering a biologic

The starting point is confirmation of COPD, usually including post-bronchodilator spirometry, and a review of symptoms and previous exacerbations. We check inhaler technique and regular use, smoking and other exposures, vaccination, pulmonary rehabilitation and any conditions contributing to deterioration. Sputum testing or CT may be needed where recurrent infection or bronchiectasis is suspected.

Usual treatment remains essential. Triple inhaled therapy combines an inhaled corticosteroid with two long-acting bronchodilators: a LABA and a LAMA. Some people cannot use inhaled steroids and need a different plan. Selected patients may benefit from other measures, including airway clearance, preventive antibiotics, roflumilast, oxygen assessment or lung-volume-reduction assessment.

Bring dates of steroid or antibiotic courses, emergency visits and admissions, together with your inhaler list and previous blood counts. Eosinophils can vary and may be lowered by steroid treatment, so the team considers the timing and pattern of results.

NICE: COPD care | Asthma + Lung UK: biologic assessment

 

3. Current treatment options and NHS access

Dupilumab blocks the shared IL-4/IL-13 receptor pathway. It is given as an injection under the skin, usually every two weeks. NICE TA1142, published in March 2026, supports add-on treatment for eligible adults with uncontrolled COPD and raised blood eosinophils.

For dupilumab, NICE defines raised eosinophils as at least 300 cells per microlitre (0.3 × 10⁹/L), and uncontrolled disease as at least two moderate exacerbations or one severe exacerbation in the previous year. Appropriate background inhaled therapy is required, usually triple therapy, or LABA/LAMA where inhaled steroids are unsuitable. The specialist applies the full guidance and reviews response.

Mepolizumab targets IL-5 and is usually injected every four weeks. NICE TA1166, published in June 2026, provides recommendations for add-on maintenance treatment of uncontrolled COPD with raised blood eosinophils in adults. The service checks the current criteria and prescribing arrangements for your circumstances.

NICE: dupilumab eligibility and review | NICE: mepolizumab

Most patients who need these medicines transfer from private assessment to NHS specialist care. We can share our findings with your GP and the relevant service. Referral does not guarantee eligibility, and the NHS team confirms the treatment and follow-up plan.

 

4. Dupilumab: BOREAS and NOTUS

BOREAS (2023) was a randomised, placebo-controlled trial in 939 people with COPD, raised eosinophils and exacerbations despite background inhaled treatment. Annualised moderate or severe exacerbation rates were 0.78 with dupilumab versus 1.10 with placebo, approximately a 30% relative reduction. Lung function and some patient-reported outcomes also improved.

NOTUS (2024) provided an independent confirmatory trial in 935 people. Annualised exacerbation rates were 0.86 versus 1.30, a 34% relative reduction. Lung function improved, although not every symptom or quality-of-life measure showed a significant difference.

The trials focused on a selected population with blood eosinophils of at least 300 cells per microlitre, recurrent exacerbations and chronic productive cough. A history of asthma was generally excluded. These findings should not be extended to all people with COPD or used to promise an individual response.

BOREAS: original publication | NOTUS: original publication

A pooled analysis of both trials supported the reduction in moderate or severe exacerbations. However, fewer flare-ups should not be interpreted as proof of a survival benefit or reversal of lung damage.

Pooled BOREAS/NOTUS analysis

 

5. Mepolizumab: METREX, METREO and MATINEE

METREX and METREO (2017) studied patients with repeated exacerbations despite triple inhaled therapy. METREX found an 18% relative reduction in moderate or severe exacerbations in the eosinophilic subgroup, but no significant benefit in the unselected overall population. METREO did not meet its significance thresholds after adjustment for multiple comparisons. These early mixed results showed why patient selection matters.

MATINEE (2025) studied 804 people with an eosinophilic COPD pattern, a blood eosinophil count of at least 300 cells per microlitre and previous exacerbations while receiving triple therapy. Annualised moderate or severe exacerbations were 0.80 with mepolizumab versus 1.01 with placebo: a 21% relative reduction. Time to the first exacerbation was longer.

MATINEE did not show significant between-group differences in its quality-of-life and symptom measures. The main established benefit was prevention of flare-ups, rather than a guaranteed improvement in daily breathlessness.

METREX and METREO | MATINEE

 

6. Benralizumab: negative maintenance trials and ABRA

GALATHEA and TERRANOVA (2019) did not demonstrate a statistically significant reduction in the primary COPD exacerbation outcome. Exploratory subgroup findings generated hypotheses, but were not sufficient to establish routine treatment.

The later RESOLUTE study also did not reach statistical significance for its primary endpoint, according to the sponsor's September 2025 report. These findings illustrate that success in severe eosinophilic asthma does not necessarily translate into success in COPD maintenance treatment.

GALATHEA and TERRANOVA publication | RESOLUTE: sponsor report

ABRA (published online 2024) asked a different question: treatment at the time of an eosinophilic asthma or COPD exacerbation. In this relatively small phase 2 trial, benralizumab-based treatment reduced treatment failure compared with prednisolone alone. This promising acute-treatment research does not establish routine COPD maintenance prescribing and does not replace an existing rescue plan.

ABRA publication

 

7. Tezepelumab and emerging pathways

COURSE (2025) tested tezepelumab in 333 people with COPD despite triple therapy. It did not meet its main exacerbation-reduction endpoint in the overall population. Signals in higher-eosinophil subgroups need confirmation and should not be treated as established efficacy.

COURSE publication

Other studies target IL-33 or its receptor. Sponsor-reported results were mixed for itepekimab (AERIFY-1 positive; AERIFY-2 negative) and astegolimab (ALIENTO positive; ARNASA negative). Positive phase 3 results have been reported for tozorakimab in OBERON, TITANIA and MIRANDA. These research programmes are distinct from the established NICE-supported options described above.

Regulatory authorisation, NHS recommendations and clinical availability must be checked separately from a positive trial announcement. Emerging findings may change practice after full appraisal; they are not a promise of access through this clinic.

AERIFY: sponsor results | ALIENTO/ARNASA: sponsor results | Tozorakimab: sponsor trial update

 

8. What the percentages mean

A 30% relative reduction means approximately three fewer events for every ten that would otherwise occur in a comparable trial population. It does not mean a 30% chance of cure. For example, the BOREAS rates differ by about 0.32 exacerbations per patient-year on average; an individual's experience may differ considerably.

There is no direct randomised comparison in the pivotal trials above showing which of dupilumab or mepolizumab is best for an individual patient. Comparing their headline percentages is unreliable because the study populations and designs differed. Decisions consider eligibility, the pattern of illness, associated conditions, treatment burden and response.

 

9. Side effects and monitoring

The specialist explains the medicine's patient information leaflet, injection training and how to report problems. Injection-site reactions and drug-specific side effects can occur. Rare serious allergic reactions need emergency treatment. Discuss other medicines, pregnancy plans and relevant infection history before starting treatment.

Keep using prescribed inhalers and other COPD measures. The team records exacerbations, admissions, symptoms and side effects and reviews whether continuing treatment is worthwhile. An acute flare-up still needs assessment and treatment according to your action plan; a biologic injection is not a rescue medicine.

Call 999 for severe breathing difficulty, collapse, blue or grey lips, or swelling of the tongue or throat. For worsening symptoms without these emergency features, follow your agreed COPD plan and seek prompt clinical advice.

Asthma + Lung UK: practical treatment information

 

10. Questions to ask your specialist

Is my diagnosis confirmed? Have my inhalers and other treatments been optimised? What do my eosinophil results mean? Do I meet the current NHS criteria? What benefit are we aiming for? When will response be reviewed? Who will prescribe and monitor treatment, and whom should I contact during a flare-up?

Evidence and access information checked September 2026. This is general adult patient information; the treatment decision is individual and uses current guidance.

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© 2019. The Chest Clinic.

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