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Nucala (mepolizumab) is indicated as add-on maintenance treatment of adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) of an eosinophilic phenotype on a combination of an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA).1
*Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalisation (≥24 hours) or resulting in death. Nucala + SoC, 0.80/year (n=403) vs. placebo + SoC, 1.01/year (n=401) at Weeks 52-104; RR: 0.79 (95% CI: 0.66, 0.94; p=0.01), MATINEE primary endpoint. Mean rate of exacerbations in previous year in the Nucala population: 2.3.1,2
SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
Join Dr Neil Greening in exploring the MATINEE trial findings
COPD significantly impacts patients, healthcare systems, and society
Worldwide, COPD accounts for a greater disease burden and mortality rate than any other respiratory disease3
While many patients receive optimised inhaled therapy, up to:
4 in 10
continue to experience COPD exacerbations4
COPD is the second most common cause of NHS emergency admissions5
Second leading cause
of emergency hospitalisations5
Accounts for 1 in 8
acute adult medical admissions6
30,000
deaths annually6
MATINEE TRIAL: The longest phase 3 trial of any licensed COPD biologic, studied up to 2 years2
MATINEE Study Description1,2: 52- to 104-week multicentre, randomised, double-blind, pivotal trial evaluating Nucala 100 mg SC every 4 weeks vs. placebo, each added to SoC, in 804 patients ≥40 years of age with COPD with an EOS phenotype (defined as BEC ≥300 cells/µL at screening), a history of exacerbations (≥2 moderate or ≥1 severe) in past year, and moderate to very severe airflow limitation, and current/former smoking status. Patients with a past or present asthma diagnosis were excluded.
In both BOREAS and NOTUS, patients were randomized to receive dupilumab 300 mg every two weeks (Q2W) or placebo in addition to their background maintenance therapy for 52 weeks.7
SoC: standard of care was optimised ICS‑ based COPD maintenance triple therapy (ICS/LABA/LAMA).2
*Moderate and severe exacerbations: ‘Moderate’ defined as treated with systemic corticosteroids with/without antibiotics; ‘severe’ defined as requiring hospitalisation ≥24 hours.2
†Patients were required to have BEC ≥300 cells/μL at Screening Visit 0 to proceed to Visit 1, alongside a documented historical BEC ≥150 cells/μL in the 12 months prior to Screening Visit 0.8
‡Patients with no historical BEC ≥150 cells/μL were required to have BEC ≥150 cells/μL at Screening Visit 1.8
§Defined as use of an ICS-based triple inhaled therapy (fluticasone propionate ≥500 μg/day [or an equivalent dose of glucocorticoid], a LABA, and a LAMA) unless documentation of safety or intolerance issues related to LABA or LAMA.2,8
¶Due to the lower frequency of COPD exacerbations globally during the COVID-19 pandemic, the initial 52-week fixed-duration period was extended to a 104-week variable-duration period following regulatory approval. For patients enrolled in the study for 52 weeks, the exit visit was at Week 52. For patients receiving study treatment beyond 52 weeks, the exit visit was at Week 104 or aligned to the date the last randomised patient was scheduled to complete their Week 52 exit visit (whichever was sooner). In all cases, the exit visit was 4 weeks after the last dose.2,8
MATINEE enrolled COPD patients with moderate to very severe airflow obstruction, spanning GOLD stages 2 to 4*,2
*GOLD 2, GOLD 3 and GOLD 4: 42%, 45% and 13% of patients randomised to Nucala 100 mg SC, respectively.2
Reduce moderate and severe exacerbations* across a wide spectrum of eligible COPD patients vs SoC only1,2
21% significant reduction in overall moderate or severe exacerbations,* across patients with chronic bronchitis and/or emphysema vs SoC only1,2
The MATINEE primary endpoint was annualised rate of moderate or severe COPD exacerbations1
*Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalisation (≥24 hours) or resulting in death.1,2
MATINEE trial population: ≥40 years of age with COPD with an EOS phenotype (defined as BEC ≥300 cells/µL at screening), a history of exacerbations (≥2 moderate or ≥1 severe) in past year, and moderate to very severe airflow limitation, and current/ former smoking status. Patients with a past or present asthma diagnosis were excluded.1,2
Nucala + SoC, 0.80/year (n=403) vs. placebo + SoC, 1.01/year (n=401) at Weeks 52-104; RR: 0.79 (95% CI: 0.66, 0.94; p=0.01), MATINEE primary endpoint. Mean rate of exacerbations in previous year in the Nucala population: 2.3.1,2
SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
Reduction in moderate and severe COPD exacerbations, seen across patients with chronic bronchitis and emphysema vs SoC only*,9
Phenotypes are based on investigator assessment. Post-hoc analysis, statistical significance not calculated.
18% reduction in patients with chronic bronchitis + emphysema for Nucala + SoC, 0.88/year (n=81) vs. placebo + SoC, 1.07/year (n=62). RR: 0.82 (95% CI: 0.53, 1.26).9
*Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalisation (≥24 hours) or resulting in death. MATINEE post-hoc analysis of annualised rate of moderate/severe exacerbations as assessed by investigator. Patients who had neither chronic bronchitis nor emphysema were also evaluated (RR: 0.91; 95% CI: 0.54, 1.54). Post-hoc analysis.
†Nucala + SoC, 0.60/year (n=170) vs. placebo + SoC, 0.87/year (n=168) RR: 0.69 (95% CI: 0.51, 0.93).9
‡Nucala + SoC, 0.92/year (n=120) vs. placebo + SoC, 1.12/year (n=132). RR: 0.82 (95% CI: 0.61, 1.12).9
SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
Nucala + SoC extended the median time to first moderate or severe exacerbation* post initiation by 98 days compared with placebo + SoC only2
Secondary endpoints were tested hierarchically to control for multiplicity. The first endpoint was time to first moderate/severe exacerbation up to Week 104. The next endpoints (in order of hierarchy) did not meet statistical significance: Proportion of CAT score responders, SGRQ total score responders and E-RS:COPD responders at Week 52.1,2
*Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalisation (≥24 hours) or resulting in death.
Median time to first moderate/severe exacerbation was longer in the mepolizumab-treated group (419 days) versus the placebotreated group (321 days) by 98 days.2
The primary end point of annualized rate of moderate or severe exacerbations, was met. Estimated risk of a moderate/severe exacerbation by Week 104 was reduced by 28% in patients treated with Nucala: Nucala + SoC (n=403) 64.5, placebo + SoC (n=401) 68.3). HR 0.77 (95% CI: 0.64, 0.93), P=0.009. Annualised rate of exacerbations hospitalisation and/or ED visit was the secondary endpoint.1
SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
35% reduction in exacerbations requiring hospitalisations and/or ED visits vs SoC only (secondary endpoint - nominal significance)*,2
As an endpoint higher in the statistical hierarchy was not statistically significant, statistical inference cannot be made on these results.1,2
*Nucala + SoC, 0.13/year (n=403) vs. placebo + SoC, 0.20/year (n=401) at Weeks 52-104; RR: 0.65 (95% CI: 0.43, 0.96; p=0.032).2 Primary endpoint: Annualised rate of moderate/severe exacerbations up to Week 104 – was met. Secondary efficacy endpoints (in order of hierarchy):2
- Time to first moderate/severe exacerbation up to Week 104 – was met
- Proportion of CAT score responders, SGRQ total score responders, and E-RS:COPD responders at Week 52 – not met
- Annualised rate of exacerbations requiring ED visit and/or hospitalisation up to Week 104 – nominally significant SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
Nucala + SoC in COPD has been shown to have a tolerability and adverse event profile comparable to placebo + SoC in RCTs1,10
Across the three placebo-controlled studies in patients with COPD, the most commonly reported adverse reactions during treatment were headache (10%), back pain (7%) and arthralgia (5%)1
Adverse reactions ≥3% with Nucala were more common than placebo across RCTs10
| Adverse reaction, % | Nucala + SoC (n=1,043) | Placebo + SoC (n=1,046) |
|---|---|---|
| Back pain | 7 | 6 |
| Diarrhoea | 5 | 4 |
| Cough | 5 | 4 |
| Oropharyngeal pain | 4 | 2 |
| Urinary tract infection | 4 | 3 |
| Pain in extremity | 4 | 3 |
Adverse reactions ≥3% with Nucala were more common than across RCTs: Nucala + SoC (n=1,043) Placebo + SoC (n=1,046) respectively: Back pain 7%/6%; Diarrhoea 5%/4%; Cough 5%/4%; Oropharyngeal pain 4%/3%; Urinary tract infection 4%/3%; Pain in extremity 4%/3%.10
Herpes zoster: across the 3 COPD trials, 1% Nucala + SoC and 0.7% placebo + SoC.10
In the MATINEE 52-week Phase III clinical study, some of the most frequent on-treatment adverse events for Nucala + SoC (n=403) and Placebo + SoC (n=401) were: On-treatment adverse events: Nucala + SoC = 299 (74%); Placebo + SoC = 307 (77%)1 ; Any serious adverse event of death: Nucala + SoC = 99 (25%); Placebo + SoC = 112 (28%)1 ; On-treatment adverse events leading to withdrawal: Nucala + SoC = 15 (4%); Placebo + SoC = 16 (4%).1
SoC: standard of care was optimised ICS‑based COPD maintenance triple therapy (ICS/LABA/LAMA).2
Mepolizumab must not be used to treat acute COPD exacerbations.1
Give your eligible COPD patients 50% fewer doses per year with Nucala compared to Dupixent1,7
Over one year, a patient on Nucala receives 13 injections, compared to 26 injections with Dupixent.1,7
No comparative efficacy or safety conclusions can be drawn from this information.
The recommended dose of Nucala is 100 mg administered subcutaneously once every 4 weeks.1
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Abbreviations
BEC, blood eosinophil count; CAT, COPD Assessment Test; CI, confidence interval; COPD, chronic obstructive pulmonary disease; E-RS, EXACT-Respiratory Symptoms; ED, emergency department; EOS, eosinophilic; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; ITT, intention to treat; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist; mMRC, Modified Medical Research Council; NHS, National Health Service; Q4W, every 4 weeks; RCT, randomised controlled trial; RR, risk ratio; SC, subcutaneous; SoC, standard of care; V, visit.
Indication
Nucala is indicated as add-on maintenance treatment of adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) of an eosinophilic phenotype on a combination of an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA).¹
References
- Nucala (mepolizumab) Summary of Product Characteristics.
- Sciurba FC, et al. N Engl J Med. 2025;392(17):1710–1720.
- GBD 2019 Chronic Respiratory Diseases Collaborators. E clinical Medicine. 2023;59:101936.
- Mullerova H, et al. Am J Respir Crit Care Med. 2017;195:A4986.
- NICE. COPD: How common is it? Last revised October 2025. Available at: https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/background-information/prevalence-incidence/. [Accessed March 2026].
- Thomas S, et al. COPD Voices. A matter of life and breath. 2025. Available from: https://www.kcl.ac.uk/sims/assets/copd-voices-final-29042025.pdf. [Accessed March 2026].
- Dupixent (dupilumab) Summary of Product Characteristics.
- Sciurba FC, et al. N Engl J Med. 2025;392(17):1710–1720. Supplementary materials.
- Pavord I, et al. Am J Respir Crit Care Med. 2025;211:A5033.
- GSK Data on File: REF-312973.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GSK on 0800 221 441 or UKSafety@gsk.com.
June 2026 | PM-GB-MPL-WCNT-250014 (V1.0)
