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Nucala improves CRSwNP symptoms and delivers asthma control* in patients with SEA and comorbid CRSwNP1,2

*measured by change from baseline in ACQ-5 score

Post-hoc analysis of modified intention-to-treat (mITT) population (aged 12 +) in MUSCA.1 MUSCA primary endpoint, change in SGRQ total score from baseline at week 24, was met.3 LS mean change (SE) from baseline in SNOT-22 score of NP patients at week 24 (n=78) Nucala: -13.7 (2.6) n=44, (greater than MCID of -8.9 points); (n=34) placebo: -1.9 (3.0). Treatment difference of −11.8 (95% CI, −19.8 to −3.9).1,5

REALITI-A post hoc analysis at 2-years.2 REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4 ACQ-5 LS mean score at 24 months with CRSwNP at enrollment, Nucala: 0.98 (n=84) vs. Baseline: 2.72 (n=307). Statistical significance not calculated.2

The image above is a fictional patient for illustrative purposes.

Nucala (mepolizumab) Indication

Nucala (mepolizumab) is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. Nucala is also indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.6

Nucala is not reimbursed for CRSwNP in the UK

See Nucala Safety Information

Several endoscopic nasal polyp (NP) scoring systems are based on the visualisation of the extent and volume of NP in the nasal cavity and mostly use the lower borders of middle and inferior turbinates as the main reference lines7 while visual Analogue Scale (VAS) is a psychometric instrument used to subjectively quantify patients' symptom severity.8

Synapse was a 52 week randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial.9

NA

The co-primary endpoints of Synapse were:

Infographic depicting outcomes of co-primary endpoints from the Synapse study of Nucala (mepolizumab)

SYNAPSE: Median change from baseline to week 52, Nucala + SoC: -1.0 (n=206); placebo + SoC: 0.0 (n=201). Treatment effect: -0.73 (95% CI –1.11 to -0.34); p<0.0001.9

SYNAPSE: Median change in nasal obstruction VAS score from baseline to weeks 49-52, Nucala + SoC: -4.41 (n=206); placebo + SoC: -0.82 (n=201). Treatment effect –3·14 (95% CL –4·09 to –2·18); p<0.0001.9

SYNAPSE Secondary Endpoints9:

  • Time to first nasal polyp surgery until week 52*
  • Proportion of patients requiring systemic corticosteroids for nasal polyps until week 52

Change from baseline in:

  • Mean overall VAS symptom score during weeks 49-52
  • SNOT-22 total score at week 52
  • Mean composite VAS score (combining scores for nasal obstruction, nasal discharge, throat mucus, and loss of smell) during weeks 49-52
  • Mean VAS score for loss of smell during weeks 49-52

*defined as invasive procedure requiring instruments resulting in incision and removal of tissue (polypectomy).

SYNAPSE: Time to first nasal polyp surgery was also longer for patients treated with Nucala versus placebo9

Graph depicting data on the probablity of and time to first nasal polyp surgery in the Synapse study of Nucala (mepolizumab)

Reproduced from: Han JK, et al. Lancet Respir Med. 2021;9(10):1141-1153.

Nucala is not reimbursed for CRSwNP in the UK.

REALITI-A was a 2-year real world, global, prospective, observational, single-arm study in adults aged 18 years and over11.

NA

REALITI-A Primary Outcome: Rate of clinically significant exacerbations* 12-months post-exposure†4.

REALITI-A Secondary Outcomes4:

  • Rate of clinically significant exacerbations* 24-months post-exposure.†
  • Exacerbations requiring hospitalisation and/or ED visit
  • Exacerbations requiring hospitalisation
  • Reduction in daily OCS dose from pre-treatment to 24-months post-exposure
  • Proportion of patients who discontinued mOCS
  • Change from baseline in BEC
  • Safety: AEs and SAEs

*Clinically significant exacerbations: a deterioration in asthma requiring SCS (any dose; oral steroids for ≥3 days or a single systemic administration of corticosteroids) and/or hospitalisation and/or emergency department visit4.

†Compared with 12 months prior to mepolizumab exposure4.

REALITI-A shows the greatest improvement in rate of CSEs was in patients with SEA and co-morbid NP.10

Post-hoc interim analysis of REALITI-A at 1-year. REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4 Reduction in mean events/year from pre-treatment to follow-up, with NP: 4.16 to 1.02 (n=321) vs without NP: 4.35 to 1.36 (n=501)10 NP status was self-reported by patients at enrolment.10
Mepolizumab should not be used to treat acute asthma exacerbations.

Clinically Significant Exacerbations - a deterioration in asthma requiring SCS (any dose; oral steroids for ≥3 days or a single systemic administration of corticosteroids) and/or hospitalisation and/or emergency department visit.4

Nucala reduced CSEs by 75% in SEA patients with co-morbid NP vs 69% in patients without NP10

Post-hoc interim analysis of adult SEA patients in REALITI-A10. REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4
Reduction in mean events/year from pre-treatment to 12-months with NP: 4.16 to 1.02 (n=321); without NP: 4.35 to 1.36 (n=501). NP status was self-reported by patients at enrolment10.

Mepolizumab should not be used to treat acute asthma exacerbations.
Clinically Significant Exacerbations – a deterioration in asthma requiring SCS (any dose; oral steroids for ≥3 days or a single systemic administration of corticosteroids) and/or hospitalisation and/or emergency department visit.4

Infographic depicting annual mean exacerbation outcomes of SEA patients with CRSwNP in the REALITI-A study of Nucala (mepolizumab)

3.48x MCID achieved by CRSwNP patients in ACQ-5 score at 2 years vs. baseline

REALITI-A post hoc analysis at 2-years. REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4 ACQ-5 score Nucala: 0.98 (n=84) vs. Baseline: 2.72 (n=307)2.
MCID was a change of 0.5 points.11

ACQ is a multidimensional self-administered construct assessing asthma control.11

SYNAPSE: Greater improvement in SNOT-22 scores from baseline with Nucala than placebo9.

Graph depicting data on the median change from baseline in SNOT-22 total score in the Synapse study of Nucala (mepolizumab)

SYNAPSE: Median change from baseline in SNOT-22 total score at week 52 Nucala: -30.0 (n=206); placebo: -14.0 (n=201). Treatment effect: -16.49 (-23.57 to -9.42) (95% CI) p=0.00329

Graphic depicting ‘63%’ in a circle

of patients with SEA and co-morbid CRSwNP on Nucala discontinued maintenance OCS 2-years post treatment initiation2,4

Post-hoc analysis of REALITI-A at 2 years. REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4

n=135 patients had CRSwNP at enrollment, at week 101-104, 63% n = 48/76 were able to discontinue maintenance OCS (mOCS). Statistical significance not calculated.2

Abrupt discontinuation of corticosteroids after initiation of mepolizumab therapy is not recommended.

See Nucala Safety Information

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Abbreviations

ACQ, Asthma Control Questionnaire; AEs, adverse events; BEC, blood eosinophil count; BL, baseline; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; CSEs, Clinically significant exacerbations; ED, emergency department; mOCS, maintenance oral corticosteroids; NP, nasal polyps; OCS, oral corticosteroids; SAEs, serious adverse events; SCS, systemic corticosteroids; SE, standard error; SEA, severe eosinophilic asthma; SGRQ, St George’s Respiratory Questionnaire; SoC, standard of care; SNOT-22, Sino-Nasal Outcome Test 22.

References

  1. Howarth P, et al. J Allergy Clin Immunol. 2020;145:1713-15.
  2. Lee et al. AAAAI 2023; poster 48
  3. Chupp GL; Lancet Respir Med. 2017; 5;390-400
  4. Harrison T, et al. Eur Respir J. 2020;56:2000151
  5. GSK Data on File REF-215426
  6. Nucala Summary of Product Characteristics.
  7. Gevaert P et al. Allergy. 2023. 78(4): 912-922
  8. Doulaptsi M et al. Clin Transl Allergy. 2018;8;1-6
  9. Han J et a. Lancet Respir Med. 2021. 9(10):1141-1153
  10. Liu MC et al. Presented at ATS 2022. Abstract A4837
  11. Jia C, et al.The Journal of allergy and clinical immunology.2013;131;695-703

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.

May 2025 I PM-GB-MPL-WCNT-240018 (V1.0)