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NP-AU-NA-WCNT-190017

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Choose indication Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

NUCALA patient with chronic rhinosinusitis with nasal polyps standing with dog grooming shop in background

NUCALA is the first and only anti-IL-5 with proven efficacy in adult patients with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP)*1-3

*change from baseline in NPS and nasal obstruction VAS score vs. placebo at week 52.2

SYNAPSE#: The only trial that examined the efficacy and safety of a biologic exclusively in CRSwNP patients with ≥1 previous surgery*2

*Nasal surgery defined as any incision of the paranasal sinuses and removal of polyp tissue from the nasal cavity (polypectomy) and the sinuses in the past 10 years.2

In the SYNAPSE2 trial, it was demonstrated that in patients with severe CRSwNP, NUCALA can:

reduce nasal polyp size

Reduce nasal
obstruct†

Reduce nasal obstruction

Reduce nasal
polyp size*

reduce repeat surgery

Reduce repeat
surgery‡

significantly reduce the need for OCS

Significantly reduce the
need for OCS.$

improve quality of life

Improve quality
of life§
 

  • SYNAPSE Study Design

    Adapted from Han JK et al. 2021 (supplementary appendix).4

    DESCRIPTION2
    A 52 week, randomised, double blind, parallel group Phase III study to assess the clinical efficacy and safety of NUCALA 100 mg subcutaneously as an add on to maintenance treatment in adults with severe bilateral nasal polyps compared to placebo.

    ENDPOINTS2
    CO-PRIMARY ENDPOINTS:
    Change from baseline in total endoscopic nasal polyp score at Week 52, Change in baseline in mean nasal obstruction visual analogue sale score during Weeks 49-52.

    STUDY POPULATION, n=4072
    Adults (18 years old) with a history of 1 prior surgery for nasal polyps, and recurrent nasal polyps despite treatment with existing standard of care, and needing additional surgery.

    TREATMENT2
    Patients were randomised to receive either NUCALA 100 mg subcutaneously or placebo once every 4 weeks, in addition to standard of care (daily mometasone furoate nasal spray, and saline nasal irrigations and short courses of SCS and/or antibiotics, as required)

†Statistically significant reduction in nasal obstruction Visual Analogue Score (VAS score). Median change from baseline, range 0–10: NUCALA (n=206) -4.41, baseline score 9.0; placebo (n=201) -0.82, baseline score 9.1; p<0.0001.2
*Statistically significant reduction in nasal polyp score vs placebo at 52 weeks. Median change from baseline, range 0–8: NUCALA (n=206) -1.0, baseline score 5.0; placebo (n=201) 0.0, baseline score 6.0; p<0.0001.2
‡Secondary endpoint, reduction in need for surgery. Time to nasal surgery up to week 52 (n=407). Nucala 9% vs. placebo 23%: HR 0.43 (95% CI 0.25, 0.76; p=0.0032).2,4
$Secondary endpoint, patients requiring ≥1 course of oral corticosteroids (OCS) up to week 52 (n=407). NUCALA 25% vs. placebo 37% (42% reduction): OR 0.58 (95% CI 0.36, 0.92; p=0.020).2
§Secondary endpoint, Improvement in quality of life as measured by change in SNOT-22 score from baseline. Median change at week 52 (n=407), range 0-110: NUCALA -30.00 vs. placebo -14.00; adjusted difference in medians -16.49 (95% CI -23.57, -9.42; p=0.0032).2

Why might your patients be coming back with recurrent nasal polyps after surgery?

Eosinophilic nasal polyps are associated with elevated IL-5 Levels5

Patients with nasal polyp recurrence after surgery had higher nasal section IL-5 levels compared with patients without recurrence.6,7
IL-5 is the key cytokine involved in the differentiation, migration, activation and survival of eosinophils.8

Circle graphic stating up to 90% of cases of nasal polyps are driven by eosinophilic inflammation

of nasal polyps are driven by eosinophilic inflammation9

Circle graphic stating up to 40% of patients experience recurring nasal polyps within 1.5 years of surgery

experience recurring nasal polyps within 1.5 years of surgery*12
*Prospective, multicentre, observational cohort investigation into treatment outcomes following endoscopic sinus surgery (n=129)

Meet Oscar*, currently suffering from severe CRSwNP

circular headshot of patient with chronic rhinosinusitis with nasal polyps looking at the camera

“I'm worried I'm going to need another nasal polyp surgery”

*Fictional patient profile based on patient insights;2,13,14 for illustrative purposes only

red icon of nose side profile and droplet

Complaints:
Constant runny nose
Discomfort due to mucus in throat
Concerned about the likelihood of additional surgeries
Facial Pain
Difficulty breathing due to nasal obstruction
Fatigue due to difficulty sleeping

red icon of clipboard

Medical history:
Age: 49
Duration of CRSwNP: 9 years
Number of previous surgeries: 1
Time since previous nasal polyp surgery: 3 years
Endoscopic nasal polyp score (scale 0-8): 6
Nasal obstruction VAS score (scale 0-10): 8.9
Blood eosinophil count: 390 cells/µL

red icon of circular tablet

Current medication:
400mg mometasone furoate nasal spray daily
One OCS burst in the past 12 months

How can NUCALA help Oscar?

In the SYNAPSE study (a randomised, double-blind, placebo-controlled, parallel-group phase III trial), add-on treatment with NUCALA demonstrated:

Nasal Polys

Statistically significant reduction in nasal polyp score vs. placebo at week 52.*2

*Median change from baseline, range 0–8: NUCALA (n=206) -1.0, baseline score 5.0; placebo (n=201) 0.0, baseline score 6.0; p<0.001.2 (co-primary endpoint)

red circle graphic with 5x in the centre

Over 5x reduction in nasal obstruction VAS score vs. placebo during weeks 49–52.*2

*Median change from baseline, range 0–10: NUCALA (n=206) -4.41, baseline score 9.0; placebo (n=201) -0.82, baseline score 9.1; p<0.0001.2 (co-primary endpoint)

60% of patients had improvement of >3 points in nasal obstruction VAS score during weeks 49–52.*2

*>3 points improvement in nasal obstruction VAS score: NUCALA (n=206) 124 (60.2%) vs. placebo (n=201) 73 (36.3%); p values not reported.2

red circle graphic with 73% of patients in the middle

73% of patients experienced clinically meaningful improvement in HRQoL* vs. 54% with placebo.†2

†Exploratory endpoint, week 52 (n=407): OR 2.44 (95% CI 1.60, 3.73; p<0.0001).2
*Proportion of patients who achieved ≥8.9 improvement (MCID) from baseline in SNOT22 score in the absence of surgery.2

30 points improvement in SNOT-22 total score from baseline.*2

Secondary endpoint, median change at week 52 (n=407), range 0-110: NUCALA -30.00 vs. placebo -14.00; adjusted difference in medians -16.49 (95% CI -23.57, -9.42; p=0.0032).2

red circle graphic with 57% in the middle

57% reduction in need for surgery vs. placebo.*2

*Secondary endpoint, time to nasal surgery† up to week 52 (n=407). NUCALA 9% vs. placebo 23%: HR 0.43 (95% CI 0.25, 0.76; p=0.0032).4

In patients with baseline blood eosinophil count ≥300 cells/µL: 69% reduction in need for surgery vs. placebo*15

*Post hoc subgroup analysis, time to nasal surgery† up to week 52 (n=278): HR 0.31 (95% CI 0.15, 0.64; p value not reported).15
†Nasal surgery included any procedure involving instruments resulting in removal of tissue from the nasal cavity.2

NUCALA has robust safety and tolerability data across multiple indications.*1

NUCALA was generally well tolerated in patients with CRSwNP.2

*SEA, CRSwNP, EGPA.1

Safety Endpoints, n (%)
Adverse event
 NUCALA (n=206) %
 Placebo (n=201) %
Any 82 84
Nasopharyngitis 25 23
Oropharyngeal pain 8 5
Arthralgia 6 2
Abdominal pain upper 3 2
Pyrexia 3 2
Diarrhoea 3 2
Rash 3 <1
Nasal Dryness 3 <1

What might be driving your patients’ recurrent nasal polyps?

Eosinophils are the most common inflammatory cells in the pathogenesis of nasal polyps.11,16
Their growth, differentiation and recruitment is primarily driven by
IL-5.8

Graph of nasal polyp recurrence following surgery in patients with elevated vs fewer tissue eosinophils

Adapted from Tosun et al. 2010

†Eosinophil counting in nasal polyps was carried out retrospectively on histologic slides by computer-assisted image analysis software.10

How does NUCALA work?

NUCALA targets interleukin-5 (IL-5), the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.8

infographic of eosinophil describing Nucala's mechanism of action

Blood eosinophil count over 52 weeks vs placebo from SYNAPSE study

graph of blood eosinophil count over 52 weeks on Nucala vs. placebo

Adapted from Han JK et al. 2021 (supplementary appendix).4

SYNAPSE study design

Proven results across multiple indications.1

NUCALA is indicated as:

  • Add-on treatment for Severe Eosinophilic Asthma (SEA) in patients aged 12 years and over.1
  • Add-on treatment in adult patients (18 years and above) with severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with an inadequate response to intranasal corticosteroids.1
  • Add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA ) in adult patients aged 18 years and over.1

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Abbreviations

CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; EGPA, Eosinophilic granulomatosis with polyangiitis; HRQoL, health-related quality of life; IL, interleukin; LEAD, Lung, heart, social, body; LS, least squares; MCID, minimal clinically important difference; NPS, nasal polyp score; OCS, oral corticosteroid; OR, odds ratio; SC, subcutaneous; SEA, severe eosinophilic asthma; SoC, standard of care; SNOT, Sino-Nasal Outcome Test; VAS, visual analogue scale.

References

  1. Nucala Product Information.
  2. Han JK et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebocontrolled, phase 3 trial. Lancet Respir Med 2021;9(10):1141-53.
  3. Severe Asthma Toolkit. Monoclonal antibodies [updated 2022 Oct 27; accessed 2023 Mar 3]. Available from: https://toolkit.severeasthma.org.au/medications/monoclonal-antibodies/
  4. Han JK et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebocontrolled, phase 3 trial. Lancet Respir Med 2021;9(10):1141-53 (Supplementary appendix).
  5. Van Bruaene N et al. T -cell regulation in chronic para nasal sinus disease. J Allergy Clin lmmunol 2008 Jun;121(6):1435-41.
  6. Mortuaire G et al. T helper 2 inflammatory markers are associated with recurrence in chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery. Rhinology 2020;58(5):444-50.
  7. Sun DI et al. Clinical significance of eosinophilic cationic protein levels in nasal secretions of patients with nasal polyposis. Eur Arch Otorhinolaryngol 2009;266(7):981-6.
  8. Gevaert P et al. The roles of eosinophils and interleukin-5 in the pathophysiology of chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol 2022;doi: 10.1002/alr.22994.
  9. Fujieda S et al. Eosinophilic chronic rhinosinusitis. Allergol Int 2019;68(4): 403-12.
  10. Tosun F et al. Relationship between postoperative recurrence rate and eosinophil density of nasal polyps. Ann Otol Rhinol Laryngol 2010;119(7):455-9.
  11. Lou H et al. Cellular phenotyping of chronic rhinosinusitis with nasal polyps. Rhinology 2016;54(2):150-9.
  12. DeConde AS et al. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope 2017;127(3):550-5.
  13. Vennik J et al. Chronic rhinosinusitis: a qualitative study of patient views and experiences of current management in primary and secondary care. BMJ Open 2019;9(4):e022644
  14. Hall R et al. Understanding the patient experience of severe, recurrent bilateral nasal polyps: a qualitative interview study in the United States and Germany. Value Health 2020;23(5):632-41.
  15. Bachert C et al. Mepolizumab for chronic rhinosinusitis with nasal polyps: treatment efficacy by comorbidity and blood eosinophil count. J Allergy Clin lmmunol 2022;149(5):1711-21.e6.
  16. Lou H et al. Highlights of eosinophilic chronic rhinosinusitis with nasal polyps in definition, prognosis and advancement. Int Forum Allergy Rhinol 2018;8(11):1218-25.

PBS Information: The 100 mg vial and 100 mg/mL pen are listed on the PBS as a section 100 item for uncontrolled severe asthma. Refer to the PBS schedule for full authority information. The 100 mg/mL pen is listed on the PBS as a section 100 item for CRSwNP. Refer to the PBS schedule for full authority information. NUCALA is not listed on the PBS for EGPA.

Please review Product Information before prescribing. Product Information can be accessed at www.gsk.com.au/nucala

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PM-AU-MPL-WCNT-230005
Date of approval: June 2024