BATTLE TESTED
IN EOS DISEASE

NUCALA reduced nasal polyp symptoms^* and protected against surgery in patients with CRSwNP

NUCALA reduced nasal polyp
symptoms^* and protected against
surgery in patients with CRSwNP

NUCALA is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Choose NUCALA for CRSwNP

Reduced
nasal polyp size^†

Reduced
nasal obstruction^†

Reduced repeat surgery^‡

View efficacy results

Symptoms include nasal obstruction, nasal discharge, mucus in the throat, loss of smell.

Also choose NUCALA for improvement in quality of life,^§ based on SNOT-22

In the SYNAPSE study, all primary and secondary endpoints were met with statistical significance.¹

^†Co-primary endpoints:

Significant improvement in nasal polyp size. LS mean^|| change from baseline in total endoscopic nasal polyp score at Week 52: NUCALA + SOC^¶ (n=206), –0.87 (baseline score: 5.4) vs placebo + SOC^¶ (n=201), 0.06 (baseline score: 5.6); P<0.001.^1,2

Significant improvement in nasal obstruction. LS mean^|| change from baseline in nasal obstruction VAS score at Weeks 49-52: NUCALA + SOC^¶ (n=206), –4.40 (baseline score: 8.9) vs placebo + SOC^¶ (n=201), –2.54 (baseline score: 9.0); P<0.001.^1,2

See more data

Key secondary endpoint: Time to next nasal polyp surgery up to Week 52: 57% reduction in the proportion of patients who had surgery with NUCALA + SOC vs placebo + SOC, HR: 0.43; P=0.0032.¹

View surgery results

Secondary endpoint: Median change from baseline in SNOT-22 total score at Week 52; NUCALA + SOC, 30-point improvement vs placebo + SOC, 14-point improvement; P=0.0032.¹

Review the data

View full study design

LS means from analysis using mixed model repeated measures.

Defined as daily mometasone furoate nasal spray in addition to saline nasal irrigations and courses of systemic corticosteroids and/or antibiotics as required.

HR=hazard ratio; IL=interleukin; LS=least squares; SNOT-22=sino-nasal outcome test (22-item); SOC=standard of care; VAS=visual analogue scale.

Hear from a peer

An expert in otolaryngology describes how NUCALA can help patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Transcript
ONSCREEN TEXT:
NUCALA (mepolizumab) for Chronic Rhinosinusitis With Nasal Polyps

DR. FRANZESE:
Hello, I am Dr. Christine Franzese from the Department of Otolaryngology - Head and Neck Surgery at the University of Missouri in Columbia. In this chapter, I will discuss the use of NUCALA (mepolizumab) for chronic rhinosinusitis with nasal polyps.

Before I begin, please listen as the narrator reviews the Indications and Important Safety Information for NUCALA.

ONSCREEN TEXT:
INDICATIONS AND IMPORTANT SAFETY INFORMATION

SEA
add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

CRSwNP
add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

EGPA
treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

HES
treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to mepolizumab or excipients.

Additional Important Safety Information will be presented later in this video.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com.

NUCALA injection is available as a 100-mg/mL vial, autoinjector, and prefilled syringe.

NARRATOR:
NUCALA is indicated for the:

add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable nonhematologic secondary cause.

Contraindications: Known hypersensitivity to mepolizumab or excipients.

ONSCREEN TEXT:
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS.
Hypersensitivity Reactions:
Hypersensitivity reactions (for example, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (that is, days). Discontinue if a hypersensitivity reaction occurs.

Acute Asthma Symptoms or Deteriorating Disease: NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster: Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

Please see Important Safety Information for NUCALA throughout this video.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com.

NARRATOR:
WARNINGS AND PRECAUTIONS. Hypersensitivity Reactions:
Hypersensitivity reactions (for example, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (that is, days). Discontinue if a hypersensitivity reaction occurs.

Acute Asthma Symptoms or Deteriorating Disease NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster: Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

ONSCREEN TEXT:
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Reduction of Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

Additional Important Safety Information for NUCALA will be presented later in this video.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com.

NARRATOR:
Reduction of Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

Additional Important Safety Information will be presented later in this video.

DR. FRANZESE:
In this chapter, I will discuss only the chronic rhinosinusitis with nasal polyposis indication.

ONSCREEN TEXT:
Eosinophilic Inflammation Can Drive Nasal Polyp Recurrence^1-3

[bar chart showing percent of postoperative nasal polyp recurrence during 30-month follow-up for patients with higher and lower-tissue eosinophil density.^* The 22 patients with higher eosinophil density* had 82% recurrence. The 20 patients with lower eosinophil density had 25% recurrence.]

After surgery, nasal polyp recurrence was 3X greater in patients with elevated eosinophils^1*

Up to 90% of recurrent nasal polyps have predominantly eosinophilic inflamation^1,3-5†

^*Based on a retrospective single-center study to investigate the relationship between eosinophil density in nasal polyp tissue and recurrence in adults who underwent endoscopic sinus surgery for massive nasal polyposis (filled at least half of each nostril). Patients were categorized as higher density (>4 eosinophils/1000 μm²) or lower density (≤3 eosinophils/1000 μm²) by examining digital images taken at x400 magnification.¹
^†Based on studies that examined the presence of eosinophil leukocyte infiltration in nasal polyp biopsy tissue of patients in the US and Europe.

DR. FRANZESE:
Eosinophilic inflammation can drive nasal polyp recurrence. Up to 90% of recurrent nasal polyps in patients with CRSwNP have predominantly eosinophilic inflammation. In a retrospective study, nasal polyp recurrence was 3 times greater in patients with elevated eosinophils after surgery.

ONSCREEN TEXT:
IL-5 Is Often Elevated in Nasal Polyp Tissue and Is Key for Eosinophil Survival^6,7

IL-5 is the key cytokine responsible for the growth, recruitment, and survival of eosinophils⁶

[image of an IL-5s and Eosinophil to show correlation]

Increased IL-5 is correlated with recurrent nasal polyps^2,8,9

DR. FRANZESE:
IL-5 is often elevated in nasal polyp tissue and is key for eosinophil survival. IL-5 is the key cytokine responsible for the growth, recruitment, and survival of eosinophils. Also, increased IL-5 is correlated with recurrent nasal polyps.

ONSCREEN TEXT:
NUCALA (mepolizumab) Inhibits Il-5, With Rapid Reduction in Blood Eosinophils^10,11
NUCALA is a humanized IL-5 antagonist monoclonal antibody.
[image of How NUCALA works]
The MOA of mepolizumab has not been definitively established.

NUCALA binds to IL-5 and blocks its binding to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface

This inhibits IL-5 signaling and reduces the production and survival of eosinophils

NUCALA reduced blood eosinophils by 74% within 48 hours.^11‡

Results are descriptive. The clinical significance of these pharmacodynamics data is unknown.

^‡ Data based on mepolizumab 75 mg IV (n=10) at first measurement post-dose from a phase 2 study in 70 adult patients with asthma and blood eosinophil counts ≥200 cells/μL (mean baseline blood is eosinophils: 348 cells/μL).^10,11 Blood is eosinophil reduction data or based on geometric mean.

DR. FRANZESE:
NUCALA is a humanized IL-5 antagonist monoclonal antibody that binds to IL-5 and blocks its binding to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface. This inhibits IL-5 signaling and reduces the production and survival of eosinophils.

Please note the mechanism of action of mepolizumab has not been definitively established.

In a phase 2 study in asthma patients, NUCALA reduced blood eosinophils by 74% within 48 hours. These results are descriptive. The clinical significance of these pharmacodynamics data is unknown.

ONSCREEN TEXT:
Clinical Trial in Patients With Recurrent CRSwNP (SYNAPSE Trial)¹²

SYNAPSE: Multicenter, randomized, double-blind, phase 3 trial (N=407)
[table showing select inclusion criteria and Co-Primary endpoints of the study]

Select Inclusion Criteria:

Adults with bilateral CRSwNP

≥1 prior surgery^§ for nasal polyps within 10 years

≥8 weeks of intranasal corticosteroid therapy

Met criteria for severe nasal obstruction

Eligible for repeat nasal surgery^¶

52 Weeks (treatment every 4 weeks + SOC^#)

NUCALA (mepolizumab) 100 mg SC (n=206)

Placebo SC (n=201)

Co-Primary Endpoints:

Change from baseline in total endoscopic nasal polyp score at Week 52

Change from baseline in nasal obstruction symptom score at Weeks 49-52

^§Defined as polypectomy in sinonasal cavity.
^‖Defined as a nasal obstruction symptom score of >5 (of 10).
^¶Defined as an overall symptom score of >7 (of 10) and endoscopic nasal polyp score of ≥5 (of 8), with a minimum score of 2 in each nasal cavity.
^#Daily mometasone furoate nasal spray in addition to saline nasal irrigations and courses of systemic corticosteroids and/or antibiotics as required.

DR. FRANZESE:
The efficacy and safety of NUCALA in CRSwNP was studied in SYNAPSE—a 52-week, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. It studied NUCALA 100 mg versus placebo subcue once every 4 weeks added to standard-of-care therapy in adult patients with recurrent CRSwNP. Standard of care was daily mometasone furoate nasal spray in addition to saline nasal irrigations and courses of systemic corticosteroids and/or antibiotics as required.

Note that patients who were included were required to have at least 1 surgery for nasal polyps in the last 10 years and be eligible for repeat nasal surgery. Co-primary endpoints were change from baseline in total endoscopic nasal polyp score at Week 52 and change from baseline in nasal obstruction score during Weeks 49 to 52.

ONSCREEN TEXT:
Enrolled Patients Had Severe Recurrent CRSwNP and Were Eligible for Surgery^11,12

[table showing select baseline characteristics of patients in the SYNAPSE study]
Select Baseline Characteristics (N=407)**: Placebo (n=201); NUCALA (mepolizumab) (n=206)

Age, years: 49; 49
Male, %: 62; 67
Blood eosinophils, geometric mean (cells/μL): 400; 390
Duration of CRSwNP, years: 11.5; 11.4
Previous Surgery, %
   ≥1: 100; 100
   ≥2: 60; 48
   ≥3: 36; 25
≥1 course of OCS for CRSwNP in previous year, %: 45; 51

^**Values are mean unless otherwise noted.
^††VAS score, a patient-reported outcome tool.
^‡‡Scores >50 considered severe.¹³

DR. FRANZESE:
Shown here are select baseline characteristics of patients in the SYNAPSE study.
We see an elevated blood eosinophil count, a long duration of disease, and approximately half used oral corticosteroids in the previous year.

ONSCREEN TEXT:
Enrolled Patients Had Severe Recurrent CRSwNP and Were Eligible for Surgery^11,12

[table showing select baseline characteristics of patients in the SYNAPSE study, continued]
Select Baseline Characteristics (N=407)^**: Placebo (n=201); NUCALA (mepolizumab) (n=206)
Total endoscopic nasal polyps score (0-8): 5.6; 5.4
Nasal obstruction VAS score (0-10) ^††: 9.1; 8.9
Overall symptoms VAS score^††: 9.1; 9.0
Loss of smell VAS score (0-10) ^††: 9.7; 9.6
SNOT-22 total score (0-110) ^‡‡: 64.4; 63.7
Comorbid asthma, %: 74; 68
AERD, %; 31: 22

^**Values are mean unless otherwise noted.
^††VAS score, a patient-reported outcome tool.
^‡‡Scores >50 considered severe.¹³

DR. FRANZESE:
All patients in SYNAPSE had severe recurrent nasal polyps and were eligible for repeat surgery.
Health-related quality of life was severely impacted. We also see high prevalence of comorbid asthma at 71%.

ONSCREEN TEXT:
Total Endoscopic Nasal Polyp Score With NUCALA (mepolizumab)^11,12
(sum of both nostrils ranged from 0-8)

[image of nostrils with 0 to 4 polyps: 0-No polyps; 1-Middle meatus, not below inferior border of the middle concha; 2-Below the lower border of the MT; 3-Reaching lower border of the IT or medial to middle concha; 4-Complete obstruction of the inferior meatus]

Total Endoscopic Nasal Polyp Score at Baseline (N=407)
[image of range of Nasal Polyp Score: (0-8) with baseline sitting at 5.5]

DR. FRANZESE:
Here is the scoring scale for the Total Endoscopic Nasal Polyp Score in SYNAPSE. It is graded for each nostril with a sum of both nostrils ranging from 0 to 8. The mean baseline score in SYNAPSE was 5.5.

ONSCREEN TEXT:
Significant Improvement in Total Endoscopic Nasal Polyp Size With NUCALA (mepolizumab)^11,12
[bar chart showing LS mean^§§ change in nasal polyp size with NUCALA (n=206) compared to placebo (n=201). The co-primary endpoint of LS mean^§§ change from baseline in total endoscopic nasal polyp score at Week 52 was -0.87 with NUCALA vs 0.06 with placebo. P<0.001.]

^§§Least square (LS) means from an analysis using mixed-model repeated measures with covariates of treatment group, geographic region, baseline score, and log(e) baseline blood eosinophil count visit, interaction terms for visit by baseline, and visit by treatment.

DR. FRANZESE:
There was significant improvement in nasal polyp size with NUCALA compared with placebo.

The co-primary endpoint of least square mean change from baseline in total endoscopic nasal polyp score at Week 52 was -0.87 with NUCALA versus 0.06 with placebo. P was less than 0.001.

ONSCREEN TEXT:
Early and Sustained Improvements in Nasal Obstruction With NUCALA (mepolizumab)^11,12,14
[line graph showing LS mean^‖ change from baseline in symptoms of nasal obstruction from Week 0 to Weeks 49-52 for placebo (n=201) and NUCALA (n=206). The LS mean^‖ change from baseline in nasal obstruction VAS^¶¶ score at Weeks 49 to 52 was -4.40 with NUCALA vs -2.54 with placebo. P<0.001.]

[image of Nasal Obstruction Score at Baseline (N=407) Scale from 0 to 10, sitting at 9.]

^‖LS means from an analysis using mixed-model repeated measures.
^¶¶ VAS score, a patient-reported outcome tool.
Graph reprinted from Han JK, et al. Lancet Respir Med. 2021;S2213-2600(21)00097-7, Copyright 2021, with permission from Elsevier.

DR. FRANZESE:
Symptom severity was measured with a Visual Analogue Scale, a patient-reported outcome tool. It ranges from 0 for none to 10 for as bad as you can imagine. The mean baseline score for nasal obstruction VAS in SYNAPSE was 9.

There was a significant improvement in symptoms of nasal obstruction at Weeks 49 to 52 with NUCALA, a co-primary endpoint.

The LS mean change from baseline in nasal obstruction VAS score at Weeks 49 to 52 was -4.40 with NUCALA versus -2.54 with placebo. P was less than 0.001.

Also, note the early and sustained improvement in nasal obstruction over the 52 weeks. Results prior to Weeks 49 to 52 are descriptive.

ONSCREEN TEXT:
Improvement in CRSwNP Symptom Scores^11,12

[Three charts are shown for NUCALA (n=206) vs placebo (n=201) at Weeks 49-52: Secondary endpoints of Overall Symptom Score and Loss of Smell Score, and descriptive analysis for Improvements in Loss of Smell Score by number of prior Surgeries. The secondary endpoints demonstrated significant improvements (P<0.001). The decreases for NUCALA vs placebo were 4.40 vs 2.57 for Overall Symptom Score and 2.92 vs 1.46 for Loss of Smell Score.]

[chart of Greater Improvements in Loss of Smell Score with Fewer Surgeries. Results were 1 surgery (NUCALA n=108, -3.29 vs placebo n=81, -1.86); 2 surgeries (NUCALA n=47, -2.82 vs placebo n=47, -1.52); 3 or more surgeries (NUCALA n=51, -2.24 vs placebo n=73, -0.97); Results are descriptive.]

[image of Overall Symptom Score at Baseline (N=407) Scale from 0 to 10, sitting at 9.1.]
[image of Loss of Smell Symptom Score at Baseline (N=407) Scale from 0 to 10, sitting at 9.7.]

DR. FRANZESE:
The secondary endpoints of overall symptom score and loss of smell symptom score demonstrated significant improvements with P values of less than 0.001. As seen here, the decreases for NUCALA versus placebo were 4.40 vs 2.57 and 2.92 versus 1.46, respectively.

Also, there was a trend toward greater improvements in loss of smell scores that occurred in patients with fewer prior surgeries. These results are descriptive.

ONSCREEN TEXT:
Reduction in Nasal Polyp Surgery and Steroid Use for CRSwNP With NUCALA (mepolizumab)^11,12

57% reduction in proportion of patients who had surgery vs placebo
Key secondary endpoint: time to next surgery up to Week 52; NUCALA (n=18/206) vs placebo (n=46/201), HR: 0.43, P=0.0032.

DR. FRANZESE:
There was a 57% reduction in the proportion of patients who had surgery versus placebo (P was equal to 0.0032). This was a key secondary endpoint of SYNAPSE.

ONSCREEN TEXT:
Reduction in Nasal Polyp Surgery and Steroid Use for CRSwNP With NUCALA (mepolizumab)^11,12

42% reduction in need for SCS vs placebo
Secondary endpoint: proportion of patients requiring SCS for CRSwNP up to Week 52;
NUCALA (n=52/206) vs placebo (n=74/201), OR: 0.58, P=0.02.

DR. FRANZESE:
Additionally, there was a 42% reduction in need for steroids versus placebo (P was equal to 0.02). This was another secondary endpoint of SYNAPSE.

ONSCREEN TEXT:
Adverse Reactions (AR) in CRSwNP^11,12

ARs With NUCALA (mepolizumab) (≥3%) and More Common Than Placebo in Patients With CRSwNP
[table of adverse reactions]
AR (%): Placebo (n=201); NUCALA (n=206)
Oropharyngeal pain: 5; 8
Arthralgia: 2; 6
Upper abdominal pain: 2; 3
Diarrhea: 2; 3
Pyrexia: 2; 3
Nasal dryness: <1; 3
Rash: <1; 3

Systemic reactions, including hypersensitivity:
<1% placebo, <1% NUCALA; manifestations included urticaria, erythema, and rash. One of the 3 reactions occurred on the day of dosing

Injection site reactions (eg, erythema, pruritus): <1% placebo, 2% NUCALA

Herpes zoster: 1% (n=3) placebo; <1% (n=1) NUCALA; no serious adverse events in patients receiving NUCALA

Immunogenicity: 3% (n=6) of patients receiving NUCALA developed anti-mepolizumab antibodies; no neutralizing antibodies were detected in any patients. The clinical relevance of anti-mepolizumab antibodies is not known

DR. FRANZESE:
The most common adverse reactions with NUCALA, with an incidence greater than or equal to 3% and more common than placebo, are shown here. They are oropharyngeal pain, arthralgia, upper abdominal pain, diarrhea, pyrexia, nasal dryness, and rash.

Less than 1% of patients who received NUCALA or placebo experienced systemic reactions. Manifestations included urticaria, erythema, and rash. One of the 3 reactions occurred on the day of dosing.

Less than 1% of patients who received placebo and 2% who received NUCALA reported injection site reactions such as erythema and pruritus.

One percent of patients who received placebo and less than 1% who received NUCALA reported herpes zoster. The event with NUCALA was not considered serious.

Three percent of patients receiving NUCALA developed anti-mepolizumab antibodies. No neutralizing antibodies were detected in any patients. The clinical relevance of anti-mepolizumab antibodies is not known.

DR. FRANZESE:
Now, please listen as the narrator presents additional Important Safety Information for NUCALA.

ONSCREEN TEXT:
IMPORTANT SAFETY INFORMATION (cont’d)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) in patients receiving NUCALA (mepolizumab):

Severe asthma trials: headache, injection site reaction, back pain, fatigue.

CRSwNP trial: oropharyngeal pain and arthralgia.

EGPA and HES trials (300 mg of NUCALA): no additional adverse reactions were identified to those reported in severe asthma clinical trials

Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

Please see Important Safety Information for NUCALA throughout this video.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com

NARRATOR:
Important Safety Information continued. ADVERSE REACTIONS: The most common adverse reactions, defined as greater than or equal to 5%, in patients receiving NUCALA in the severe asthma trials were headache, injection site reaction, back pain, fatigue. Those in the CRSwNP trial were oropharyngeal pain and arthralgia. In the EGPA and HES trials with 300 mg of NUCALA, no additional adverse reactions were identified to those reported in severe asthma clinical trials.

Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

ONSCREEN TEXT:
IMPORTANT SAFETY INFORMATION (cont’d)
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

Please see Important Safety Information for NUCALA throughout this video.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com

NARRATOR:
USE IN SPECIFIC POPULATIONS:
The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

Please see full Prescribing Information and Patient Information for NUCALA at the adjacent links or visit NucalaHCP.com.

ONSCREEN TEXT:
This program is sponsored by GSK. Thank you for your participation.
Presentation intended for US healthcare providers only.
[GSK logo]

Trademarks are owned by or licensed to the GSK group of companies.
©2023 GSK or licensor.
MPLVID230003 April 2023
Produced in USA.

NARRATOR:
This program is sponsored by GSK. Thank you for your participation.

ONSCREEN TEXT:
Acronyms
AERD=aspirin-exacerbated respiratory disease; AR=adverse reaction; CRSwNP=chronic rhinosinusitis with nasal polyps; EGPA=eosinophilic granulomatosis with polyangiitis; HES=hypereosinophilic syndrome; HR=hazard ratio; IL=interleukin; IV=intravenous; IT=inferior turbinate; LS=least squares; MOA=mechanism of action; MT=middle turbinate; OCS=oral corticosteroids; SC=subcutaneous; SCS=systemic corticosteroids; SEA=severe eosinophilic asthma; SNOT-22=Sino-nasal Outcome Test (22-item); SOC=standard of care; VAS=visual analogue scale.

ONSCREEN TEXT:

References

Tosun F, Arslan HH, Karslioglu Y, et al. Relationship between postoperative recurrence rate and eosinophil density of nasal polyps. Ann Otol Rhinol Laryngol. 2010;119(7):455-459.

Van Zele T, Holtappels G, Gevaert P, Bachert C. Differences in initial immunoprofiles between recurrent and nonrecurrent chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2014;28(3):192-198.

Lou H, Meng Y, Piao Y, et al. Cellular phenotyping of chronic rhinosinusitis with nasal polyps. Rhinology. 2016;54(2):150-159.

Stoop AE, van der Heijden HA, Biewenga J, van der Baan S. Eosinophils in nasal polyps and nasal mucosa: an immunohistochemical study. J Allergy Clin Immunol. 1993;91(2):616-622.

Fujieda S, Imoto Y, Kato Y, et al. Eosinophilic chronic rhinosinusitis. Allergol Int. 2019;68(4):403-412.

Park YM, Bochner BS. Eosinophil survival and apoptosis in health and disease. Allergy Asthma Immunol Res. 2010;2(2):87-101.

Bachert C, Gevaert P, Holtappels G, Johansson SG, Cauwenberge P. Total and specific IgE in nasal polyps is related to local eosinophilic inflammation. J Allergy Clin Immunol. 2001;107(4):607-614.

Tomassern P, Vandeplas G, Van Zele T, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016;137(5):1449-1456.e4.

Bachert C, Zhang N, Hellings PW, Bousquet J. Endotype-driven care pathways in patients with chronic rhinosinusitis.J Allergy Clin Immunol. 2018;141(5):1543-1551.

Pouliquen IJ, Kornmann O, Barton SV, Price JA, Ortega HG. Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab. J Clin Pharmacol Ther. 2015;53(12):1015-1027.

Data on file, GSK.

Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.

Toma S, Hopkins C. Stratification of SNOT-22 scores into mild, moderate or severe and relationship with other subjective instruments. Rhinology. 2016:54(2);129-133.

Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps. Rhinology. 2020;58(suppl S29):1-464.

ONSCREEN TEXT:

Chapter 3 Voiceover References:

Tosun F, Arslan HH, Karslioglu Y, et al. Relationship between postoperative recurrence rate and eosinophil density of nasal polyps. Ann Otol Rhinol Laryngol. 2010;119(7):455-459.

Van Zele T, Holtappels G, Gevaert P, Bachert C. Differences in initial immunoprofiles between recurrent and nonrecurrent chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2014;28(3):192-198.

Lou H, Meng Y, Piao Y, et al. Cellular phenotyping of chronic rhinosinusitis with nasal polyps. Rhinology. 2016;54(2):150-159.

Stoop AE, van der Heijden HA, Biewenga J, van der Baan S. Eosinophils in nasal polyps and nasal mucosa: an immunohistochemical study. J Allergy Clin Immunol. 1993;91(2):616-622.

Fujieda S, Imoto Y, Kato Y, et al. Eosinophilic chronic rhinosinusitis. Allergol Int. 2019;68(4):403-412.

Park YM, Bochner BS. Eosinophil survival and apoptosis in health and disease. Allergy Asthma Immunol Res. 2010;2(2):87-101.

Bachert C, Gevaert P, Holtappels G, Johansson SG, Cauwenberge P. Total and specific IgE in nasal polyps is related to local eosinophilic inflammation. J Allergy Clin Immunol. 2001;107(4):607-614.

Tomassen P, Vandeplas G, Van Zele T, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016;137(5):1449-1456.e4.

Bachert C, Zhang N, Hellings PW, Bousquet J. Endotype-driven care pathways in patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2018;141(5):1543-1551.

Data on file, GSK.

Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.

Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps. Rhinology. 2020;58(suppl S29):1-464.