NUCALA IMPROVED QUALITY OF LIFE, BASED ON SNOT-22

Significant improvement in median change in SNOT-22 total score* from baseline at Week 52 (secondary endpoint): NUCALA + SOC (n=206; baseline, 64), 30-point improvement; placebo + SOC (n=201; baseline, 64), 14-point improvement; P=0.0032.^1,2

PATIENTS WHO MET RESPONDER CRITERIA†

73% of patients had a clinically important difference in SNOT-22 on NUCALA vs 54% on placebo at Week 52 and met responder criteria infographic

Other endpoint. Results are descriptive.
NUCALA + SOC (n=205) vs placebo + SOC (n=198), OR: 2.44 (95% CI: 1.60, 3.73).

*SNOT-22: Health-related quality-of-life tool that assesses symptoms and impact associated with CRS.³
†Defined as a reduction in SNOT-22 total score of ≥8.9 points in the absence of surgery for minimum clinically important difference (MCID).^1,3

SYNAPSE study design

SNOT-22: Symptom and impact improvement in all 6 domains^2‡

‡SNOT-22 not designed to measure changes in individual questions.

SYNAPSE study design

Questions^2,3

Nasal

Need to blow nose
Nasal blockage
Sneezing
Runny nose
Thick nasal discharge
Decrease sense of smell/taste

Non-nasal

Cough
Post-nasal discharge

Ear/facial

Ear fullness
Dizziness
Ear pain
Facial pain

Sleep

Difficulty falling asleep
Wake up at night
Lack of good night’s sleep

Fatigue

Wake up tired
Fatigue
Reduced productivity
Reduced concentration

Emotional consequences

Frustrated/restless/irritable
Sad
Embarrassed

CI=confidence interval; OR=odds ratio; SNOT-22: sino-nasal outcome test (22-item); SOC=standard of care.

SNOT-22: Symptom and impact improvement in all 6 domains^2‡

Nasal
Median change from baseline in domain scores at Week 52^2,3

–3.5

Placebo + SOC 

(n= 201)

vs

–10

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 23

Questions (point range: 0-30):

Need to blow my nose

Nasal blockage

Sneezing

Runny nose

Thick nasal discharge

Decrease sense of smell/taste
Non-nasal
Median change from baseline in domain scores at Week 52^2,3

0

Placebo + SOC 

(n= 201)

vs

–2

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 6

Questions (point range: 0-10):

Cough

Post-nasal discharge
Ear/facial
Median change from baseline in domain scores at Week 52^2,3

–1

Placebo + SOC 

(n= 201)

vs

–4

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 9

Questions (point range: 0-20):

Ear fullness

Dizziness

Ear pain

Facial pain
Sleep
Median change from baseline in domain scores at Week 52^2,3

–1

Placebo + SOC 

(n= 201)

vs

–3

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 9

Questions (point range: 0-15):

Difficulty falling asleep

Wake up at night

Lack of good night’s sleep
Fatigue
Median change from baseline in domain scores at Week 52^2,3

–1

Placebo + SOC 

(n= 201)

vs

–5

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 12

Questions (point range: 0-20):

Wake up tired

Fatigue

Reduced productivity

Reduced concentration
Emotional consequences
Median change from baseline in domain scores at Week 52^2,3

0

Placebo + SOC 

(n= 201)

vs

–3

NUCALA + SOC

(n= 206)

Results are descriptive.
Baseline: 7

Questions (point range: 0-15):

Frustrated/restless/ irritable

Sad

Embarrassed

All results are descriptive.

‡SNOT-22 not designed to measure changes in individual questions.

SYNAPSE study design

CI=confidence interval; OR=odds ratio; SNOT-22: sino-nasal outcome test (22-item); SOC=standard of care.

Learn about the data for NUCALA in patients with comorbidities

SEE COMORBIDITY DATA

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

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.

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

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.

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.
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.
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 ≥6 months without an identifiable non-hematologic secondary cause.

IMPORTANT SAFETY INFORMATION

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.

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, 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.

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.

ADVERSE REACTIONS

Most common adverse reactions (≥5%) in patients receiving NUCALA:

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

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.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

MPLWCNT240005 April 2024

References

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.

Data on file, GSK.

Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447-454. Supplementary Appendix.

NUCALA IMPROVED QUALITY OF LIFE, BASED ON SNOT-22

PATIENTS WHO MET RESPONDER CRITERIA†

SNOT-22: Symptom and impact improvement in all 6 domains2‡

Questions2,3

SNOT-22: Symptom and impact improvement in all 6 domains2‡

All results are descriptive.

References

SNOT-22: Symptom and impact improvement in all 6 domains^2‡

Questions^2,3

SNOT-22: Symptom and impact improvement in all 6 domains^2‡