NUCALA efficacy in CRSwNP

On this page:

Reduction in nasal polyp size and symptom scores

Reduction in nasal polyp surgery

Reduction in steroids for nasal polyps

Quality-of-life data (SNOT-22)

Reduction in nasal polyp size and symptom scores

Early and sustained improvements
in nasal obstruction^1,2*

Significant improvement in nasal obstruction symptom. Co-primary endpoint.Weeks 49-52, P<0.001.^1,2

Results prior to Weeks 49-52 are descriptive.

Significant improvement in nasal polyp size.

Co-primary endpoint. LS mean^† change from baseline in total endoscopic nasal polyp score^‡ at Week 52: NUCALA, –0.87 (baseline: 5.4) vs placebo, 0.06 (baseline: 5.6), P<0.001.^1,2

^*Symptom severity measured on patient-reported VAS from 0 (none) to 10 (as bad as you can imagine).

^†LS means from an analysis using mixed model repeated measures.

^‡Total scores (sum of scores for both nostrils) ranged from 0 to 8. Reduction in score indicates improvement.

Improvement in other nasal polyp symptom scores*

LS mean^† change from baseline (Weeks 49-52)

Overall symptoms and loss of smell graph

Greater improvements in loss of smell score with fewer prior surgeries

Number of prior surgeries (placebo/NUCALA)	LS mean change from baseline Weeks 49-52
Number of prior surgeries (placebo/NUCALA)	Placebo	NUCALA
1 surgery (n=81/108)	-1.86	-3.29
2 surgery (n=47/47)	-1.52	-2.82
≥3 surgeries (n=73/51)	-0.97	-2.24
Results are descriptive.

Nasal discharge mucus in throat and facial pain graph

Not multiplicity-adjusted endpoints. Results are descriptive.

^*Symptom severity measured on patient-reported VAS from 0 (none) to 10 (as bad as you can imagine).

^†LS mean from an analysis using mixed model repeated measures.

^‡Patient evaluation of overall nasal polyp symptoms recorded daily.

View full study design

Reduction in nasal polyp surgery

Proven protection

against surgery

57%

reduction

in proportion of patients

who had surgery vs placebo¹

Subgroup of patients with

blood eosinophils ≥300 cells/µL

69%

reduction

in proportion of patients who had

surgery vs placebo²

NUCALA + SOC (n=10/139) vs placebo + SOC (n=35/139), HR: 0.31 (95% CI: 0.15, 0.64)

<300 cells/μL: NUCALA + SOC (n=8/67) vs placebo + SOC (n=11/62), HR: 0.83 (95% CI: 0.33, 2.09)

Post hoc analysis. Results are descriptive.

View full study design

Reduction in steroids for nasal polyps

Proven reduction

42%

reduction

in need for SCS vs placebo¹

Subgroup of patients with

blood eosinophils ≥300 cells/µL

51%

reduction

in need for SCS vs placebo²

NUCALA + SOC (n=37/139) vs placebo + SOC (n=58/139), OR: 0.49 (95% CI: 0.28, 0.86)

<300 cells/μL: NUCALA + SOC (n=15/67) vs placebo + SOC (n=16/62), OR: 0.88 (95% CI: 0.36, 2.16)

Post hoc analysis. Results are descriptive.

View full study design

Improvement in quality of life as measured by 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

Patients who met

responder criteria^†

73%

of patients

had a clinically important difference

in SNOT-22 on NUCALA vs 54% on placebo at Week 52¹

Other endpoint. Results are descriptive.

NUCALA + SOC (n=205) vs placebo + SOC (n=198), OR: 2.44

(95% CI: 1.60, 3.73).

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).^2,3

View full study design

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

Questions

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

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

View full study design

CI=confidence interval; HR-hazard ratio; LS: least squares; OR=odds ratio; SCS=systemic corticosteroids (injection and oral); SNOT-22=sino-nasal outcome test (22-item); SOC=standard of care; VAS=visual analogue scale.

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

-3.5

-10

Placebo + SOC

(n=201)

vs

NUCALA + SOC

(n=206)

Results are descriptive.

Baseline: 23
Questions (point range: 0-30):

Need to blow 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

-2

Placebo + SOC

(n=201)

vs

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

-4

Placebo + SOC

(n=201)

vs

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

-3

Placebo + SOC

(n=201)

vs

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

-5

Placebo + SOC

(n=201)

vs

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

-3

Placebo + SOC

(n=201)

vs

NUCALA + SOC

(n=206)

Results are descriptive.

Baseline: 7
Questions (point range: 0-15):

Frustrated/restless/irritable

Sad

Embarrassed

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

View full study design

Next: Comorbidity data

Dosing & administration

Access & support

Indication & Important Safety Info

Indication

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.

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.

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

Important Safety Information

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.
MPLWCNT230012 May 2023

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 [published online ahead of print, April 16, 2021]. Lancet Respir Med. https://doi.org/10.1016/S2213-2600(21)00097-7. Supplementary Appendix.
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. 34(5), 447-454.

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

Trademarks are owned by or licensed to the GSK group of companies.

This is my caption

Reduction in nasal polyp size and symptom scores

Improvement in other nasal polyp symptom scores*

Reduction in nasal polyp surgery

57%

69%

Reduction in steroids for nasal polyps

42%

51%

Improvement in quality of life as measured by SNOT-22

73%

SNOT-22: Symptom and impact improvement in ALL 6 domains‡

Questions

References

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