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Powerful and lasting protection up to 4.8 years 1

Nucala: The only anti-IL-5 proven to demonstrate powerful and lasting reduction in exacerbations and OCS dose for up to 4.8 years. 1 2 3

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Powerful and lasting reduction in exacerbations 12

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Powerful reductions in exacerbations 25

  • MUSCA study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 4 study assessing the effect of mepolizumab and placebo added to SoC on disease specific HR-QoL using the St. George’s Respiratory Questionnaire (SGRQ) in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months). Primary endpoint was the mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24.

  • See similar data from MENSA (32 weeks)

  • MENSA study design

    32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled phase 3 study comparing treatment with NUCALA 100mg SC or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months). MENSA aimed to confirm the exacerbation reduction with the 75mg IV dose and to show comparability of the 100mg SC dose. Primary endpoint was the annualized frequency of clinically significant exacerbations (OCS for 3 or more days or ED or hospitalization).

Lasting reductions in exacerbations for up to 4.8 years 1

  • MENSA study design

    32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled phase 3 study comparing treatment with NUCALA 100mg SC or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months). MENSA aimed to confirm the exacerbation reduction with the 75mg IV dose and to show comparability of the 100mg SC dose. Primary endpoint was the annualized frequency of clinically significant exacerbations (OCS for 3 or more days or ED or hospitalization).

  • COSMOS study design

    52-week, multicenter, open-label extension study assessing the long-term safety and efficacy of NUCALA in 651 patients with severe asthma with an eosinophilic phenotype who completed MENSA or SIRIUS. All patients in the COSMOS study received NUCALA added to SoC regardless of their previous treatment allocation (NUCALA, mepolizumab 75mg IV or placebo). The primary endpoint was long-term safety, including adverse events and severe adverse events.

  • COSMEX study design

    Multicenter, open-label, long-term, single-arm, extension study assessing the safety and efficacy of NUCALA in 340 patients with severe asthma with an eosinophilic phenotype who were given mepolizumab 100mg SC every 4 weeks in addition to SOC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given mepolizumab until they met protocol-defined stopping criterion. The median duration of mepolizumab treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years), max exposure to mepolizumab for patients in COSMEX was up to 4.8 years. The primary endpoints were adverse event frequency and exacerbation rate/year.  Forced expiratory volume in 1s (FEV1), Asthma Control Questionnaire (ACQ)-5 score and daily oral corticosteroid (OCS) use were also assessed.


Reduction beyond benralizumab (indirect treatment comparison) 7

No head-to-head studies exist that allow a direct comparison of the efficacy of Nucala vs. benralizumab. 7
In an indirect comparison, Nucala offered significantly greater reduction in clinically significant exacerbations vs. benralizumab in patients with severe eosinophilic asthma. 7

  • Indirect Treatment Comparison methodology

    Anti-IL-5 indirect treatment comparison
    A published meta-analysis to compare the efficacy of licensed doses of mepolizumab, benralizumab, and reslizumab in patients with severe eosinophilic asthma, according to baseline blood eosinophil counts.  No head-to-head comparisons are available, therefore this indirect treatment comparison (ITC) used data from eleven published analyses identified through a Cochrane review and independent searches.  Five of the published analyses were used to compare Nucala and benralizumab and an additional six were used to make additional comparisons with reslizumab. Eligible studies were randomised controlled trials using the licensed dose in patients aged ≥12 years with severe eosinophilic asthma.  The ITC was performed in all patients with ACQ ≥1.5 and stratified by baseline blood eosinophil counts.  The primary endpoints were exacerbation reduction and change from baseline ACQ score. Change from baseline in pre-bronchodilator FEV1 was a secondary endpoint.

See also:

OCS-dose reduction

Eosinophil reduction

Long-term safety

Paediatric data

Additional data

Power to Choose: at home or in office administration

Powerful and lasting reduction in OCS dose 13

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Powerful reductions in OCS dose 39

  • SIRIUS study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 3 study to investigate the efficacy and safety of mepolizumab to reduce the use of OCS while maintaining asthma control.  Treatment with NUCALA was compared to placebo in 135 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL in the past 12 months). Patients were on 5 to 35 mg of prednisone or its equivalent per day for the prior 6 months, in addition to regular use of high-dose ICS plus an additional controller. Patients were not required to have a history of exacerbations in the previous 12 months. Primary endpoint was the percent reduction in daily OCS dose (weeks 20 to 24) while maintaining asthma control.

  • COSMOS study design

    52-week, multicenter, open-label extension study assessing the long-term safety and efficacy of NUCALA in 651 patients with severe asthma with an eosinophilic phenotype who completed MENSA or SIRIUS. All patients in the COSMOS study received NUCALA added to SoC regardless of their previous treatment allocation (NUCALA, mepolizumab 75mg IV or placebo). The primary endpoint was long-term safety, including adverse events and severe adverse events.

Lasting reduction in OCS dose up to 4.8 years* 13

  • SIRIUS study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 3 study to investigate the efficacy and safety of mepolizumab to reduce the use of OCS while maintaining asthma control. Treatment with NUCALA was compared to placebo in 135 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL in the past 12 months). Patients were on 5 to 35 mg of prednisone or its equivalent per day for the prior 6 months, in addition to regular use of high-dose ICS plus an additional controller. Patients were not required to have a history of exacerbations in the previous 12 months. Primary endpoint was the percent reduction in daily OCS dose (weeks 20 to 24) while maintaining asthma control.

  • COSMOS study design

    52-week, multicenter, open-label extension study assessing the long-term safety and efficacy of NUCALA in 651 patients with severe asthma with an eosinophilic phenotype who completed MENSA or SIRIUS. All patients in the COSMOS study received NUCALA added to SoC regardless of their previous treatment allocation (NUCALA, mepolizumab 75mg IV or placebo). The primary endpoint was long-term safety, including adverse events and severe adverse events.

  • COSMEX study design

    Multicenter, open-label, long-term, single-arm, extension study assessing the safety and efficacy of NUCALA in 340 patients with severe asthma with an eosinophilic phenotype who were given mepolizumab 100mg SC every 4 weeks in addition to SOC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given mepolizumab until they met protocol-defined stopping criterion. The median duration of mepolizumab treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years), max exposure to mepolizumab for patients in COSMEX was up to 4.8 years. The primary endpoints were adverse event frequency and exacerbation rate/year.  Forced expiratory volume in 1s (FEV1), Asthma Control Questionnaire (ACQ)-5 score and daily oral corticosteroid (OCS) use were also assessed.

See also:

Exacerbation reduction

Eosinophil reduction

Long-term safety

Paediatric data

Additional data

Power to Choose: at home or in office administration

Lasting reductions in blood eosinophil levels without complete depletion 14

Back

Nucala is the only anti-IL-5 to demonstrate sustained reduction in blood eosinophils for up to 4.8 years 1

Too many eosinophils may lead to:1112

  • More severe asthma symptoms
  • Increased risk of exacerbations

Eosinophils play a role in maintaining health by helping to:1314

  • Regulate the immune system
  • Defend the body from pathogens


Nucala: The only anti-IL-5 to demonstrate sustained reduction in blood eosinophils without complete depletion for up to 4.8 years 14

Low levels maintained for up to 4.8 years 1

  • COSMOS study design

    52-week, multicenter, open-label extension study assessing the long-term safety and efficacy of NUCALA in 651 patients with severe asthma with an eosinophilic phenotype who completed MENSA or SIRIUS. All patients in the COSMOS study received NUCALA added to SoC regardless of their previous treatment allocation (NUCALA, mepolizumab 75mg IV or placebo). The primary endpoint was long-term safety, including adverse events and severe adverse events.

  • COSMEX study design

    Multicenter, open-label, long-term, single-arm, extension study assessing the safety and efficacy of NUCALA in 340 patients with severe asthma with an eosinophilic phenotype who were given mepolizumab 100mg SC every 4 weeks in addition to SOC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given mepolizumab until they met protocol-defined stopping criterion. The median duration of mepolizumab treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years), max exposure to mepolizumab for patients in COSMEX was up to 4.8 years. The primary endpoints were adverse event frequency and exacerbation rate/year.  Forced expiratory volume in 1s (FEV1), Asthma Control Questionnaire (ACQ)-5 score and daily oral corticosteroid (OCS) use were also assessed.

See also:

Exacerbation reduction

OCS-dose reduction

Long-term safety

Paediatric data

Additional data

Power to Choose: at home or in office administration

Clinical trial safety data up to 4.8 years 1

Back

Nucala is the only anti-IL-5 with up to 4.8 years of clinical trial safety data 1

The long-term safety and immunogenicity profile of Nucala was similar to that seen in controlled asthma trials 1515

In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections. 6

  • COSMEX study design

    Multicenter, open-label, long-term, single-arm, extension study assessing the safety and efficacy of NUCALA in 340 patients with severe asthma with an eosinophilic phenotype who were given mepolizumab 100mg SC every 4 weeks in addition to SOC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given mepolizumab until they met protocol-defined stopping criterion. The median duration of mepolizumab treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years), max exposure to mepolizumab for patients in COSMEX was up to 4.8 years. The primary endpoints were adverse event frequency and exacerbation rate/year. Forced expiratory volume in 1s (FEV1), Asthma Control Questionnaire (ACQ)-5 score and daily oral corticosteroid (OCS) use were also assessed.

Most common AEs and SAEs in adults

Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within first 3 injections. 6

  • COLUMBA: Most frequent on-treatment AEs and SAEs [15]

  • COLUMBA study design

    Multicenter, open-label long-term study assessing the safety, immunogenicity and efficacy of NUCALA in 347 patients with severe asthma with an eosinophilic phenotype who completed DREAM at least 12 months prior and met eligibility criteria. All patients received NUCALA added to asthma controller therapy until protocol-defined stopping criteria was met.  Primary endpoint was long-term safety, including adverse events, serious adverse events and immunogenicity.

  • COSMEX study design

    Multicenter, open-label, long-term, single-arm, extension study assessing the safety and efficacy of NUCALA in 340 patients with severe asthma with an eosinophilic phenotype who were given mepolizumab 100mg SC every 4 weeks in addition to SOC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given mepolizumab until they met protocol-defined stopping criterion. The median duration of mepolizumab treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years), max exposure to mepolizumab for patients in COSMEX was up to 4.8 years. The primary endpoints were adverse event frequency and exacerbation rate/year.  Forced expiratory volume in 1s (FEV1), Asthma Control Questionnaire (ACQ)-5 score and daily oral corticosteroid (OCS) use were also assessed.

See also:

Exacerbation reduction

OCS-dose reduction

Eosinophil reduction

Paediatric data

Additional data

Power to Choose: at home or in office administration

Nucala in the paediatric patient population

Back

Indication:
Severe Eosinophilic Asthma
NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 6 years and older

Dosage:

Adults and Adolescents (12 years and older)
The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children aged 6 to 11 years old:

Children weighing ≥ 40 kg
The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children weighing < 40 kg
The recommended dose is 40 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks

Data available in the paediatric patient population 16

Limited data were collected in patients under 18 years of age in the Nucala development programme. A small PK/PD study in children 6-11 years was conducted (Study 200363, n=36). To confirm the value of Nucala in the paediatric population, a 5-step extrapolation approach was taken.

Study

Paediatric subjects

Total subjects

Dose†

DREAM

1 (12 – 17 years)

616

75, 250, 750 mg IV

MENSA

25 (12 – 17 years)

576

75 mg IV 100 mg SC

SIRIUS

2 (12 – 17 years)

135

100 mg SC

MUSCA

9 (12 – 17 years)

551

100 mg SC

Study 200363

36 (6-11 years)

36

40, 100 mg SC*

40mg SC is licensed in patients aged 6-11 weighing less than 40kg, and 100mg SC is licensed in patients aged 6-11 weighing 40kg and over.

*Depending on subject bodyweight

  • DREAM study design

    52-week multicenter, randomized, double-blind dose ranging phase 2b/3 study comparing the effect of mepolizumab 75mg, 250mg, or 750mg IV and placebo IV added to SoC on exacerbation rates in 616 patients with severe uncontrolled refractory asthma defined as having had two or more exacerbations requiring systemic corticosteroid treatment in the previous year, and having evidence of eosinophilic inflammation within the previous year, identified by one of 4 possible parameters, including a blood eosinophil count of ≥300 cells/mL. Primary endpoint was the rate of clinically significant asthma exacerbations, which were defined as validated episodes of acute asthma requiring treatment with oral corticosteroids, admission or a visit to an emergency department.

  • MENSA study design

    32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled phase 3 study comparing treatment with NUCALA 100mg SC or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  MENSA aimed to confirm the exacerbation reduction with the 75mg IV dose and to show comparability of the 100mg SC dose. Primary endpoint was the annualized frequency of clinically significant exacerbations (OCS for 3 or more days or ED or hospitalization). 

  • SIRIUS study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 3 study to investigate the efficacy and safety of mepolizumab to reduce the use of OCS while maintaining asthma control.  Treatment with NUCALA was compared to placebo in 135 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL in the past 12 months). Patients were on 5 to 35 mg of prednisone or its equivalent per day for the prior 6 months, in addition to regular use of high-dose ICS plus an additional controller. Patients were not required to have a history of exacerbations in the previous 12 months. Primary endpoint was the percent reduction in daily OCS dose (weeks 20 to 24) while maintaining asthma control.

  • MUSCA study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 4 study assessing the effect of mepolizumab and placebo added to SoC on disease specific HR-QoL using the St. George’s Respiratory Questionnaire (SGRQ) in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  Primary endpoint was the mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24. 

  • Study 200363 (PK/PD paeds) study design

    Study 200363 was a open-label, single-arm, multi-center, two-part Phase II study conducted in children 6–11 years of age with severe eosinophilic asthma. Part A focused on the pharmacokinetics (PK) and pharmacodynamics (PD) of mepolizumab assessed over 12 weeks on treatment with an 8-week follow-up; Part B focused on long-term safety and PD. Children who had completed all treatments and assessments in Part A were eligible to enter Part B; participation was optional. In Part B, children received mepolizumab every 4 weeks (in addition to their baseline controller medications) for 52 weeks; those weighing ≥40 kg received 100 mg subcutaneously (SC) and those weighing <40 kg received 40 mg SC.

Adverse event profile in paediatric patients aged 6-11 years

Nucala was well tolerated in children 6–11 years of age with severe eosinophilic asthma, and no new safety concerns were identified for this age group compared with the known safety profile in adults/adolescents. 18

Study 200363 Part A: Adverse events in children aged 6-11 years. 17

Number (%) of Subjects

 

Mepolizumab
40mg SC
(n=26)

Mepolizumab
100mg SC
(n=10)

Overall
(n=36)

Any adverse event

20 (77)

6 (60)

26 (72)

Related to study treatment

8 (31)

3 (30)

11 (31)

Leading to withdrawal

1 (4)

0

1 (3)

Any serious adverse event

6 (23)

1 (10)

7 (19)

Related to study treatment

2 (8)

0

2 (6)

Fatal serious adverse event

0

0

0

Any on-treatment** adverse event

18 (69)

6 (60)

24 (67)*

Any on-treatment** severe adverse event

5 (19)

1 (10)

6 (17)

**Any AE commencing within 4 weeks of the last dose of Nucala.

*Overall phase 3 AE incidence was 82% for placebo and 79% for mepolizumab 100mg SC

Study 200363 Part B: Adverse events in children aged 6-11 years. 18

 

Mepo SC
40 mg
(N=16)

Mepo SC
100 mg
(N=10)

Mepo SC
40/100 mg*
(N=4)

Overall
(N=30)

Any AE

15 (94)

8 (80)

 4 (100)

27 (90)

Related to study treatment

5 (31)

3 (30)

1 (25)

9 (30)

Leading to withdrawal

0

0

0

0

Any Serious AE

4 (25)

2 (20)

1 (25)

7 (23)

Related to study treatment

0

0

0

0

Fatal serious AE

0

0

0

0

Any on-treatment** AE

15 (94)

8 (80)

4 (100)

27 (90)

Any on-treatment** severe AE

4 (25)

2 (20)

1 (25)

7 (23)

**Any AE commencing within 4 weeks of the last dose of Nucala.

*Subjects enrolled to <40 kg at Visit 9 are summarised in the 40/100 mg SC group if they had weight ≥40 kg at any subsequent visit.

In study 200363, patients under 40kg received a 40mg SC dose, and over 40kg received a 100mg dose. 16

  • Study 200363 (PK/PD paeds) study design

    Study 200363 was a open-label, single-arm, multi-center, two-part Phase II study conducted in children 6–11 years of age with severe eosinophilic asthma. Part A focused on the pharmacokinetics (PK) and pharmacodynamics (PD) of mepolizumab assessed over 12 weeks on treatment with an 8-week follow-up; Part B focused on long-term safety and PD. Children who had completed all treatments and assessments in Part A were eligible to enter Part B; participation was optional. In Part B, children received mepolizumab every 4 weeks (in addition to their baseline controller medications) for 52 weeks; those weighing ≥40 kg received 100 mg subcutaneously (SC) and those weighing <40 kg received 40 mg SC.

See also:

Exacerbation reduction

OCS-dose reduction

Eosinophil reduction

Long-term safety

Additional data

Power to Choose: at home or in office administration

Additional data

Back

Quick links:

Exacerbation reduction by baseline eosinophil levels

Exacerbation reduction by baseline IgE levels

Exacerbation reduction switching from omalizumab

Improvement in lung function

Improvement in Quality of Life

Exacerbation reduction by baseline eosinophil levels 20

Nucala demonstrates powerful reduction in exacerbations across eosinophil levels. Nucala reduced exacerbations in patients with blood eosinophil levels of ≥150 cells/μL. In a post-hoc analysis there was a trend for a greater reduction in exacerbations with increasing baseline eosinophil levels was observed  20

Reduction in frequency of clinically significant exacerbations vs. placebo by baseline blood eosinophil counts (MENSA Study Population)* 20

Post-hoc analysis of MENSA examining the rate of exacerbations across eosinophils count

*Data from all mepolizumab doses were combined for the analysis (75mg IV, 100mg SC).

  • MENSA study design

    32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled phase 3 study comparing treatment with NUCALA 100mg SC or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  MENSA aimed to confirm the exacerbation reduction with the 75mg IV dose and to show comparability of the 100mg SC dose. Primary endpoint was the annualized frequency of clinically significant exacerbations (OCS for 3 or more days or ED or hospitalization). 

Exacerbation reduction by baseline IgE levels 21

Nucala demonstrated powerful reductions in exacerbation across baseline IgE levels demonstrating the efficacy in patients with overlapping severe allergic and severe eosinophilic disease.* 21

Nucala reduced exacerbations by 55% in patients eligible for treatment with omalizumab and by 54% in patients who were ineligible for treatment with omalizumab.** 21

*Data from a post hoc meta-analysis of two Phase III, placebo-controlled, randomised, double-blind, parallel-group, multicentre studies (MENSA and MUSCA).21

**Eligibility defined as having a positive skin test for any of five aeroallergens (house dust mite, dog dander, cat dander, alternaria, and cockroach) and EU/Japan-specific body weight vs. pre-treatment serum IgE combinations.21

  • MENSA study design

    32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled phase 3 study comparing treatment with NUCALA 100mg SC or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months). MENSA aimed to confirm the exacerbation reduction with the 75mg IV dose and to show comparability of the 100mg SC dose. Primary endpoint was the annualized frequency of clinically significant exacerbations (OCS for 3 or more days or ED or hospitalization).

  • MUSCA study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 4 study assessing the effect of mepolizumab and placebo added to SoC on disease specific HR-QoL using the St. George’s Respiratory Questionnaire (SGRQ) in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  Primary endpoint was the mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24.

Exacerbation reduction switching from omalizumab 22

Nucala provides powerful reduction in exacerbations in uncontrolled patients directly switched from omalizumab.  Results show clinically significant reduction in exacerbations with Nucala vs. prior 12 months with omalizumab treatment*. Patients with uncontrolled severe eosinophilic asthma despite omalizumab use were directly switched to Nucala without requirement for a washout period. 22

*Secondary endpoint.

  • OSMO study design

    32-week, multicenter, open-label, single-arm study investigating the safety and efficacy of NUCALA treatment in 145 patients with severe eosinophilic asthma (with eos ≥150 cells/mL at baseline or ≥300 cells/mL in the past 12 months) and ≥2 exacerbations in the past year despite regular high-dose inhaled glucocorticoids plus other controller(s). Patients were required to have received omalizumab based on their criteria (for ≥ 4 months) and not be optimally controlled. The primary endpoint was mean change from baseline in ACQ-5 score at week 32.

Improvement in lung function* 2

Nucala demonstrated significant improvement in lung function vs. placebo from the first dose in the MUSCA study. FEV1 improvements vs placebo were seen from the first measurement at Week 4, and maintained throughout the study* 2.

*secondary endpoint; 24-week study.

  • MUSCA study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 4 study assessing the effect of mepolizumab and placebo added to SoC on disease specific HR-QoL using the St. George’s Respiratory Questionnaire (SGRQ) in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  Primary endpoint was the mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24. 

Improvement in Quality of Life 2

Nucala demonstrated significant improvement in quality of life (SGRQ) vs. placebo seen from week 4 and maintained throughout the study.2

**Primary endpoint; 24-week study.

  • MUSCA study design

    24-week multicenter, randomized, double-blind, placebo-controlled phase 4 study assessing the effect of mepolizumab and placebo added to SoC on disease specific HR-QoL using the St. George’s Respiratory Questionnaire (SGRQ) in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/mL at baseline or ≥300 cells/mL within the last 12 months).  Primary endpoint was the mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24. 

See also:

Exacerbation reduction

OCS-dose reduction

Eosinophil reduction

Long-term safety

Paediatric data

Power to Choose: at home or in office administration

Abbreviations:

ACQ, Asthma Control Questionnaire; CI, confidence interval; ED, emergency department; FEV1, forced expiratory volume in 1 second; HRQoL; health related quality of life; ICS, inhaled corticosteroids; IL, interleukin; IV, intravenous; OCS, oral corticosteroids; PD, pharmodynamic; PK, pharmokinetic; SAE, severe adverse events; SoC, standard of care; SQRG, St. George´s Respiratory Questionnaire

Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within first 3 injections. 6

Indication:
Severe Eosinophilic Asthma
NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 6 years and older

Dosage:

Adults and Adolescents (12 years and older)
The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children aged 6 to 11 years old:

Children weighing ≥ 40 kg
The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children weighing < 40 kg
The recommended dose is 40 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks

References:

  1. GlaxoSmithKline Data on File REF-26441.
  2. Chupp GL et al. Lancet Respir Med 2017; 5:390-400.
  3. Bel EH et al. N Engl J Med 2014; 371:1189-1197.
  4. Khatri S et al. J Allergy Clin Immunol 2019; 143:1742-1751.e7 (including supplementary materials).
  5. Ortega HG et al. N Engl J Med 2014; 371:1198-2107.
  6. Local Nucala Prescribing Information based on GDS 12.
  7. Busse W et al. J Allergy Clin Immunol 2019; 143:190-200.e20.
  8. Farne HA et al. Cochrane Database Syst Rev 2017; 9:CD010834.
  9. Lugogo N et al. Clin Ther 2016; 38:2058–2070.
  10. GINA. Difficult-to-treat & severe asthma in adolescent and adult patients.
  11. Price D et al. J Asthma Allergy 2016; 9:1-12.
  12. Garcia G et al. Eur Respir Rev 2013; 22:251-257.
  13. Wen T, Rothenburg ME. Microbiol Spectr 2016; 4(5): doi:10.1128/microbiolspec.MCHD-0020-2015.
  14. Weller PF, Spencer LA. Nat Rev Immunol 2017; 17:746-760.
  15. Khatri S et al. J Allergy Clin Immunol 2019; 143:1742-1751.e7.
  16. GlaxoSmithKline Data on File REF-2175.
  17. GlaxoSmithKline Data on File REF-2573.
  18. Steinfeld J, et al. Am J Respir Crit Care Med 2019;199:A7192.
  19. Ortega H et al. Am J Respir Crit Care Med 2018;197:A1367.
  20. Ortega HG et al. Lancet Respir Med 2016; 4:549–556.
  21. Humbert M et al. Resp Med. 2019; 154:69-75.
  22. Chapman KR, et al. Allergy. 2019. [Epub ahead of print]. doi: 10.1111/all.13850.

Nucala is registered trademark of the GlaxoSmithKline Group of Companies

Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within first 3 injections. 6