NUCALA HAS A WELL-ESTABLISHED SAFETY PROFILE

In the 52-week MIRRA EGPA trial, no additional adverse reactions were identified to those reported in the severe asthma trials*†

ADVERSE REACTIONS (≥20% INCIDENCE AND MORE COMMON THAN PLACEBO) IN 52-WEEK MIRRA TRIAL1

Adverse reaction NUCALA 300 mg (n=68) % Placebo (n=68) %
Headache 32 18
Arthralgia 22 18
Sinusitis 21 16
Upper respiratory tract infection 21 16

IN THE EGPA TRIAL USING 300 MG OF NUCALA

  • Systemic reactions, including hypersensitivity: 6% NUCALA, 1% placebo
    • Manifestations included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, and angioedema. 2 of the 4 reactions occurred on the day of dosing
  • Injection site reactions (eg, pain, erythema, swelling): 15% NUCALA, 13% placebo
  • Serious AEs: 18% NUCALA, 26% placebo. Drug-related‡: 4% NUCALA and placebo1
  • Immunogenicity: In patients receiving NUCALA, <2% (n=1) developed anti-mepolizumab antibodies and none had neutralizing antibodies detected. The clinical relevance of anti-mepolizumab antibodies is not known
  • There were no serious adverse events of herpes zoster in patients receiving NUCALA

Severe asthma reactions (%, ≥3% incidence and more common than placebo) in patients with asthma in the first 24 weeks of Trial 2* and Trial 3† with NUCALA 100 mg (n=263) vs placebo (n=257): headache (19 vs 18); injection site reaction (8 vs 3); back pain (5 vs 4); fatigue (5 vs 4); influenza (3 vs 2); urinary tract infection (3 vs 2); abdominal pain upper (3 vs 2); pruritus (3 vs 2); eczema (3 vs <1); muscle spasms (3 vs <1).

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.

*Severe Asthma Trial 2: 32-week exacerbation reduction trial.

†Severe Asthma Trial 3: 24-week OCS reduction trial.

‡Considered related by the investigator.1

Pivotal study design

The ONLY FDA-approved EGPA biologic with safety data up to 7.4 years2

In an open-label, long-term access study of NUCALA,* the safety profile of NUCALA was similar to that of MIRRA, with no new safety issues identified in EGPA patients aged ≥18 years.

Mean (range) exposure to NUCALA: 38.5 months (3.2 years) with a range of 1 to 89 months (7.4 years).

ADVERSE EVENTS IN OPEN-LABEL, LONG-TERM ACCESS STUDY (UP TO 7.4 YEARS)

NUCALA adverse events in open-label, long-term access study up to 7.4 years NUCALA adverse events in open-label, long-term access study up to 7.4 years
71 percent of patients completed this study image 71 percent of patients completed this study image

Patient discontinuations were due to AE (3%), lack of efficacy (4%), or other (22%).

Most common serious AEs (≥3%): worsening of asthma (6%), pneumonia (3%), and worsening of EGPA (3%).

Most common non-serious AEs (≥20%): nasopharyngitis (33%), upper respiratory tract infection (31%), worsening of asthma (30%), sinusitis (30%), bronchitis (29%), and arthralgia (20%).

*Safety population included patients who received ≥1 NUCALA dose.

†Serious AEs were those that resulted in death, were life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in disability/incapacity, resulted in a congenital anomaly/birth defect, or were associated with liver injury and impaired liver function.

‡As determined by the investigator.

§Severe dyspnea, hypoxia, cardiac arrest; not considered related to study treatment.

llNon-serious AEs were any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment.

¶Defined as patients who remained in the open-label, long-term study and received NUCALA until the study end, which coincided with when it became commercially licensed for EGPA in the relevant country.

7.4-year open-label study design

AE=adverse event; OCS=oral corticosteroid.

See NUCALA dosing and administration

Choose to administer NUCALA in-office, or offer patients the option to self-administer at home

Lyophilized powder vials image

Lyophilized powder for in-office reconstitution and administration

Consider in-office dosing and administration for appropriate patients.

IN-OFFICE ADMINISTRATION

NUCALA Autoinjectors

The NUCALA Autoinjector for at-home administration

Consider at-home administration with the NUCALA Autoinjector for appropriate patients.

AT-HOME ADMINISTRATION

Lyophilized powder vials image

Lyophilized powder for in-office reconstitution and administration

Consider in-office dosing and administration for appropriate patients.

IN-OFFICE ADMINISTRATION

NUCALA autoinjectors

The NUCALA Autoinjector for at-home administration

Consider at-home administration with the NUCALA Autoinjector for appropriate patients.

AT-HOME ADMINISTRATION