NUCALA HAS A WELL-ESTABLISHED SAFETY PROFILE WITH LONG-TERM DATA IN SEA

A total of 1327 patients ≥12 years of age with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration: Trial 1,* Trial 2, and Trial 3. Approximately 2% of patients receiving NUCALA withdrew from these clinical trials due to adverse events vs 3% of patients receiving placebo.

*Trial 1: 52-week dose-ranging exacerbation study.

NUCALA safety data in severe eosinophilic asthma (SEA)

ADVERSE REACTIONS ≥3% (AND MORE COMMON THAN PLACEBO) IN THE FIRST 24 WEEKS OF TRIAL 2 AND TRIAL 3

NUCALA adverse reactions from the first 24 weeks of Trials 2 and 3 NUCALA adverse reactions from the first 24 weeks of Trials 2 and 3

Patients aged 6 to 11 years: Adverse reaction profile similar to trials in patients aged ≥12 years.

 

Serious adverse events (SAE): One SAE occurred in >1 patient and more frequently with NUCALA than placebo: herpes zoster (2 vs 0 patients).

 

Systemic reactions: In the 3 clinical trials, NUCALA 3% and placebo 5%.

  • Manifestations included rash, flushing, pruritus, headache, and myalgia. A majority were experienced on the day of dosing.

 

Immunogenicity: Across clinical trials in patients aged ≥6 years receiving NUCALA, 6% developed anti-mepolizumab antibodies and 1 patient had neutralizing antibodies detected. The clinical relevance of anti-mepolizumab antibodies is not known.

 

NUCALA was also evaluated in a 4.5-year open-label safety and efficacy study.1

See long-term data

NUCALA is the only biologic for SEA with an open-label study up to 6.4 years2

There were no unexpected safety findings in this long-term access study of patients aged ≥6 years.†

OPEN-LABEL, LONG-TERM ACCESS STUDY: SAFETY RESULTS (%)

Open-label study safety results Open-label study safety results

Median exposure to NUCALA: 15.5 months (1-77 months)

 

Serious AEs

  • Reported in >1% of patients: worsening of asthma (3%)

 

Non-serious AEs

  • Reported in ≥10% of patients: worsening of asthma (30%), lower respiratory tract infection (11%), and headache (10%)

†Add-on NUCALA every 4 weeks 100 mg SC for patients aged ≥12 years; 40 mg SC for patients aged 6-11 years.

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

§As determined by the investigator.

||Non-serious AE population included patients who received ≥1 NUCALA dose and were required per protocol to report non-serious AEs (select non-US countries and pediatric study).

See 6.4-year, open-label
study design

AE=adverse event; SC=subcutaneous.

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