ADVERSE REACTIONS IN PATIENTS WITH HES

In the 32-week clinical trial in patients with HES (300 mg of NUCALA), no additional adverse reactions were identified to those reported in severe asthma trials.

Adverse reactions with NUCALA 100 mg with ≥3% incidence and more common than placebo in subjects with asthma in first 24 weeks of Trials 2 and 3*

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In the HES trial using 300 mg of NUCALA:

  • Systemic allergic hypersensitivity reactions: none
    • Other systemic reactions: 2% (n=1) NUCALA, 0% placebo
    • Manifestation was multifocal skin reaction, which occurred on the day of dosing
  • Injection site reactions (eg, burning, itching): 7% NUCALA, 4% placebo
  • Serious adverse events: 19% NUCALA, 17% placebo; none considered drug-related by the investigator1
  • Immunogenicity: In patients receiving NUCALA, <2% (n=1) developed anti-mepolizumab antibodies and no neutralizing antibodies were detected. The clinical relevance of the presence of anti-mepolizumab antibodies is not known
  • There were no adverse events of herpes zoster in patients receiving NUCALA2

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

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

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