Adverse reactions in patients with EGPA

In a 52-week clinical trial in patients with EGPA (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 
  Adverse reaction NUCALA 100 mg
  Headache 19 18  
  Injection site reaction 8 3  
  Back pain 5 4  
  Fatigue 5 4  
  Influenza 3 2  
  Urinary tract infection 3 2  
  Abdominal pain upper 3 2  
  Pruritis 3 2  
  Eczema 3 <1  
  Muscle spasms 3 <1  

In the EGPA trial using 300 mg of NUCALA:

  • Systemic reactions, including hypersensitivity reactions: Percentages of subjects who experienced systemic (allergic and nonallergic) reactions were 6% for subjects receiving 300 mg of NUCALA and 1% for placebo. Manifestations of systemic allergic reactions included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, and stridor. The reported manifestation of systemic nonallergic reactions was angioedema. Two of the four (50%) systemic reactions in subjects receiving 300 mg of NUCALA were experienced on the day of dosing
  • Injection site reactions (eg, pain, erythema, swelling) occurred in 15% of subjects treated with NUCALA versus 13% treated with placebo
  • The overall incidence of serious adverse events was lower in the group receiving NUCALA (18%) compared with placebo (26%). Incidence of serious adverse events considered drug-related by the investigator was similar between the treatment groups (4% each)1
  • Immunogenicity: In subjects with EGPA treated with 300 mg of NUCALA, 1 subject (<2%) developed anti-mepolizumab antibodies. No neutralizing antibodies were detected in any subjects with EGPA. The clinical relevance of the presence of anti-mepolizumab antibodies is not known

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