The NUCALA safety profile is well established

The safety of NUCALA was evaluated in numerous studies, including a 4.5-year open-label study.

Adverse reactions with NUCALA

In Trial 1, Trial 2, and Trial 3, approximately 2% of patients receiving NUCALA vs 3% receiving placebo withdrew due to adverse events.

 

The adverse reaction profile for patients aged 6 to 11 years was similar to that observed in patients aged ≥12 years.

 

Adverse reactions ≥3% (and more common than placebo) in the first 24 weeks of Trials 2 and 3
Adverse reaction
 NUCALA (n=263)
 Placebo (n=257)
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%
Pruritus
 3%
 2%
Eczema
 3%
 <1%
Muscle spasms
 3%
 <1%

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, the percentages of subjects who experienced systemic (allergic and nonallergic) reactions were 3% for NUCALA and 5% for placebo. Manifestations included rash, flushing, pruritus, headache, and myalgia. A majority of the systemic reactions 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.

4.5-year safety profile of NUCALA similar to controlled asthma trials

4.5-year open-label study

MOST FREQUENT ADVERSE EVENTS (≥10%)1
Adverse Event
 Total Patients (N=347)
Viral upper respiratory tract infection
 49%
Headache
 29%
Asthma*
 27%
Upper respiratory tract infection
 23%
Bronchitis
 21%
Back pain
 18%
Arthralgia
 17%
Sinusitis
 16%
Influenza
 13%
Injection site reaction
 12%
Pain in extremity
 12%
Respiratory tract infection
 11%
Rhinitis allergic
 10%
Hypertension
 10%

Over 4.5 years2:

No neutralizing antibodies were observed

Immunogenicity (n=346): Anti-drug antibody positive 8%, neutralizing antibody positive 0. The clinical relevance of the presence of anti-mepolizumab antibodies is unknown.

Serious adverse events (≥1%): Asthma* 10%, pneumonia 2%.

Drug-related adverse events† (≥3%): Injection site reaction 12%, headache 4%.

Systemic reactions, 3%: Allergic/hypersensitivity 2%, non-allergic <1%, anaphylaxis (drug-related), 0.

Herpes zoster: 8 patients experienced events of herpes zoster; 1 event reported as a serious adverse event.

*Worsening or exacerbation of asthma.
†Based on investigator's judgement of causality.

 

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