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SAFETY PROFILE
Adverse Reactions With NUCALA
In trials 1, 2 and 3, (DREAM, MENSA and SIRIUS), approximately 2% of patients receiving NUCALA withdrew from the clinical trials due to adverse events, compared with 3% of patients receiving placebo.
In the clinical trial of patients aged 6-11 years, the adverse reaction profile was similar to that observed in patients aged 12 years and older.
| Adverse Event |
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: 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: In patients aged 12 years and older, 15/260 (6%) patients treated with NUCALA developed anti-mepolizumab antibodies. The reported frequency may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentration. Neutralizing antibodies were detected in 1 patient receiving NUCALA. The clearance of NUCALA was slightly increased (20%) by anti-mepolizumab antibodies. There was no evidence of a correlation between anti-mepolizumab antibody titers and change in blood eosinophil counts. The clinical relevance of the presence of anti-mepolizumab antibodies is not known. In the clinical trial of patients aged 6 to 11 years, anti-mepolizumab antibodies were detectable in 2/35 (6%) patients during the initial short phase and none during the long phase of the trial.
Trial 1 was a 52-week dose-ranging and exacerbation trial.
| 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% |
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.
