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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 EVENTS ≥3% (AND MORE COMMON THAN PLACEBO) IN THE FIRST 24 WEEKS OF TRIALS 2 AND 3
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.

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

COLUMBA (4.5-year open-label study)1,2

MOST FREQUENT ADVERSE EVENTS (≥10%)
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.

REFERENCES:

  1. Data on file, GSK.
  2. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.