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Nucala is the only anti-IL-5 with up to 4.8 years of clinical trial safety data*†¹ in severe eosinophilic asthma

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.²

Nucala: Similar safety profile to placebo in clinical trials³

The safety profile of Nucala was similar to that of the placebo in the MENSA trial3
Most common
adverse events, n (%)
Placebo
(n=191)

Nucala SC
(n=194)
Nasopharyngitis
46 (24)
33 (17)
Headache 33 (17) 39 (20)
Upper respiratory tract infection 27 (14) 24 (12)
Sinusitis
18 (9) 18 (9)
Bronchitis 18 (9) 9 (5)
Oropharyngeal pain 15 (8) 7 (4)
Injection-site reaction 6 (3) 17 (9)

Nucala has a long-term safety profile similar to placebo¹

Long-term safety data shows the low frequency of common AEs associated with Nucala treatment (N=339, n=95)1

For patients receiving long-term Nucala treatment of up to 4.8 years, the rate of SAEs was ≤10%1
On-treatment SAEs, n(%)  
Asthma
34 (10)
Pneumonia 6 (2)
Nasal polyps 4 (1)
Respiratory tract infection (RTI)
3 (0.9)
Foot fracture 3 (0.9)
Lower RTI 3 (0.9)
Osteonecrosis 2 (0.6)
Diverticulitis 2 (0.6)
Fracture 2 (0.6)
Gastroesophageal reflux disease 2 (0.6)
Hyponatraemia 2 (0.6)
Influenza
2 (0.6)
On-treatment AEs, n(%)  
Nasopharyngitis
143 (42)
Asthma 77 (23)
Bronchitis 64 (19)
Upper RTI 64 (19)
Sinusitis 62 (18)
Headache 57 (17)
Influenza 44 (13)
Back pain 42 (12)

Real-world studies confirmed the safety profile seen in clinical trials⁴

France ATU real world study (Retrospective observational study): Most frequent on treatment AEs and SAEs (n=147)4
Event SOC/PT Number of
events (%)

Total 173
AEs possibly related to mepolizumab 159
General disorders and administration site conditions 62 (39.0)
Nervous system disorders 24 (15.1)
Respiratory, thoracic and mediastinal disorders 21 (13.2)
Gastrointestinal disorders 14 (8.8)
Musculoskeletal and connective tissue disorders 10 (6.3)
Skin and subcutaneous tissue disorders 9 (5.7)
Vascular disorders 5 (3.1)
Infections and infestations 3 (1.9)
Injury, poisoning and procedural complicationsᵃ 2 (1.3)
Renal and urinary disorders 2 (1.3)
Cardiac disorders 1 (0.6)
Ear and labyrinth disorders 1 (0.6)
Eye disorders 1 (0.6)
Immune system disorders 1 (0.6)
Investigations 1 (0.6)
Pregnancy, puerperium and perinatal conditions 1 (0.6)
Reproductive system and breast disorders 1 (0.6)
SAEs possibly related to mepolizumab
14
Respiratory, thoracic and mediastinal disorders 4 (28.6)
Musculoskeletal and connective tissue disorders 3 (21.4)
General disorders and administration site conditions
2 (14.3)
Nervous system disorders 2 (14.3)
Infections and infestations 2 (14.3)
Hepatobiliary disorders
1 (7.1)
Most common drug-related AEs and SAEs possibly related to mepolizumab (n≥5%)
 
Drug ineffective
31 (17.9b)
Headache 14 (8.1b)
Asthmac
31 (7.5b)
Asthenia 12 (6.9b)

aExcluding 103 events of inappropriate schedule of product administration for 61 patients;
b% of total drug related AEs and SAEs (N=173);
cincluded exercise induced asthma, asthmatic crisis and aggravated condition.

REALITI-A real-world study: most frequent on treatment AEs and SAEs (n=368)5
Parameter Mepolizumab
(N=368)

Any on-treatment AEs, a n (%) 53 (14)
Any AE related to mepolizumab, n (%) 53 (14)
Nervous system disorders 26 (7)
General disorders and administration site conditions 12 (3)
Musculoskeletal and connective tissue disorders
9 (2)
Skin and subcutaneous tissue disorders 9 (2)
Gastrointestinal disorders 6 (2)
Ear and labyrinth disorders 3 (<1)
Investigations 3 (<1)
Respiratory, thoracic and mediastinal disorders 2 (<1)
Cardiac disorders 1 (<1)
Immune system disorders 1 (<1)
Metabolism and nutrition disorders 1 (<1)
Not coded 4 (1)
Any SAE related to mepolizumab, n (%) 2 (<1)
Hypersensitivity 1 (<1)
Pharyngeal swelling 1 (<1)
Fatal SAEs, n (%) 0
Mepo-related AEs leading to permanent mepo discontinuation, n (%) 9 (2)
Nervous system disorders 4 (1)
Gastrointestinal disorders 2 (<1)
Cardiac disorders 1 (<1)
Ear and labyrinth disorders 1 (<1)
General disorders and administration site conditions 1 (<1)
Immune system disorders 1 (<1)
Musculoskeletal and connective tissue disorders 1 (<1)
Respiratory, thoracic and mediastinal disorders 1 (<1)
Skin and subcutaneous tissue disorders 1 (<1)
Not coded 2 (<1)

aOnly data on mepolizumab- and GSK product related AES are collected during the study

Real-world studies have shown that 14% of Nucala-treated patients experienced a treatment-related AE over 1 year (n=53)5

Study limitations: These data are a prespecified interim analysis of 368 patients who completed 12 months of follow-up as of February 2019. This analysis may not reflect the results from the final dataset.

Nucala has a consistent safety profile between paediatric and adult patients⁶ ⁷

No additional adverse reactions identified with Nucala in paediatric patients aged 6–11 compared with adults (N=36)

AEs, n (%)6 Nucala
40 mg SCa
n=26
Nucala
100 mg SCb
n=10
Overall
Any AE
20 (77) 6 (60) 26 (72)
Related to study treatmentc 8 (31) 3 (30) 11 (31)
Leading to withdrawald 1 (4)
0 1 (3)
Any SAE 6 (23) 1 (10) 7 (19)
Related to study treatment 2 (8)
0 2 (6)
Fatal SAE 0 0 0
Any on-treatment AE 18 (69) 6 (60) 24 (67)
Any on-treatment serious AE 5 (19) 1 (10) 6 (17)

aPatients with baseline bodyweight <40 kg were treated with Nucala 40mg SC
bPatients with baseline bodyweight ≥40 kg were treated with Nucala 40mg SC
cAs assessed by the treating investigator.
dA second subject in the 40 mg SC group withdrew consent from the study due to experiencing a combination of AEs throughout the study.
The licensed dose of Nucala in children aged 6–11 years is 40mg SC regardless of weight.

AEs, n (%) Nucala
40 mg SC
n=16
Nucala
100 mg SC
n=10
Nucala
40/100 mg SCa
n=4
Overall
n=30
Any AE
15 (94)
8 (80) 4 (100) 27 (90)
Related to study treatmentb 4 (25) 3 (30) 1 (25) 8 (27)
Leading to withdrawal 0 0 0 0
Any SAE 4 (25) 2 (20) 1 (25) 7 (23)
Related to study treatmentb 0 0 0 0
Fatal SAE 0 0 0 0
Any on-treatment AE 15 (94) 8 (80) 4 (100) 27 (90)
Any on-treatment serious AE 4 (25) 2 (20) 1 (25) 7 (23)

aThese patients weighed less than 40 kg and received 40 mg of mepolizumab at the start of part B and were moved to the 100 mg treatment group when their weight reached 40 kg
bAny AE commencing within 4 weeks of the last dose of mepolizumab.
The licensed dose of Nucala in children aged 6–11 years is 40mg SC regardless of weight.

Explore efficacy data

Footnotes

*Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.²

The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.¹

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs. randomised controlled trials.

The recommended dose of Nucala is 100 mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6–11 years is 40 mg SC regardless of weight and available in lyophilised powder.²

AE, Adverse event; ATU, Temporary Authorization for Utilization; PT, preferred term; SAE, Serious adverse event; SC, subcutaneous; SOC, System Organ Class

References

  1. Khurana S et al. Clin Ther 2019; 41:2041–2056
  2. Nucala SmPC 2021. Available at www.medicines.ie. Last accessed March 2021
  3. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  4. Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/1399 3003.02345-2019). [Epub ahead of print]
  5. GlaxoSmithKline data on file. REF-74585
  6. Gupta A, et al. Pediatric Pulmonology 2019;54:1957–1967
  7. Gupta A, et al. J Allergy Clin Immunol 2019;144:1336–1342
  8. Leather DA et al. Adv Ther 2020; 1–21

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

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PM-IE-MPL-WCNT-200015 | March 2021