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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
| 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
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.
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.8
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
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- Nucala SmPC 2021. Available at www.medicines.ie. Last accessed March 2023
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/1399 3003.02345-2019). [Epub ahead of print]
- Harrison T;ERS 2019;REALITI-A LB Presentation;1-16
- Gupta A, et al. Pediatric Pulmonology 2019;54:1957–1967
- Gupta A, et al. J Allergy Clin Immunol 2019;144:1336–1342
- 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.
© 2023 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.
PM-IE-MPL-WCNT-200015 | March 2023
