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- Well tolerated safety profile
- Consistent across multiple real-life and clinical trials
Nucala is the only biologic in T2 Severe Asthma with up to 10 years of clinical trial safety data 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
The only biologic in Severe Asthma T2* with safety data up to 10 years1.
A Phase 3b, open-label, multicenter, extension, long-term safety study in pediatric and adult patients with severe T2* asthma who previously participated in studies and clinical trials with NUCALA (COLUMBA, SIRIUS, COSMEX, MUSCA, OSMO).
No new safety signals with NUCALA during the extended follow-up period up to ~10 years.
| Long-term safety data for NUCALA: up to 10 years.1 | |
|---|---|
| Serious Adverse Effects (N=514): | n (%) |
| Any during/after treatment | 38 (<7) |
| Related to treatment | 2 (<1) |
| Which led to permanent discontinuation of treatment | 3 (<1) |
| Most Common Serious AEs During Treatment: | |
| Asthma | 13 (3) |
| Pneumonia | 3 (<1) |
| Non-Serious Adverse Effects (N=88) | n (%) |
| Any during/after treatment | 52 (59) |
| Related to treatment | 6 (7) |
| Which led to permanent discontinuation of treatment: | 1 (1) |
| Most Common Non-Serious AEs During Treatment: | |
| Asthma | 26 (30) |
| Lower respiratory tract infections | 10 (11) |
| Headache | 9 (10) |
| 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
REALITI-A Study
Only investigator-determined treatment-related AEs were reported (Table 8).6 During the 0–12 months post-exposure period, 18 (2%) patients experienced drug-related AEs that led to discontinuation of treatment. No additional drug-related AE was reported that led to perm
| Treatment-relateda AEs | n (%) |
| Any on-treatment AEs | 90 (11) |
| Leading to discontinuation of mepolizumab 100 mg SC | 18 (2) |
| Leading to study withdrawalb | 11 (1) |
| Treatment-related AEs reported by ≥ 5 patients, | n (%) |
| Headache | 33 (4) |
| Pruritus | 6 (< 1) |
| Fatigue | 6 (< 1) |
| Influenza like illness | 5 (< 1) |
| Nausea | 5 (< 1) |
| Arthralgia | 5 (< 1) |
| Treatment-related SAEs | n (%) |
| Any on-treatment SAEs | 7 (< 1) |
| Fatal SAEs 1 (< 1)c |
Adapted by GSK from Caruso C, et al. CHEST Pulm. 2024
a As determined by the Investigator; only AEs related to mepolizumab 100 mg SC were collected; b All AEs leading to withdrawal from the study also led to discontinuation of treatment with mepolizumab; c One patient had a fatal SAE (diffuse liver malignancy) that was considered related to treatment with mepolizumab by the Investigator.
AE = adverse event; SAE = serious adverse event; SC = subcutaneous. anent discontinuation of treatment in the second year of the study.18
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. Available at medicines.ie last accessed Jun 2025
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Caruso, Cristiano, et al. "Prospective REALITI-A Study: 2-Year Real-World Benefits of Mepolizumab in Severe Asthma." CHEST Pulmonary 3.1 (2025): 100107.
- 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
- Taillé C et al. Eur Respir J 2020
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie.
Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 or via online form https://gsk.public.reportum.com/.
GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.
POM. Further information is available from GlaxoSmithKline (Ireland) Ltd
PM-IE-MPL-WCNT-200015 | June 2025
