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Safety profile of Nucala in patients with SEA
Nucala: well-tolerated by patients, with up to 4.8 years of safety data in SEA.*†1
Safety profile of Nucala in clinical trials3
| 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) |
The most common adverse events were those that were reported in ≥ 5% of the patients in any study group.3
Nucala has a long-term safety profile consistent with previous mepolizumab clinical studies1
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 AE occuring in > 10% of the patients and on-treatment SAE occuring in > 1 patient.1
| 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 EVIDENCE SAFETY DATA
Real-world studies confirmed the safety profile seen in clinical trials4
REALITI-A real-world study: most frequent on treatment AEs and SAEs (n=368)5
| Parameter | 1 year5 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
On treatment is defined as first mepolizumab dose ≤ AE onset date & time ≤ last mepolizumab dose + 28 days.
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.
REAL LIFE DATA BELGIUM most frequent on treatment AEs and SAEs (n=116)9
SAFETY POPULATION (N =116)9
The main AE reported was headache (40%), mainly during the first 2 days after injection. Fatigue was observed in 30% nasopharyngitis, in 8%, arthralgia in 5% and myalgia in 3% of the treated patients.9
NUCALA PAEDIATRIC SAFETY DATA
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)
Study 200363 was an open-label, single-arm, multi-centre, two-part Phase II study conducted in children 6-11 years of age with severe eosinophilic asthma. Part A focused on PK/PD of mepolizumab SC assessed over 12 weeks on treatment with an 8-weeks follow-up. Part B focused on long-term safety and PD. Children who completed all treatments and assessments in Part A were eligible to enter Part B: participation was optional.6,7
| AEs, n (%)6 | Nucala 40 mg SCa n=26 |
Nucala 100 mg SCb n=10 |
Overall n=36 |
| 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 treatmentc | 2 (8) |
0 | 2 (6) |
| Fatal SAE | 0 | 0 | 0 |
| Any on-treatment AEe | 18 (69) | 6 (60) | 24 (67) |
| Any on-treatmente serious AE | 5 (19) | 1 (10) | 6 (17) |
aPatients with baseline bodyweight <40 kg were treated with Nucala 40mg SC6 Indicated Nucala dose for children aged 6–11 years is 40mg SC once every 4 weeks, regardless of weight.2
bPatients with baseline bodyweight ≥40 kg were treated with Nucala 100 mg SC6 Indicated Nucala dose for children aged 6–11 years is 40mg SC once every 4 weeks, regardless of weight.2
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.2
eFrom the first mepolizumab dose to 4 wk of the last mepolizumab dose.
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Footnotes
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 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 once every 4 weeks regardless of weight and available in lyophilised powder or in a pre-filled syringe.2
Abbreviations:
AE, Adverse event; ATU, Temporary Authorization for Utilization; IL-5, interleukin 5; IV, intravenous; mepo, mepolizumab; OCS, oral corticosteroid; PD, pharmacodynamics; PK, pharmacokinetics; PT, preferred term; RTI, respiratory tract infection; SAE, Serious adverse event; SC, subcutaneous; SOC, System Organ Class
References
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- Nucala preparatomtale
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Taillé C et al. Eur Respir J 2020;55:1-39
- Harrison T et al. Eur Respir J, 2020;56;1-14
- Gupta A, et al. Pediatr Pulmonol 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
- Schleich F. et al.Clin Exp Allergy 2020:;50; 687-695.
Nucala is a trademark of the GSK group of companies
PM-NO-MPL-WCNT-230010 June 2023
