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* Special interest groups related to UMEC and LAMAs
TRELEGY Ellipta safety profile
TRELEGY Ellipta demonstrates a safety and tolerability profile consistent with that of an ICS/LABA (FF/VI)¹
The safety profile of TRELEGY Ellipta in asthma is based on a randomised, double-blind, parallel-group, active-controlled, 24–52-week trial that enrolled 2,436 adult subjects inadequately controlled on their current treatment of combination therapy (ICS plus a LABA).¹ In this study, the incidence of adverse reactions observed for the groups treated with TRELEGY Ellipta was similar to that observed for the ICS/LABA (FF/VI) arms.¹
Safety profile in asthma2,3
| On-treatment adverse events (AEs) |
ICS/LABA (FF/VI) 100/25 mcg (n=407) |
TRELEGY Ellipta (FF/UMEC/VI) 100/62.5/25 mcg (n=406) | ICS/LABA (FF/VI) 200/25 mcg (n=406) |
TRELEGY Ellipta (FF/UMEC/VI) 200/62.5/25 mcg (n=408) |
|---|---|---|---|---|
| Nasopharyngitis |
63 (15%) |
60 (15%) |
53 (13%) | 51 (13%) |
| Headache |
30 (7%) |
36 (9%) |
23 (6%) | 19 (5%) |
| Adrenal suppression | 0 | 0 | 0 | 0 |
| Hyperglycaemia/new onset diabetes mellitus (SMQ) | 12 (3%) | 14 (3%) | 8 (2%) | 8 (2%) |
| Anticholinergic syndrome (SMQ)* | 7 (2%) | 12 (3%) | 8 (2%) | 7 (2%) |
| Dry mouth/drying of airway secretions* | 1 (<1%) | 2 (<1%) | 0 |
1 (<1%) |
| Infective pneumonia (SMQ) | 7 (2%) | 5 (1%) | 7 (2%) | 4 (<1%) |
| LRTI (excluding infective pneumonia SMQ)* | 20 (5%) | 24 (6%) | 25 (6%) | 23 (6%) |
| Urinary retention* | 0 | 0 | 0 | 0 |
- Nasopharyngitis was the most common adverse event
- AEs of special interest, such as pneumonia and anticholinergic effects, were similar across TRELEGY Ellipta and ICS/LABA (FF/VI) and were consistent with class effects in asthma:
- Pneumonia incidence was 2% on ICS/LABA (FF/VI) and ≤1% on TRELEGY Ellipta
- Anticholinergic effects were similar across TRELEGY Ellipta and ICS/LABA (FF/VI) with no incidence of urinary retention and <1% incidence of LAMA-related dry mouth/drying of airway secretions for patients treated with ICS/LABA (FF/VI) or TRELEGY Ellipta
- Pneumonia incidence was 2% on ICS/LABA (FF/VI) and ≤1% on TRELEGY Ellipta
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Footnotes
AE, adverse event; FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting ß₂-adrenergic agonist; LAMA, long-acting muscarinic antagonist; LRTI, lower respiratory tract infection; SMQ, Standardised MedDRA Queries; VI, vilanterol
TRELEGY Ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a LABA and ICS.4
References
- Pavord I et al. Abstract 785. J Allergy Clin Immunol 2020; 145:AB241.
- Lee LA et al. Lancet Respir Med 2021; 9(1): 69-84
- Lee LA et. al. Lancet Respir Med 2021;9(1): 69-84. Supplementary Appendix.
- TRELEGY Ellipta Singapore Prescribing Information GDS12/IPI13a (SI).
Adverse events should be reported. For reporting of adverse events, please write to sg.drugsafety@gsk.com.
Click here for Prescribing Information:
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PM-SG-FVU-WCNT-240015 | April 2024
