Trelegy Ellipta Adverse Reactions

Adverse Reaction Overview: The overall safety profile of TRELEGY ELLIPTA was generally consistent with the known pharmacologic class effects of ICSs, LAMAs and/or LABAs. In trials in adult subjects with COPD or asthma, the most common adverse reaction was nasopharyngitis (see Clinical Trial Adverse Reactions as follows).
Clinical Trial Adverse Reactions: Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Clinical Trial Adverse Reactions in Subjects with COPD: The safety profile of TRELEGY ELLIPTA (ICS/LAMA/LABA) in subjects with COPD is based on data from two phase III clinical studies (CTT116853 and CTT116855).
Study CTT116853 included 911 patients with COPD who received TRELEGY ELLIPTA 100/62.5/25 mcg once daily for up to 24 weeks, of whom 210 patients received TRELEGY ELLIPTA 100/62.5/25 mcg once daily for up to 52 weeks, during a phase III clinical study versus an active comparator (ICS/LABA) administered twice daily (see Table 6).
Study CTT116855 included 4,151 patients with COPD who received TRELEGY ELLIPTA 100/62.5/25 mcg once daily for up to 52 weeks during a phase III clinical study versus one of two active comparators (ICS/LABA or LAMA/LABA) (see Table 7).
Adverse reactions detected during these clinical trials are listed by MedDRA system organ class.

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Pneumonia: In study CTT116853, 1,810 patients with COPD with mean post-bronchodilator screening FEV₁ 45% of predicted, standard deviation [SD] 13%, and a history of exacerbations were treated with TRELEGY ELLIPTA 100/62.5/25 mcg or an active comparator (ICS/LABA). There was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving TRELEGY ELLIPTA 100/62.5/25 mcg (2%) than in patients receiving ICS/LABA (<1%). Pneumonia which required hospitalization occurred in 1% of patients receiving TRELEGY ELLIPTA 100/62.5/25 mcg and <1% of patients receiving ICS/LABA up to 24 weeks. One fatal case of pneumonia was reported in a patient who received TRELEGY ELLIPTA 100/62.5/25 mcg. In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both TRELEGY ELLIPTA 100/62.5/25 mcg and the ICS/LABA arms was equal at 2%.
In study CTT116855, 10,355 patients with COPD with mean post-bronchodilator screening FEV₁ 46% of predicted, SD 15%, and a history of 1 or more moderate or severe exacerbations within the prior 12 months were treated with TRELEGY ELLIPTA 100/62.5/25 mcg or one of two active comparators (ICS/LABA or LAMA/LABA) up to 52 weeks. The incidence of pneumonia (adverse events of special interest) was 8% for TRELEGY ELLIPTA 100/62.5/25 mcg, 7% for ICS/LABA, and 5% for LAMA/LABA. Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patient-years) receiving TRELEGY ELLIPTA 100/62.5/25 mcg, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving ICS/LABA, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving LAMA/LABA.
Clinical Trial Adverse Reactions in Subjects with Asthma: The safety profile of TRELEGY ELLIPTA (ICS/LAMA/LABA) in adult subjects with asthma is based on one Phase III clinical study (205715) with a variable treatment duration of 24 to 52 weeks.
Study 205715 included 814 adult subjects with asthma who received TRELEGY ELLIPTA 100/62.5/25 mcg or 200/62.5/25 mcg once daily for up to 52 weeks versus an active comparator (fluticasone furoate/vilanterol) administered once daily (see Table 8). Adverse reactions observed for the groups treated with TRELEGY ELLIPTA were similar to those observed for the fluticasone furoate/vilanterol arms.
Adverse reactions detected during study 205715 are listed by MedDRA system organ class. (See Table 8.)

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Pneumonia: The incidence of pneumonia events requiring hospitalisation was similar in the TRELEGY ELLIPTA and fluticasone furoate/vilanterol groups (<1% for all groups). There were no fatal pneumonia events.
Less Common Clinical Trial Adverse Reactions: COPD: In addition to adverse reactions reported in Table 6 and Table 7, adverse reactions occurring at a rate of less than 1% in subjects with COPD receiving TRELEGY ELLIPTA included: Cardiac disorders: supraventricular tachyarrhythmias, tachycardia, atrial fibrillation.
Gastrointestinal Disorders: dry mouth.
Infections and infestations: oropharyngeal candidiasis.
Musculoskeletal and connective tissue disorders: fractures.
Respiratory, thoracic, and mediastinal disorders: dysphonia.
Asthma: In addition to adverse reactions reported in Table 8, adverse reactions occurring at a rate of less than 1% in subjects with asthma receiving TRELEGY ELLIPTA included: Cardiac disorders: supraventricular tachyarrhythmias, tachycardia, atrial fibrillation.
Gastrointestinal disorders: constipation, dry mouth.
Infections and infestations: candidiasis of mouth and throat.
Musculoskeletal and connective: arthralgia, fractures.
Nervous system disorders: dysgeusia.
Post-Market Adverse Reactions: The following relevant adverse reactions have been identified from post-approval use of TRELEGY ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions including anaphylaxis, angioedema, urticaria and rash.
Eye Disorders: vision blurred, glaucoma, eye pain.
Renal and Urinary Disorders: urinary retention, dysuria.