Trelegy Ellipta Adverse Reactions

Summary of the safety profile: The most frequently reported adverse reactions with TRELEGY ELLIPTA were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Tabulated summary of adverse reactions: The safety profile of TRELEGY ELLIPTA is based on three phase III clinical studies and spontaneous reporting.
The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Where adverse reaction frequencies differed between studies, the higher frequency is reported as follows.
Adverse reactions are listed by MedDRA system organ class.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 3.)


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Description of selected adverse reactions: Pneumonia: In a total of 1,810 patients with advanced COPD (mean post-bronchodilator screening FEV₁ 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving TRELEGY ELLIPTA (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%). Pneumonia which required hospitalisation occurred in 1% of patients receiving TRELEGY ELLIPTA and <1% of patients receiving budesonide/formoterol up to 24 weeks. One fatal case of pneumonia was reported in a patient who received TRELEGY ELLIPTA. In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both TRELEGY ELLIPTA and budesonide/formoterol arms was equal at 2%. The incidence of pneumonia with TRELEGY ELLIPTA is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV₁ 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for TRELEGY ELLIPTA (n=4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n=4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n=2,070). Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patient-years) receiving TRELEGY ELLIPTA, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.