Introduction

Fluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroids (ICS) / ultra LABA (long-acting ?2-agonist [LABA]) combination therapy licensed for the once-daily treatment of asthma in adults and adolescents aged ≥12 years in Europe and in adults aged ≥18 years in United States.

Aim

To compare asthma symptom control among adult patients who received once-daily FF/VI 100/25 mcg versus patients who received twice-daily budesonide/formoterol (B/F) 160/4.5 mcg

Patient Profile

Adult asthma patients

• ≥18 years of age on the index date
• ≥1 pharmacy claims for FF/VI 100/25 mcg or B/F 160/4.5 mcg

Methods

• Retrospective cohort study
• The study included propensity score (PS) matched adult asthma patients initiating once-daily FF/VI 100/25 mcg with patients initiating twice-daily (B/F) 160/4.5 mcg using a US claims database 
• 51,537 were included in the B/F 160/4.5 mcg cohort

• Study duration: 12 months
• Asthma control was measured by the mean number of short-acting ?2-agonist (SABA) canisters dispensed per patient-year (PPY) during follow-up

Primary endpoint

Asthma control, as measured by the mean number of SABA canisters dispensed per patient-year (PPY)

Secondary Endpoint

• Time to first, rates of, overall and severe asthma exacerbations

Results

Asthma Control

• Mean SABA canisters dispensed PPY was significantly lower for FF/VI users compared with B/F users
• 10%  reduction in use of SABA canisters was reported in participants who received FF/VI 100/25 mcg than those who received B/F 160/4.5 mcg

B/F, budesonide/formoterol; CI, confidence interval; FF/VI, fluticasone furoate/vilanterol; PPPY, per-patient per-year.

Secondary Endpoints

 Time to first overall or severe asthma-related Exacerbation

• Time to first overall (moderate or severe) or severe asthma-related exacerbation was significantly longer in the FF/VI 100/25 mcg cohort relative to the B/F 160/4.5 mcg cohort at 3, 6, 9, and 12 months of follow-up (p < 0.05 at all-time points)

• FF/VI use resulted in 13% significantly lower risk of having an overall asthma-related exacerbation and 22% lower risk of a severe exacerbation versus B/F use

B/F, budesonide/formoterol; CI, confidence interval; FF/VI, fluticasone furoate/vilanterol

Rate of overall and severe asthma-related exacerbations

• Asthma-related exacerbation rates per 100 patient-days were a significantly lower for the FF/VI group compared with the B/F group (overall: 0.0475 vs. 0.0558, p < 0.001; severe: 0.0026 vs. 0.0033, p = 0.020)
• Initiation with FF/VI 100/25 mcg was also associated with a lower rate of overall (0.1796 vs. 0.2081) and severe (0.0097 vs. 0.0131) asthma-related exacerbations PPPY compared with initiation of B/F 160/4.5 mcg

Table 1: Overall and severe asthma-related exacerbations during follow-up in the main analysis

B/F, budesonide/formoterol; CI, confidence interval; FF/VI, fluticasone furoate/vilanterol; PPPY, per-patient per-year

Subgroup Analysis (patient with >1 prior exacerbations)

• Significantly fewer SABA canisters were used in patients with ≥1 prior exacerbation (overall or severe) who were initiated on FF/VI 100/25 mcg during the follow-up period (1.75 vs. 2.06 PPY; RR [95% CI] = 0.85 [0.78–0.92], p < 0.001)
• 15%  reduction  in use  of SABA canisters  was reported in patients with ≥1 prior exacerbation receiving FF/VI 100/25 mcg  compared to patients who received B/F 160/4.5 mcg
• Significantly longer time to first overall (moderate or severe) or severe asthma-related exacerbation was observed (p < 0.05)
• 21% lower risk of overall asthma-related exacerbations (HR [95% CI] = 0.79 [0.71–0.88], p < 0.001) and a 32% lower risk of severe asthma-related exacerbations at 12 months post-index was reported (HR [95% CI] = 0.68 [0.47–0.99], p = 0.047) than patients in the B/F 160/4.5 mcg cohort
• FF/VI 100/25 mcg was associated with a significantly lower rate of overall (RR [95% CI] = 0.80 [0.72–0.90]; p < 0.001) and severe (RR [95% CI] = 0.62 [0.42–0.98]; p = 0.028) asthma-related exacerbations per 100 patient-days compared with initiation of B/F 160/4.5 mcg
• Initiation with FF/VI 100/25 mcg was associated with a lower rate of overall (0.3361 vs 0.4103) and severe (0.0189 vs 0.0332) asthma-related exacerbations compared with initiation of B/F 160/4.5 mcg

Conclusion

The study demonstrated that in real-world practice, initiation of once-daily FF/VI 100/25 mcg in adults with asthma was associated with significantly lower use of SABA and fewer asthma-related exacerbations, which may indicate better asthma control, when compared with use of twice-daily B/F 160/4.5 mcg.

Reference

J Asthma. 2021 Aug 25:1-14. doi: 10.1080/02770903.2021.1963767.