FF/VI met primary and secondary endpoints in increasing the mean proportion of days covered and time to index treatment discontinuation.
Patients initiating treatment for asthma with once-daily fluticasone furoate/vilanterol (FF/VI) (Breo Ellipta, GlaxoSmithKline) had higher medication adherence and were less likely to discontinue therapy compared with patients initiating either twice-daily budesonide/formoterol (B/F) or fluticasone propionate/salmeterol (FP/SAL), according to new results presented in a poster at the American College of Allergy, Asthma and Immunology in Seattle, Washington.
To arrive at their results, investigators led by Carlyne Avarelle, MS, SM conducted a retrospective cohort study that pulled eligible participants and data from the IQVIA Real-World Data Adjudicated Claims—US database. From the database, a total of 3,972 FF/VI, 29,661 B/F and 26,745 FP/SAL users met study criteria. Then, 3,764 and 3,339 FF/VI users were matched to B/F (N=3,764) and FP/SAL (N=3,339) users, respectively.
The primary endpoint was the mean proportion of days covered (PDC), which equaled the total days covered by index medication in the follow-up period, divided by the total days in follow-up. Investigators found that the mean PDC was significantly higher for patients taking FF/VI compared to B/F (FF/VI: 0.453; B/F: 0.345; adjusted P <.001).
The secondary endpoint was the proportion of patients achieving PDC ³0.5 and PDC ³0.8, and the time to index treatment discontinuation (>45 days dispensing gap). The percentage of patients who achieved PDC ³0.5 and PDC ³0.8 were also significantly higher for FF/VI than for B/F and FP/SAL groups (P < .001).
Moreover, the risk of treatment discontinuation was 30% lower for FF/VI versus B/F users (adjusted HR: 0.70 [95% CI=0.66-0.74], P < .001) and 27% lower for FP/SAL (adjusted HR 0.73 [95% CI=0.68-0.77], P < .001).
Overall, asthma patients initiating once-daily FF/VI had higher adherence and were less likely to discontinue therapy compared with patients initiating either twice-daily B/F or FP/SAL.
However, the study did have 2 key limitations. First, investigators used claims data, and thus, indirect measures of adherences that were not prospectively assessed. Because the PDC was derived from pharmacy dispensing data, it was unclear whether patients actually used the medication. Second, since this was an observational study, residual confounding not addressed by matching or statistical models could still be apparent, so any outcome attributable to treatment is by association only.
Despite the study’s limitations, Dr Sanjeev Khindri, a physician instrumental in pushing the Arnuity Ellipta brand of the therapy to its approval for pediatric asthma maintenance by the US Food and Drug Administration (FDA) in May 2018 during the American Thoracic Society’s annual meeting, said the therapy marks a major clinical development for pediatric asthma patients.
“It is critically important we provide prescribers and their patients/parents with a choice of effective and safe medicines that have been evaluated in appropriate and robust clinical trials. The approval of Arnuity Ellipta 50 mcg for children aged 5-12 based on the clinical study package discussed above provides a safe and effective medicine delivered in an easy to use once-daily device.
FF/VI is for adult patients with asthma uncontrolled on a long-term control medication like inhaled corticosteroids (ICS), or whose disease warrants and ICS/long-acting beta2-adrengergic agonist (LABA).