INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

Abstract

IntroductionReal-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) and MITT were compared in usual clinical care.MethodsINTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary end-point was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at week 24. Secondary end-points in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making at least one critical error in inhalation technique at week 24. Safety was also assessed.Results3092 patients were included (FF/UMEC/VI n=1545; MITT n=1547). The proportion of CAT responders at week 24 was significantly greater with FF/UMEC/VI versus non-ELLIPTA MITT (OR 1.31, 95% CI 1.13–1.51; p<0.001) and mean change from baseline in FEV1 was significantly greater with FF/UMEC/VI (77 mL versus 28 mL; treatment difference 50 mL, 95% CI 26–73 mL; p<0.001). The percentage of patients with at least one critical error in inhalation technique was low in both groups (FF/UMEC/VI 6%; non-ELLIPTA MITT 3%). Safety profiles, including incidence of pneumonia serious adverse events, were similar between treatments.ConclusionsIn a usual clinical care setting, treatment with once-daily single-inhaler FF/UMEC/VI resulted in significantly more patients gaining health status improvement and greater lung function improvement versus non-ELLIPTA MITT.

Characteristics of New Users of Single- and Multiple-Inhaler Triple Therapy for COPD in Primary Care in England

“… 9 , 10 In addition, the INTREPID study recently demonstrated that patients treated with FF/UMEC/VI had a higher likelihood of achieving a clinically relevant improvement in health status, as assessed by the COPD Assessment Test, than those treated with MITT. 11 …”

Disease Burden and Healthcare Utilization Among Patients with Chronic Obstructive Pulmonary Disease (COPD) in England

“…[30][31][32][33][34][35][36][37] In particular, significantly more patients in the INTREPID trial who were treated with FF/UMEC/VI achieved health status improvement compared to those receiving non-ELLIPTA MITT. 38 These improvements could be attributed to improved adherence with SITT, and a resultant lack of missed doses that is associated with the use of multiple inhalers. Patients with moderate to severe COPD who require triple therapy may therefore benefit from switching to SITT, which has the potential to improve both https://doi.org/10.2147/COPD.S336158…”

“…International Journal of Chronic Obstructive Pulmonary Disease 2022:17 422 adherence and outcomes. [38][39][40] Indeed, in a recent study carried out in the USA, patients with COPD initiating FF/UMEC/VI were found to have better adherence than those initiating MITT. 14 A recent study using an economic model estimated that increased use of SITT in patients with moderate to severe COPD would be associated with improved adherence, decreased exacerbation and mortality rates, and healthcare cost savings.…”

European Respiratory Society International Congress 2021: Highlights from the Respiratory clinical care and physiology assembly

“…In another work by K endall et al [ 41 ] using data from the INTREPID trial [ 42 ] and UK cost data, single-inhaler triple therapy with fluticasone, umeclidinium and vilanterol was found to be cost-effective and cost-saving in several estimated scenarios compared to non-Ellipta multiple-inhaler triple therapy.…”