Real-world evidence with extrafine single-inhaler triple therapy in asthma: the TriMaximize study

Introduction Recently, randomized controlled trials have shown significant clinical benefits of single-inhaler triple therapy consisting of extrafine beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) in the treatment of asthmatics not adequately controlled with ICS/LABA, and with ≥1 exacerbation in the last year. The TriMaximize study aims to provide a real-world evidence view of the characteristics and therapy pathways of moderate-severe asthmatics prescribed extrafine BDP/FF/G in real-world practice and to characterize the effects on health-related outcomes.

Methods This is a multicenter, multicountry, prospective non-interventional study aiming to enroll and observe 2,600 asthmatics prescribed extrafine BDP/FF/G for ≥1 year in a real-world practice. Here we report descriptive baseline characteristics of the first 260 patients from 47 German centers.

Results This interim study population consisted of 62.3% females, 32.7% former and 19.6% current smokers with an average of 19.1 and 20.9 pack years, respectively. The average age was 57.4 years, the average BMI 28.2 kg/m², the average percent predicted pre-dose FEV₁ 66%, and the average time of illness 13.6 years. Information on allergy status was available in 54.6% of patients with 76.1% diagnosed with ≥1 allergy. ≥1 concomitant disease was reported in 72.4% of patients with 20.6% having COPD. Average ACT and Mini AQLQ scores were 14.7 and 4.2, respectively, and a TAI score ≤45 was reported in 23.8% of patients. Average rate of moderate/severe asthma exacerbations in the last year was 1.7. Asthma-related healthcare resource utilization in the last 3 months was reported in 29.3% of patients. Previous treatment consisted of ICS/LABA fixed dose combination (68.1%) or multi-inhaler triple therapy (MITT, 23.1%). In 44.6% of patients, poor symptom control under previous therapy was the main reason for receiving a prescription of BDP/FF/G.

Conclusion These real-world data in 260 asthmatics in Germany display a patient population with poorly controlled asthma despite receiving ICS/LABA or MITT. The significant effect of asthma on health-related quality of life and healthcare resource utilization in this population calls for a re-evaluation of their asthma therapy with special attention to treatment intensity and adherence.

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Artikel online veröffentlicht:
11. Mai 2022