EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS

Advances in Therapy, vol. 40, pp. 3263–3278

Abstract

The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β 2 -agonist (LABA) plus inhaled corticosteroid (ICS) combination for the treatment of chronic obstructive pulmonary disease (COPD). In patients treated with LABA/ICS, who continue to experience symptoms without frequent or severe exacerbations, GOLD now recommends switching to long-acting muscarinic antagonist (LAMA)/LABA instead of escalating to triple therapy (TT; LAMA/LABA/ICS), which previously was also a recommended option. EVELUT ® , a real-life, observational study, compared these two treatment strategies in terms of symptom relief and health status improvement. Patients with symptomatic COPD at low exacerbation risk (GOLD B) were switched, at their physicians’ discretion, from LABA/ICS to either fixed-dose LAMA/LABA (tiotropium/olodaterol, Respimat ® [Tio/Olo]) or fixed or free TT. Primary endpoints were change in modified Medical Research Council (mMRC) and COPD Assessment Test™ (CAT™) scores after 12 weeks. The safety set contained 463 patients (Tio/Olo, n = 329; TT, n = 134). In a propensity score-matched set (Tio/Olo, n = 121; TT, n = 121), improvement in mMRC score was similar in patients on Tio/Olo (–0.23; 95% confidence interval [CI] –0.11, –0.36) and TT (–0.25; 95% CI –0.13, –0.38). Improvement in total CAT score was slightly larger in patients on Tio/Olo (–3.45; 95% CI –2.45, –4.45) versus TT (–2.51; 95% CI –1.62, –3.40). In both groups, Physician’s Global Evaluation scores increased, with 69–89% of patients satisfied with their treatment overall. Marginally more patients on Tio/Olo responded to treatment versus TT (Δ mMRC score ≥ 1; 25% vs. 22%; Δ CAT score ≥ 2, 68% vs. 56%). In patients with symptomatic COPD at low exacerbation risk, treatment can be switched from LABA/ICS to LAMA/LABA without compromising clinical benefit, compared with escalating to LAMA/LABA/ICS. Switching from LABA/ICS to LAMA/LABA can provide symptom relief and improve health status without exposure to the risks associated with ICS. ClinicalTrials.gov: NCT03954132.

Authors 6

1. Roland Buhl corresponding

   University Medical Center of the Johannes Gutenberg University Mainz

   Affiliation as printed

   Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, 55131, Mainz, Germany. roland.buhl@gmail.com

   Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, 55131, Mainz, Germany

2. Michael Dreher Aachen Department of Pneumology and Intensive Care Medicine

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Aachen, Germany

3. Muriel Mattiucci-Guehlke

   Boehringer Ingelheim (Germany)

   Affiliation as printed

   HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany

4. Rachel Emerson-Stadler

   Boehringer Ingelheim (Germany)

   Affiliation as printed

   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

5. Christian Taube

   Ruhrlandklinik · Essen University Hospital · University of Duisburg-Essen

   Affiliation as printed

   Department of Pulmonary Medicine, University Hospital Essen, Ruhrlandklinik, University Duisburg-Essen, Essen, Germany

6. Claus Franz Vogelmeier

   Universitätsklinikum Gießen und Marburg · German Center for Lung Research

   Affiliation as printed

   Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Gießen and Marburg, German Center for Lung Research (DZL), Marburg, Germany