Pneumologie 2021; 75(S 01): S12-S13
DOI: 10.1055/s-0041-1723286
Latebreaking Abstracts 2021

COPD exacerbation benefits relative to pneumonia risk with budesonide/glycopyrronium/formoterol metered dose inhaler: analyses from ETHOS

K F Rabe
1   Lungenclinic Grosshansdorf Gmbh; Zentrum Für Pneumologie Und Thoraxchirurgie; Airway Research Center North (Arcn), Deutsches Zentrum für Lungenforschung (DZL)
,
F J Martinez
2   New York
,
G T Ferguson
3   Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA
,
D Singh
4   Medicines Evaluation Unit Ltd; University of Manchester
,
J Wedzicha
5   Nationales Herz- und Lungeninstitut, Imperial College London
,
M Jenkins
6   AstraZeneca
,
M Aurivillius
6   AstraZeneca
,
C Reisner
6   AstraZeneca
,
P Dorinsky
6   AstraZeneca
› Author Affiliations
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Background: In the Phase III, 52-week ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) fixed-dose combination significantly reduced exacerbations vs. dual therapies. However, use of inhaled corticosteroids (ICS) may also increase pneumonia risk.

Objective: To quantify exacerbation benefits relative to pneumonia risk (expressed as numbers needed to treat [NNT] and numbers needed to harm [NNH], respectively) in ETHOS.

Methods: Patients with moderate-to-very severe COPD and ≥ 1 moderate/severe exacerbation in the prior year received BGF MDI 320/14.4/10 µg or 160/14.4/10 µg, glycopyrronium/formoterol (GFF) MDI 14.4/10 µg or budesonide/formoterol (BFF) MDI 320/10 µg twice-daily via a single Aerosphere inhaler. Exacerbation and pneumonia rates were used to calculate NNT and NNH.

Results: BGF MDI 320 µg reduced exacerbation rates vs. GFF MDI (NNT = 3 [95% CI 3, 5]) and vs. BFF MDI (NNT = 7 [95% CI 4, 18]), (mITT, n = 8509). Pneumonia rates across treatments were 0.02 – 0.05 per patient year, and were lower for BGF MDI than BFF MDI; for BGF MDI 320 µg vs. GFF MDI, NNH = 58 (95% CI 29, 152) ([Table 1]).
Conclusions: In patients with moderate/very severe COPD, BGF MDI 320 µg reduced exacerbation risk vs. both dual therapies. For the ICS component, the NNH (BGF MDI 320 µg vs. GFF MDI) suggests a low pneumonia risk for BGF MDI relative to its benefits on exacerbations.

Tab. 1 Model-adjusted rates of exacerbations, pneumonia and associated NNT and NNH values for the mITT population.

BGF MDI
320/14.4/10 µg
(N = 2137)

BGF MDI
160/14.4/10 µg
(N = 2121)

GFF MDI
14.4/10 µg
(N = 2120)

BFF MDI
320/10 µg
(N = 2131)

Model-adjusted rates of moderate/severe exacerbations per year

1.08

1.07

1.42

1.24

Model-adjusted rates of confirmed pneumonia per year

0.04

0.03

0.02

0.05

NNT moderate/severe exacerbations (95% CI)

BGF 320/14.4/10 µg vs. comparator

–

–

3 (3, 5)

7 (4, 18)

NHH confirmed pneumonia (95% CI)

BGF MDI 320/14.4/10 µg vs. comparator

–

–

58 (29, 152)

N/Aa



Publication History

Article published online:
30 April 2021

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