Budesonide/Glycopyrrolate/Formoterol for the Management of COPD in a UK Primary Care Population: Real-World Use and Early Medication Success

Figures & data

Table 1 Demographic and Clinical Characteristics for Patients with COPD Initiating BGF

	New BGF users (N=285)
Age
Median (IQR)	69.8 (62.7–77.3)
40 to < 60 yrs, n (%)	51 (17.9)
60 to < 80 yrs, n (%)	185 (64.9)
80 to < 100 yrs, n (%)	49 (17.2)
Sex	N=284
Female, n (%)	153 (53.9)
BMI	N=284
Mean (SD)	28.4 (7.3)
0 to < 18.5, underweight n (%)	18 (6.3)
18.5 to < 25, healthy weight n (%)	84 (29.6)
25 to < 30, overweight n (%)	82 (28.9)
>30, obese n (%)	100 (35.2)
Smoking status	N=284
Current, n (%)	105 (36.8)
Ex, n (%)	180 (63.2)
Index of Multiple Deprivation Decile^A	N=279
1–4, n (%)	144 (51.6)
5–7, n (%)	103 (36.9)
8–10, n (%)	32 (11.5)
Race	N=267
White, n (%)	255 (95.5)
Asian, n (%)	4 (1.5)
Mixed/Others, n (%)	8 (3.0)
Comorbidities
Active asthma (within 1 year prior to BGF initiation), n (%)	88 (30.9)
Asthma prior to 40 yrs old, n (%)	36 (12.6)
Validated COPD diagnosis, n (%)	96 (33.7)
Ischemic heart disease, n (%)	35 (12.3)
Heart failure, n (%)	27 (9.5)
Depression or anxiety, n (%)	167 (58.6)
Time since first validated COPD diagnosis, years	N=171
Median (IQR)	7.9 (4.4–11.7)
FEV1 (within 2 years prior to BGF initiation), L	N=70
Mean (SD)	1.5 (0.7)
FEV1% predicted (within 2 years prior to BGF initiation)	N=50
Mean (SD)	54.5% (22.6)
GOLD stage (2022 version)	N=50
0 <30, n (%)	6 (12.0)
30 <50, n (%)	19 (38.0)
50 <80, n (%)	15 (30.0)
80 <110, n (%)	10 (20.0)
mMRC Score (nearest and within 2 years prior to BGF initiation)	N=263
0, n (%)	8 (3.0)
1, n (%)	50 (19.0)
2+, n (%)	205 (77.9)
GOLD 2022 group^B
A, n (%)	9 (3.2)
B, n (%)	23 (8.1)
C, n (%)	49 (17.2)
D, n (%)	182 (63.9)
Missing, n (%)	22 (7.7)
CAT score (nearest and prior to BGF initiation)	N=218
Mean (SD)	21.7 (7.8)
Exacerbations
Any, n (%)	100 (35.1)
Moderate exacerbations (within a year prior to BGF initiation)
Mean (SD)	0.79 (1.5)
1+, n (%)	100 (35.1)
Complicated exacerbations (within a year prior to BGF initiation)
Exacerbations, mean (SD)	0.15 (0.53)
1+, n (%)	27 (9.5)

Notes: ^AThe Index of Multiple Deprivation is the official measure of relative deprivation for small areas in England. The IMD combines information from the seven domains (income, employment, education, health, crime, housing and service, environment) to produce an overall relative measure of deprivation. ^BCOPD groups defined as follows: A: 0 or 1 moderate or severe exacerbations (not leading to hospitalization), mMRC 0–1 and CAT <10; B: 0 or 1 moderate or severe exacerbations (not leading to hospitalization), mMRC ≥2 and CAT ≥10. C: ≥2 moderate or severe exacerbations (≥1 leading to hospitalization), mMRC 0–1 and CAT <10; D: ≥2 moderate or severe exacerbations (≥1 leading to hospitalization), mMRC ≥2 and CAT ≥10.

Abbreviations: BGF, beclometasone/glycopyrrolate/formoterol; BMI, body mass index; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in one second; GOLD, Global Obstructive Lung Disease; IQR, inter-quartile range; mMRC, modified Medical Research Council; SD, standard deviation.

Table 2 COPD Treatment and Consultation Burden for Patients with COPD Initiating Treatment with BGF

	New BGF users (N=285)
Acute OCS prescription (within a year prior to BGF
Mean (SD)	1.9 (3.7)
0, n (%)	158 (55.4)
1, n (%)	33 (11.6)
2, n (%)	20 (7.0)
3+, n (%)	74 (26.0)
Antibiotic prescription within 3 days of a LRT infection (within a year prior to BGF initiation)
Mean (SD)	0.6 (1.6)
0, n (%)	204 (71.6)
1, n (%)	44 (15.4)
2, n (%)	17 (6.0)
3+, n (%)	20 (7.0)
Daily SABA Dose (µg, within a year prior to BGF initiation)
Mean (SD)	395.7 (415.3)
0 <100, n (%)	91 (31.9)
100 <200, n (%)	28 (9.8)
200 <300, n (%)	24 (8.4)
300 <400, n (%)	20 (7.0)
400 <3000, n (%)	122 (42.8)
SABA Inhalers (within a year prior to BGF initiation)
Mean (SD)	7.1 (7.1)
0, n (%)	69 (24.2)
1–2, n (%)	39 (13.7)
3–6, n (%)	46 (16.1)
7–10, n (%)	43 (15.1)
11–15, n (%)	53 (18.6)
≥16, n(%)	35 (12.3)
COPD Primary Care Consultations (within a year prior to BGF initiation)
Mean (SD)	2.3 (1.9)
0, n (%)	26 (9.1)
1, n (%)	85 (29.8)
2–4, n (%)	143 (50.2)
5–6, n (%)	20 (7.0)
≥7, n (%)	11 (3.9)
Maintenance Treatment immediately prior to BGF initiation^A
None, n (%)	47 (16.5)
LAMA, n (%)	9 (3.2)
LABA, n (%)	1 (0.4)
LABA+LAMA, n (%)	48 (16.8)
ICS+LABA, n (%)	53 (18.6)
Free triple, separates, n (%)	81 (28.4)
Fixed triple, n (%)	32 (11.2)
Other Separate/Combinations, n (%)	14 (4.9)
Maintenance Treatment (within a year prior to BGF initiation)^B
None, n (%)	58 (20.4)
LAMA, n (%)	3 (1.1)
LABA, n (%)	1 (0.4)
LABA+LAMA, n (%)	38 (13.3)
ICS+LABA, n (%)	104 (36.5)
Free triple, separates, n (%)	67 (23.5)
Fixed triple, n (%)	92 (32.3)

Notes: ^AThe last combination of maintenance COPD treatments in the year prior to the index date, combination treatment containing separates occur on the same day (patients are only in one category). ^BAll combinations of maintenance COPD treatments in the year prior to the index date, patients receiving individual separates on the same day are classed as combinations (patients can be in multiple categories).

Abbreviations: BGF, budesonide glycopyrrolate formoterol; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; LRT, lower respiratory tract; OCS, oral corticosteroid; SABA, short-acting β₂-agonist; SD, standard deviation.

Figure 1 Subject disposition.

Abbreviations: BGF, budesonide/glycopyrrolate/formoterol; COPD, chronic obstructive pulmonary disease; Dx, diagnosis.

Figure 2 (A) Maintenance medication use, (B) number of acute OCS prescriptions, (C) number of SABA inhalers and (D) number of COPD primary care consultations among COPD patients (n=285) prior to BGF initiation.

Abbreviations: BGF, budesonide glycopyrrolate formoterol; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; OCS, oral corticosteroid; SABA, short-acting β₂-agonist; Tx, treatment.

Figure 3 Proportion of patients with no MACRE and no incidence of pneumonia 90 days post-BGF initiation.

Notes: Medication success: no major cardiac and respiratory events and no incidence of pneumonia at 90 days post-BGF initiation and claimed if the lower 95% CI for the % of patients with mediation success was ≥70%.

Abbreviations: BGF, budesonide glycopyrrolate formoterol; CI, confidence interval; COPD, chronic obstructive pulmonary disease; MACRE, major cardiac and respiratory events.

Figure 4 Average daily SABA dose (mcg) pre- and post-BGF initiation.

Abbreviations: BFG, budesonide glycopyrrolate formoterol; SABA, short-acting β₂-agonist.