Biological Anti-IL-5/IL-5R Therapeutics for Chronic Obstructive Pulmonary Disease (COPD) with Specific Treatable Traits: A Real-World Retrospective Analysis

Figures & data

Table 1 Patient Characteristics 8 Months ± 2 Days Prior to Initiation of Treatment (n=17 Unless Otherwise Specified)

	Mean ± SD /n (%)
Socio-demographics
Age, in year	67.8 ± 11.5
Gender: Male gender	10 (59%)
BMI	26.5 ± 4.9
Smoking Status
Never smoker	1 (6%)
Current smokers	4 (23%)
Former smokers	12 (71%)
Pack-years (n=13)	40.5 ± 20.1
Severity of Airflow Obstruction by Spirometry
FEV1 (L)	1.0 ± 0.6
FEV1 (% Predicted)	37.8 ± 18.2
Severity of Airflow Obstruction by GOLD Classification
GOLD 4	8 (47%)
GOLD 3	4 (24%)
GOLD 2	5 (29%)
GOLD 1	0 (0%)
Symptoms and Health status
MRC Score	3.8 ± 0.8
CAT Score (n=7)	24.9 ± 7.7
Exacerbation Events
≥1 moderate or severe exacerbation, n (%)	17 (100%)
≥2 moderate or severe exacerbation, n (%)	14 (82%)
≥1 severe exacerbation, n (%)	14 (82%)
Respiratory Medication
Triple Therapy: ICS/LABA/LAMA	17 (100%)
Peripheral Blood Eosinophil Count (Highest in Previous Year)
200–250 cells/uL	0 (0%)
251–300 cells/uL	5 (29%)
≥300 cells/uL	12 (71%)
Peripheral Blood Eosinophil Count (Highest in Previous 5 Years)
200–250 cells/uL	0 (0%)
251–300 cells/uL	2 (12%)
≥300 cells/uL	15 (88%)
History of Asthma Prior to Smoking
Yes	1 (6%)
Comorbidities
Total number	3.2 ± 1.6
1–2 comorbidities	3 (18%)
3+ comorbidities	14 (82%)

Abbreviations: SD, Standard Deviation; BMI, Body Mass Index; FEV₁, Forced Expiratory Volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; MRC, Medical Research Council Dyspnea Scale; CAT, Chronic Obstructive Pulmonary Disease (COPD) Assessment Test; ICS, Inhaled Corticosteroid; LABA, Long-Acting β₂-Agonist; LAMA, Long-Acting Muscarinic Antagonist.

Table 2 Comparison of the Primary Outcome Exacerbations, and Secondary Outcomes Lung Function, and Symptom Burden at Baseline (Pre) and During Anti-IL-5 Therapy (Post) (n=17 Unless Otherwise Specified)

Exacerbations: 8 Months ±2 Days (n=17)	Pre	Post	Pre vs Post: Proportion Difference/RR (95% CI)^†	P-value
≥1 moderate or severe exacerbation, n (%)^#	17 (100%)	9 (52%)	47.1% (23.3%, 70.8%)	0.003*
≥2 moderate or severe exacerbation, n (%)^&	14 (82%)	3 (18%)	64.7% (36.7%, 92.7%)	<0.001*
≥1 severe exacerbation, n (%)^&	14 (82%)	6 (35%)	47.1% (23.3%, 70.8%)	0.001*
Moderate or severe exacerbation rate, (no./patient-year)^$	4.06	1.15	3.54 (2.02, 6.20)	<0.001*
Exacerbations: 12 months (n=13)	Pre	Post	Pre vs post: Risk difference/RR (95% CI)^†	P-value
≥1 moderate or severe exacerbation, n (%)^#	13 (100%)	8 (62%)	38.5% (12.0%, 64.9%)	0.039*
≥2 moderate or severe exacerbation, n (%)^#	13 (100%)	6 (46%)	53.9% (26.8%, 81.0%)	0.005*
≥1 severe exacerbation, n (%)^&	10 (77%)	5 (39%)	38.5% (12.0%, 64.9%)	0.004*
Moderate or severe exacerbation rate, (no./patient-year)^$	3.54	1.46	2.42 (1.31, 4.48)	0.005*
Lung Function and Symptom Burden: 8 months	Pre	Post	Pre vs post: β (95% CI)^‡	P-value
FEV1 (L), mean ± SD	1.0 ± 0.6	0.8 ± 0.4	0.23 (−0.02, 0.48)	0.072
FEV1 (% predicted), mean ±SD	37.8 ± 18.2	32.5 ± 14.5	5.29 (2.05, 8.54)	0.001*
CAT Score, mean ± SD	24.9 ± 7.7 (n=7)	20.6 ± 5.9 (n=9)	5.72 (1.01, 10.44)	0.017*

Notes: *Statistically significant with p<0.05. ^†RR=exacerbation rate ratio. ^#Risk difference and 95% CI estimated using method suggested by Newcombe was used for the proportion with 100%. ^&Risk difference and 95% CI was obtained by performing GEE model with binormal distribution and an identity link function for binary variables, accounting for the correlation between pre-post measures. ^$RR and 95% CI was obtained by performing GEE model with Poisson regression, accounting for the correlation between pre-post measures. ^‡β and 95% CI was obtained by performing GEE model with normal distribution, accounting for the correlation between pre-post measures.

Abbreviations: FEV1, Forced Expiratory Volume in 1 second; CAT, Chronic Obstructive Pulmonary Disease (COPD) Assessment Test.