Introduction
Methods
Subjects
Evaluation of the response to mepolizumab
Statistical analysis
Results
Assessment of all patients
all patients | ECRS (+) group | ECRS (−) group | p value between two groups | |
---|---|---|---|---|
n = 27 | n = 16 | n = 11 | ||
gender (male), n (%) | 8 (30) | 5 (31) | 3 (27) | 0.99 < a |
age (year-old), (range) | 56.3 (11.8), (35–79) | 54.2 (11.3), (35–71) | 59.3 (12.5), (36–79) | 0.31b |
duration of asthma (year), (range) | 19.6 (11.9), (4–43) | 23.5 (10.6), (8–43) | 45.4 (22.6), (4–39) | 0.020b |
BMI(kg/m2) | 22.8 (4.7) | 22.1 (4.5) | 23.9 (4.9) | 0.26b |
smoking (never / former / current), n | 20 / 7 / 0 | 12 / 4 / 0 | 8 / 3 / 0 | 0.99 < a |
atopic / non atopic, n | 21 / 6 | 15 / 1 | 6 / 5 | 0.027a |
previous omalizumab, n (%) | 8 (30) | 6 (38) | 2 (18) | 0.40a |
initial treatments use | ||||
—ICS/LABA, n(%) | 27 (100) | 16 (100) | 11 (100) | NA |
—ICS dose(μg)c, mean (SD) | 963 (222) | 950 (137) | 982 (316) | 0.60 |
—LAMA, n(%) | 13 (48) | 5 (31) | 8 (73) | 0.054 |
—LTRA, n(%) | 23 (85) | 13 (81) | 10 (91) | 0.62 |
—xanthine derivative, n(%) | 17 (63) | 9 (56) | 8 (73) | 0.45 |
—maintenance therapy of OCS, n (%) | 16 (59) | 10 (63) | 6 (55) | 0.71a |
—daily dose of OCS (mg)d, (range) | 8.4 (5.6), (0.5–20) | 7.0 (4.8), (0.5–15) | 10.8 (6.5), (5–20) | 0.29b |
comorbidities, n (%) | ||||
—ECRS | 16 (59) | 16 (100) | – | NA |
—eosinophilic otitis media | 9 (33) | 9 (56) | 0 (0) | NA |
—EGPA | 4 (15) | 4 (25) | 0 (0) | NA |
number of injection, median (range) | 9 (2–17) | 9.5 (4–17) | 7 (2–12) | 0.17b |
duration of observation (month), median (range) | 11 (4–17) | 12.5 (6–17) | 10 (4–12) | 0.014b |
all patients, n = 27 | ECRS (+) group, n = 16 | ECRS (−) group, n = 11 | between two groups | |||||||
---|---|---|---|---|---|---|---|---|---|---|
baseline | last follow-up | p valuea | at baseline | at last follow-up | p valuea | at baseline | at last follow-up | p valuea | p value‡ | |
blood eosinophil count(/mm3) | 873 (1851) | 71 (64) | < 0.0001 | 1219 (2353) | 89 (74) | 0.0004 | 338 (364) | 44 (31) | 0.005 | 0.0049 |
serum IgE (IU/ml) | 485 (713) | 305 (583) | 0.016 | 440 (415) | 261 (263) | 0.0052 | 505 (992) | 367 (873) | 0.95 | 0.15b |
FeNO (ppb) | 62 (57) | 44 (33) | 0.056 | 84 (62) | 53 (37) | 0.021 | 32 (24) | 32 (24) | 0.53 | 0.007b |
—Δ%FeNO (%), (range) | 0.7 (69.2), (−68—180) | −19 (57), (−68—157) | 30 (77), (−53—180) | 0.023 | ||||||
ACT (pts) | 15.2 (5.1) | 19.5 (5.2) | 0.0005 | 16.3 (5.5) | 21.7 (4.8) | 0.0023 | 13.6 (4.2) | 16.4 (4.2) | 0.066 | 0.16b |
—ΔACT (pts), (range) | 5.3 (4.5), (−4—16) | 5.4 (5.4), (−3—16) | 2.7 (4.4), (−4—9) | 0.24 | ||||||
%FVC (%) | 91.1 (14.8) | 99.2 (17.5) | 0.031 | 94.7 (14.9) | 100.3 (12.9) | 0.14 | 85.1 (13.2) | 97.7 (23.8) | 0.09 | 0.16b |
%FEV1 (%) | 83.3 (27.6) | 83.9 (24.2) | 0.62 | 77.4 (24.5) | 79.0 (19.9) | 0.36 | 92.1 (30.7) | 91.5 (29.3) | 0.44 | 0.35b |
FEV1 / FVC (%) | 71.1 (13.3) | 68.9 (12.9) | 0.32 | 66.6 (12.8) | 65.2 (12.5) | 0.78 | 77.8 (11.6) | 74.6 (11.8) | 0.11 | 0.026b |
%PEF (%) | 86.2 (28.2) | 89.4 (23.6) | 0.011 | 82.3 (30.8) | 85.3 (24.0) | 0.011 | 92.1 (24.1) | 95.9 (22.7) | 0.53 | 0.29b |
V50/V25 | 3.5 (1.1) | 3.5 (1.1) | 0.61 | 3.5 (1.2) | 3.1 (0.9) | 0.81 | 3.5 (1.1) | 4.1 (1.1) | 0.26 | 0.78b |
daily dose of OCS (mg)§, (range) | 8.4 (5.6), (0.5—20) (n = 16) | 5.0 (5.8), (0—20) (n = 16) | 0.0032 | 7.0 (4.8), (0.5—15) (n = 10) | 2.0 (2.4), (0—6) (n = 10) | 0.008 | 10.8 (6.5), (5—20) (n = 6) | 10.0 (6.5), (2.5—20) (n = 6) | 0.16 | 0.29b |
—ΔOCS (%), (range) | −48.6 (43.3), (−100—0) | −71.3 (37.0), (−100—0) | −10.7 (20.1), (−50—0) | 0.006 | ||||||
exacerbation (/year), n | 5.6 (4.9) | 2.9 (3.7) | 0.002 | 5.6 (5.6) | 2.4 (3.3) | 0.01 | 5.5 (3.9) | 3.6 (4.2) | 0.0498 | 0.77b |
—Δexacerbation (%), (range) | −44.7 (61.4), (−100—125) | − 48.4 (62.6),(− 100—125) | −39.9 (62.6), (− 100—100) | 0.82 |
Assessment of asthma patients with or without ECRS
Predictive factors
variables | effective | non effective | odds ratio(95% CI) (monovariate) | P value | odds ratio(95% CI) (multivariate) | P value |
---|---|---|---|---|---|---|
n = 19 | n = 8 | |||||
gender (male), n (%) | 7 (37) | 1 (13) | 4.1 (0.4–40) | 0.23 | 5.6 (0.28–115) | 0.26 |
age (≥ 65 year-old), n(%) | 6 (32) | 2 (25) | 1.4 (0.2–9.0) | 0.73 | 1.2 (0.05–26.6) | 0.92 |
duration of asthma (≥ 20 years), n(%) | 11 (58) | 4 (50) | 1.4 (0.3–7.2) | 0.71 | – | – |
BMI(kg/m2) ≥ 25, n (%) | 6 (32) | 2 (25) | 1.4 (0.2–9.0) | 0.73 | – | – |
atopic type, n(%) | 16 (84) | 5 (63) | 3.2 (0.5–21) | 0.23 | – | – |
blood eosinophil count≥150(/mm3)a, n (%) | 18 (95) | 7 (88) | 2.6 (0.1–47) | 0.54 | – | – |
FeNO≥50(ppb)a, n (%) | 9 (47) | 3 (38) | 1.5 (0.3–8.1) | 0.64 | – | – |
with maintenance therapy of OCS, n (%) | 10 (59) | 7 (75) | 0.1 (0.01–1.3) | 0.078 | 0.05 (0.001–1.5) | 0.08 |
with ECRS as comorbidity, n (%) | 14 (74) | 2 (25) | 8.4 (1.3–56) | 0.028 | 22.5 (1.5–336) | 0.024 |
Previous treatment with omalizumab
SEB-IgE(+) n = 4 | SEB-IgE(−) n = 4 | p value | |
---|---|---|---|
positive number with favours mepolizumab, n(%) | 1 (25) | 4 (100) | 0.14a |
ECRS as comorbidity, n(%) | 2 (50) | 4 (100) | 0.43a |
change from baseline in ACT score(pts) | 4.5 (7.0) | 3.8 (3.0) | 0.77b |
change from baseline in OCS dosec(%) | −4.8 (8.2) | −64 (41) | 0.046b |
change from baseline in exacerbation(%) | −8.8 (98) | −77 (42) | 0.24b |