Mepolizumab group | Conventional treatment group | p-value | |
---|---|---|---|
N = 43 | N = 28 | ||
Age at study admission (years), mean ± 1 SD | 59.9 ± 14.1 | 56.4 ± 16.3 | NS |
Sex (M/F) | 16/27 | 9/19 | NS |
Age at asthma onset (years), mean ± SD | 41.3 ± 20.0 | 34.4 ± 17.9 | NS |
Age at EGPA onset (years), mean ± SD | 50.4 ± 18.4 | 49.4 ± 15.2 | NS |
Period of time from EGPA onset to study admission (years), mean ± SD | 8.4 ± 8.7 | 6.0 ± 5.4 | NS |
Laboratory data at diagnosis | |||
WBC count (/μL), mean ± 1 SD | 16 220.9 ± 8103.7 | 15 508.2 ± 9173.2 | NS |
Blood eosinophils (/μL), mean ± 1 SD | 7877.2 ± 7018.9 | 7515.8 ± 7461.6 | NS |
MPO-ANCA yes/no (%) | 10/33 (23.3%) | 6/22 (21.4%) | NS |
PR3-ANCA yes/no (%) | 3/40 (7.0%) | 4/24 (14.3%) | NS |
IC > 1.5 mg/mL yes/no (%) | 6/26 (25.7%) | 6/15 (28.6%) | NS |
RF > 15 IU/mL yes/no (%) | 14/22 (38.9%) | 14/11 (56.0%) | NS |
BNP > 18.7 pg/mL yes/no (%) | 19/18 (51.4%) | 11/10 (52.4%) | NS |
IgE IU/mL, median (range) | 432 (56–3176) | 542 (11.4–25,112) | NS |
IgG IU/mL, mean ± SD yes/no (%) | 1562.4 ± 609.5 | 1441.7 ± 503.6 | NS |
Clinical manifestations at diagnosis, yes/no (%) | |||
Asthma | 43/0 (100.0%) | 27/1 (96.4%) | NS |
Paranasal sinusitis | 41/2 (95.3%) | 25/3 (89.3%) | NS |
Eosinophilic otitis media | 12/30 (28.6%) | 4/23 (14.8%) | NS |
Multiple polyneuropathy | 42/1 (97.7%) | 28/0 (100%) | NS |
Minimum MMT score | 3.6 ± 0.9 | 3.3 ± 1.1 | NS |
Pulmonary involvement | 21/18 (53.8%) | 14/14 (50.0%) | NS |
Myocardial involvement | 33/9 (78.6%) | 12/14 (46.2%) | p < 0.01 |
Gastrointestinal tract involvement | 37/2 (94.9%) | 23/3 (88.5%) | NS |
Liver, gallbladder, pancreas | 8/31 (20.5%) | 8/18 (30.8%) | NS |
Renal involvement | 14/27 (34.1%) | 7/21 (25.0%) | NS |
Skin involvement | 27/14 (65.9%) | 15/13 (53.6%) | NS |
Arthralgia | 23/19 (54.8%) | 11/17 (39.3%) | NS |
Myalgia | 8/33 (19.5%) | 3/24 (11.1%) | NS |
Central nervous system involvement | 12/31 (27.9%) | 9/19 (32.1%) | NS |
BVAS | |||
At diagnosis | 31.0 ± 7.3 | 28.3 ± 11.0 | NS |
Before treatment-group allocation | 15.4 ± 5.2 | 7.3 ± 6.4 | < 0.01 |
Relapses before treatment-group allocation | |||
Frequency (times/year), mean ± 1 SD | 1.0 ± 0.9 | 0.4 ± 0.6 | < 0.01 |
Initial treatment | |||
PSL (mg) (mean ± SD) | 42.9 ± 11.7 | 46.4 ± 11.1 | NS |
mPSL pulse yes/no (%) | 29/14 (67.4%) | 22/6 (78.6%) | NS |
Immunosuppressant yes/no (%) | 37/6 (86.0%) | 22/6 (78.6%) | NS |
CYC/AZA/CsA/MTX/RTX | 25/3/6/3/0 | 10/3/7/2/0 | NS |
Maintenance treatment before group allocation | |||
Immunosuppressant yes/no (%) | 33/10 (76.7%) | 21/7 (75.0%) | NS |
CYC/AZA/CSA/MTX/RTX | 7/6/5/13/2 | 6/4/7/4/0 | NS |
PSL (mg) (mean ± SD) | 12.3 ± 5.6 | 8.8 ± 5.0 | < 0.05 |
IVIG yes/no (%) | 35/8 (81.4%) | 16/12 (57.1%) | < 0.05 |