Effectiveness of the Polish program for the treatment of severe allergic asthma with omalizumab: a single-center experience

Table 3 Preliminary effectiveness of omalizumab treatment in patients within the NHF program

	Baseline (n = 16)	After 16 weeks (n = 16)	Mean differences (95 % CI)	Responders^b, n(%)	P level^c
Monthly exacerbation rate^a
Mean ± SD	0.36 ± 0.14	0.06 ± 0.11	0,30 (0.20 to 0.40)	16 (100 %)	<0.0001
Median	0.33	0
Min/Max	0.25/0.67	0/0.25
OCS, mg/day
Mean ± SD	12.2 ± 7.5	2.5 ± 5.1	−9,72 (-8.68 to -0.75)	14 (88 %)	0.0001
Median	10	0
Min/Max	5/25	0/20
ACQ, points
Mean ± SD	3.54 ± 0.99	2.41 ± 1.18	−1,13 (-0.97 to -0.29)	15 (94 %)	0.0012
Median	3.7	2.65
Min/Max	1.9/5	0.7/4.1
AQLQ, points
Mean ± SD	3.00 ± 0.71	4.15 ± 1.11	1,15 (0.22 to 1.08)	14 (88 %)	0.0055
Median	2.95	3.75
Min/Max	1.8/4.1	2.9/6.7
FEV1% predicted
Mean ± SD	67.6 ± 23.8	73.4 ± 18.9	6,69 (13.27 to 11.64)	8 (50 %)	0.5521
Median	68	76
Min/Max	31/107	41/104
GETE: Excellent/Good, n%)				1 (6 %)/15 (94 %)

^a calculated as number of exacerbation/months of observations
^b responders were defined as patients with reduced number of exacerbation and or improvement above predefined differences in study end-points: -5 mg, -0.5 points, 0.5 points, 0, 2 l for OCS, ACQ, AQLQ, and FEV1, respectively
^ccomparisons with predefined (clinically important) differences
Abbreviations: ACQ asthma control questionnaire, AQLQ asthma quality of life questionnaire, FEV1 forced expired volume in one second, GETE global effectiveness of treatment evaluation scale, OCS oral corticosteroid, SD standard deviation

ISSN: 1471-2466