Baseline characteristics of Biologic Treated Groups vs SNB
(comparator) group
Compared to SNB subjects, neither biologic groups had significantly
different baseline exacerbations or AHE (Table 1). However, they both
showed other baseline severity markers, with significantly higher FENO,
worse lung function and more mOCS dependency.
Compared to SNB subjects, OMA subjects had significantly younger age of
asthma onset (Table 1). They were also more ethnically diverse and were
all atopic. They also had a significantly greater prevalence of
rhinitis, allergic bronchopulmonary aspergillosis (ABPA), and nasal
(polyps/sinus) surgery.
Conversely, compared to SNB subjects, MEPO subjects had a significantly
higher maximum PBE (Table 1), were older, diagnosed with asthma later in
life, and predominantly male. Additionally, they had a significantly
higher prevalence of nasal polyps and nasal (polyps/sinus) surgery but
less dysfunctional breathing.
Omalizumab responseOverall, 99.0%,(104/105) patients completed OMA trials. One person
withdrew due to side-effects. OMA (Figure 1) significantly reduced
exacerbations [Median(IQR), baseline: 5(3) to 0(3) at end-of-trial,
P<0.001], mOCS dose [Median(IQR), baseline: 10(10-20) to
10(5-15) at end-of-trial, P=0.002], AHE [Median(IQR), baseline: 1(2)
to 0(0) at end-of-trial, P=0.003] and the proportion of patients with
multiple (>1) AHE [Baseline: 36.5%,(38/104);
end-of-trial: 15.4%,(16/104), P=0.007]. OMA (Figure 1) also
significantly improved asthma control [Mean (SD) ACQ6, baseline:
2.96(1.26) to 1.64(1.12) at end-of-trial, P <0.001], Clinic
FEV1% [Mean(SD), baseline: 67.34(25.93) to
75.40(21.79) at end-of-trial, P<0.001] and reduced PBE
(cells/μL) [Median(IQR) baseline: 200(400) to 200(200) at
end-of-trial, P=0.002]. However, it did not significantly reduce mOCS
dependency [Baseline: 48.1%, (50/104), end-of-trial: 41.6% (42/101),
P=NS].
Omalizumab responders vs
non-respondersOMA response, as assessed by GETE, was
achieved in 88.5%, (92/104) of subjects completing trials. OMA
responders (supplementary table E2) were significantly older [Mean(SD)
Age, Responder: 53(15) vs non-responder: 44(12), P=0.025] and had
lower prevalence of anxiety [Responder: 26.6%,(21/79) vs
non-responder: 63.6%,(7/11), P=0.031]. In multivariate analysis
(Table 2), anxiety and more AHE at baseline were independently
associated with treatment failure, while more exacerbations at baseline
was independently associated with treatment response.