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.