论文摘要：
Aim
Omalizumab (OMA) provides clinical improvements in patients (pts) with moderate-to-severe allergic asthma across various ethnicities. Here, we compare the clinical data of OMA from PhIII study in Chinese pts, with results from studies that include predominantly Caucasian pts.
Methods
Efficacy and safety of OMA vs PBO in Chinese study was compared with 4 global studies (predominantly Caucasian population). A population pharmacokinetic-pharmacodynamics (PKPD) model was also used to compare the two populations.
Results
Efficacy (Table) and safety of OMA in the Chinese pts was demonstrated to be similar to the pts in the comparator studies. OMA steady-state PK and IgE (free and total) were also similar in all studies.
Table: Efficacy parameters of OMA vs. placebo in the Chinese vs. global studies
Parameter
|
Chinese A2313
(n=608) |
USA 008
(n=525) |
USA 009
(n=546) |
Global Q3662g
(n=848) |
Global A2306
(n=419) |
Study Duration
|
24w |
28w |
28w |
48w |
28w |
| Morning PEF |
8.9 – 12.5€ (FAS)
10.8 – 13.5* (PP) |
8.9 – 11.9†; p<0.05 |
11.7 – 15.6†; p<0.001 |
- |
3.8-10.6€
8.9γ;
p=0.065 |
| FEV1 % predicted |
4.12; p=0.001 |
- |
- |
2.25? p<0.05 |
2.84; p=0.043 |
| AQLQ Overall scores |
0.40‡; p<0.001 |
0.29¥? p0.001 |
0.28¥? p=0.002 |
0.23§; p=0.005 |
0.45¥; p<0.001 |
| GETE responders by investigator assessment |
70.3% / 50.7%‡;
p<0.001 |
53.1% / 33.3%;
p<0.001 |
66.2% / 34.8%;
p<0.001 |
71.1% / 57.2%§;
p<0.001 |
60.5% / 42.8%;
p<0.001 |
| GETE responders by patient self-assessment |
71.9% / 61.6%; p≤0.006 |
60.6% / 38.1%;
p<0.001 |
69.5% / 42.6%;
p<0.001 |
78.8% / 68.6%;
p<0.0026 |
64.3% / 43.3%;
p<0.001 |
€Week 4–24; †Week 4–16; ‡at Week 24;¥at Week 16 (steroid stabilization phase); § at Week 48; γ at Weeks 20-24.
*p<0.05, **range in difference between treatment groups |
Conclusion
Clinical efficacy and PKPD properties of OMA in the Chinese pt population are comparable to the global studies. Safety of OMA in Chinese pts was not different from its known safety and tolerability profile.
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