Evaluation of omalizumab therapy in a Chinese versus predominantly Caucasian population: Comparison of clinical data

Aim: Omalizumab (OMA), an anti-IgE antibody, provides clinical improvements in patients (pts) with moderate-to-severe allergic asthma across various ethnicities. Here, we compare the clinical data of OMA from a double-blind randomized placebo (PBO)-controlled study in Chinese pts, with results from studies that include predominantly Caucasian pts. Methods: Efficacy and safety of OMA vs PBO in a Chinese phase III study was compared with 4 global studies (predominantly Caucasian population). A pharmacokinetic-pharmacodynamics (PKPD) model was also used to compare the two populations. Results: Efficacy (Table) and safety of OMA in the Chinese pts was found 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. Conclusion: Clinical efficacy of OMA in the Chinese pt population is comparable to the global studies. This is further supported by the results from the PKPD model. Safety of OMA in Chinese pts was not different from its known safety and tolerability profile.