Omalizumab benefits Asian asthma patients

MedWire News: Omalizumab improves disease control in Asian patients with moderate-to-severe asthma without causing any significant adverse events, researchers report in findings that are consistent with those from studies conducted in other ethnic groups.

“The efficacy and safety of the anti-immunoglobulin E antibody, omalizumab, has been widely studied in patients with asthma,” explain Ken Ohta (Teikyo University School of Medicine, Tokyo, Japan) and team.

“However to date, no large studies have been performed in Asian populations,” they add.

To address this, the researchers studied 315 Japanese patients, aged 20–75 years, with moderate-to-severe asthma that remained uncontrolled despite treatment with high-dose inhaled corticosteroids and other standard therapies.

The participants were randomly assigned to receive add-on treatment with omalizumab (n=151) or placebo (n=164) for 16 weeks in a double-blind, parallel-group, multicentre trial.

At the end of the study period, the researchers found that morning peak expiratory flow had improved by a mean of 15.45 l/min in the omalizumab group compared with just 2.25 l/min in the placebo group.

Furthermore, just six patients in the omalizumab group experienced a clinically significant asthma exacerbation during the study period compared with 18 placebo-treated patients. Indeed, patients taking omalizumab were 68% less likely to suffer an exacerbation than those taking placebo.

Patients in the omalizumab group also showed greater improvements in asthma symptom scores, daily life activity scores and sleep scores, and used less rescue medication than those in the placebo group. However, these differences did not reach statistical significance.

The researchers also found that similar proportions of omalizumab- and placebo-treated patients experienced adverse events, at 90.1% and 86.6%, respectively. However, these were mostly mild or moderate in severity, with the most common adverse events being nasopharyngitis, injection site reactions, and headache in the omalizumab group.

Ohta and team conclude in the journal Respirology: “This is the first large randomized controlled trial of omalizumab in an Asian population [and] it confirms the consistent efficacy and favorable safety profile shown in previous studies conducted in the USA or European countries.”

They add: “The results of this study suggest that omalizumab is an effective drug in the Japanese population, and therefore has an important role in the management of 'difficult-to-treat' Japanese patients with severe allergic asthma, in line with global guidelines.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009