TY - JOUR T1 - Interim analysis of post-marketing surveillance of omalizumab in Japan JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P4128 AU - Ken Ohta AU - Hajime Yoshisue AU - Yasuo Aoki AU - Takuro Irokawa AU - Masahide Ishigaki AU - Mitsuru Adachi AU - Terumasa Miyamoto Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P4128.abstract N2 - Background: Omalizumab (OMA) was launched as an add-on therapy for patients with uncontrolled severe allergic asthma in Japan in March 2009, at which point post-marketing surveillance began.Methods: All patients prescribed OMA are entered into a prospective, real-life surveillance registry, and are followed up to assess outcomes (adverse events, exacerbations, response by physician’s Global Evaluation of Treatment Effectiveness [GETE], lung function, rescue medication use) over 1 year. We present an interim analysis in patients who have completed at least 4 months of observation.Results: Safety (n=1,259): Adverse reactions occurred in 7.7%, most frequently involving the skin and subcutaneous tissue (2.2%). One case of suspected anaphylaxis was reported (0.08%), but an anti-OMA antibody test was negative.Efficacy (n=1,049): Asthma exacerbations were significantly decreased following the initiation of OMA. Response by physician’s GETE was 60% after 4 months of treatment. Morning and evening peak expiratory flow rate were increased, and rescue medication use was reduced, compared with baseline (all p<0.001).View this table:Table 1Conclusions: This interim analysis suggests that OMA is well tolerated and associated with clinical benefit in Japanese patients. Surveillance is ongoing, and future analyses will continue to provide information on the use of OMA in Japan. ER -