One year treatment with omalizumab is effective and well tolerated in Japanese Patients with moderate-to-severe persistent asthma.
BACKGROUND
We have previously demonstrated that addition of omalizumab to standard therapy improved asthma control by significantly improving lung function and reducing asthma exacerbations in Japanese patients with moderate-to-severe asthma. The aim of this study was to evaluate the effects of omalizumab on long-term disease control in Japanese patients with moderate-to-severe persistent asthma.


METHODS
An open-label, 48-week study was conducted in 133 Japanese patients with moderate-to-severe persistent asthma. Omalizumab was administered subcutaneously every 2 or 4 weeks based on serum IgE level and body weight in each patient.


RESULTS
Treatment with omalizumab significantly improved lung function. A subgroup of patients with inadequately controlled severe persistent asthma, despite high dose inhaled corticosteroids and other multiple controller therapies, which corresponds to the Japanese label (label population), showed greater improvements in morning PEF and FEV(1) than the whole study population (full Analysis Set). Serum free IgE levels decreased to below the target and were maintained during the treatment period in almost all patients. The majority of adverse events were mild-to-moderate in severity and there was no trend toward an increase in incidence of adverse events with increase in duration of omalizumab. In addition, the profile of adverse events in this study was similar to that in a 16-week, placebo-controlled study which the present authors had conducted previously in Japan. There were no anaphylactic reactions and no anti-omalizumab antibodies were detected.


CONCLUSIONS
Long-term treatment with omalizumab is effective and well tolerated in Japanese patients with moderate-to-severe persistent asthma.
Ohta
Ken
K
Division of Respiratory Medicine, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan. kenohta@med.teikyo-u.ac.jp
Yamamoto
Manabu
M
Sato
Norio
N
Ikeda
Kimitoshi
K
Miyamoto
Terumasa
T
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D018450:Disease Progression; D004341:Drug Evaluation; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007279:Injections, Subcutaneous; D007564:Japan; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D012129:Respiratory Function Tests; D012720:Severity of Illness Index
D000305:Adrenal Cortex Hormones; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E