2008年 12月 09日
FDA: Omalizumab (marketed as Xolair) Information
Omalizumab for Asthma
N Engl J Med. Volume 354:(25)2689-2695 June 22, 2006臨床的ベネフィット
Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108:184-190.
Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001;18:254-261.
Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001;108:e36-e36.
Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-638.
Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005;60:309-316.
Clinical Review Management of asthma in children
BMJ 2007;335:253-257 (4 August), doi:10.1136/bmj.39255.692222.AE
Alternative treatments include continuous subcutaneous terbutaline, which has been used with success in the past and can be well tolerated. More recently, the anti-IgE monoclonal antibody omalizumab has been used in children with asthma as an alternative to methotrexate. It binds to the IgE epitope that binds the IgE receptor, thus preventing IgE mediated mast cell degranulation. Several trials have shown clinical benefit from omalizumab in the form of significantly fewer exacerbations per patient and a significantly lower percentage of patients having exacerbations. The two weekly or four weekly subcutaneous injections seem to be well tolerated, and some specific benefit seems to be achieved, with measurable reductions in the dose of oral prednisolone needed.
Severe asthma: approach and management
Postgraduate Medical Journal 2008;84:115-120
Global Initiative for Asthma(GINA)："POCKET GUIDE FOR ASTHMA MANAGEMENT AND PREVENTION"には薬剤一覧に掲載のみ
Anti-IgE.Role in therapy - Anti-IgE (omalizumab) is a treatment option limited to patients with elevated serum levels of IgE.
Its current indication is for patients with severe allergic asthma who are uncontrolled on inhaled glucocorticosteroids, although the dose of concurrent treatment has varied in different studies. Improved asthma control is reflected by fewer symptoms, less need for reliever medications, and fewer exacerbations. Further investigations will likely provide additional clarification of the role of anti-IgE in other clinical settings.
Side effects: As indicated by several studies involving asthma patients between the ages of 11 and 50, who were already receiving treatment with glucocorticosteroids (inhaled and/or oral) and long-acting beta 2-agonists, anti-IgE appears to be safe as add-on therapy.
The average wholesale price (AWP) for a 150 mg vial of omalizumab is $541. For dosing every 4 weeks, the price will range approximately from $541 to $1,000 (for 150 mg and 300 mg, respectively). For one year of treatment with these doses, the cost will range from $10,000 to $16,000. For dosing every 2 weeks, the price will range from $800 to $1,400 (for 225 mg and 375 mg, respectively). The total price for a month of treatment with dosing every two weeks is $1,600 to $2,700. For a year of treatment with these doses, the cost will range from $20,000 to $32,000.
An evaluation of the cost-effectiveness of omalizumab for the treatment of severe allergic asthma.
Allergy. 2008 Jun;63(6):670-84.