ゾレア皮下注:喘息抗IgE治療

 「(ゾレア皮下注用150mg投与用」と「レミッチカプセル2・5μg」が時期薬価基準収載予定の目玉薬剤だろう・・・http://www.yakuji.co.jp/entry8392.html


まったくのピカ新のレミッチもκ関係でおもしろい薬剤だが、おそらく私は一生関わることがないだろう薬剤で、“ゾレア皮下注:Omalizumab”の情報を集めてみた・・・

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.




血中のIgE値を測定し、omalizumabの投与量を決定しなければならない。IgE値と体重でその投与量を決定するのだが、4週間に0.016mg/kg体重が推奨量とされる。
2週・4週毎の間隔で皮下投与され、10IU/mlに遊離IgE値が減少するまでとする。モニターはIgE-抗IgE複合体の存在のため無駄。
Omalizumabはかなり高価で、投与量によるが4千ドルから2万ドルで、年平均1万2千ドル。これはmontelukast 1千280ドル、FP+salmeterol(Advair)の2千160ドル、徐放テオフィリン680ドルと比較してみると・・・





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
2007 update版
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.





アナフィラキシー問題:Xolairの市販後調査により2003年6月~2006年12月における推定使用患者数が約57,300例に対し,FDA は124件のアナフィラキシーの症例報告



コスト:(http://www.clevelandclinicmeded.com/medicalpubs/pharmacy/janfeb2004/omalizumab.htm
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.

by internalmedicine | 2008-12-09 17:24 | 呼吸器系  

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