Volume. 35, No. 2 july. 2011 - The Chest and Heart Association of ...

Chest & Heart Journal Vol. 35, No.-2, July 2011dosing and maximize Omalizumab therapy. Thereis, at present, no reported clinical experience withsuch approaches. 9,10,11CostOmalizumab is considerably more expensive thanconventional asthma therapy. The cost oftreatment may range from $4,000 to $20,000 peryear, depending on the dose, with an average ofapproximately $12,000 per year. This compareswith approximate costs per year of $1,280 forMontelukast, $2,160 for the combination ofFluticasone dipropionate and Salmeterol, and $680for extended release Theophylline. 12Response to treatmentResponse to treatment can take several weeks tobecome apparent. 11 Among patients in a clinicaltrial who had had a response to Omalizumab by 16weeks, 87% had done so by 12 weeks. These datasuggest that patients should be treated for at least12 weeks before efficacy is assessed. Given thatserum IgE levels and the numbers of FcåRIsincrease after therapy is discontinued 12 , it seemsthat treatment needs to be continued for efficacyto persist, but no studies have been reported onthe duration of effects after discontinuation. Iftreatment is interrupted before nine months haveelapsed since the last injection, treatment shouldbe resumed at the dose initially prescribed. 11,12Dosing may need to be adjusted in the event ofsubstantial changes in body weight (Table 1).Adverse EffectsPotential safety concerns identified by the Foodand Drug Administration (FDA) in reviewing trialdata on Omalizumab included risks of thedevelopment of cancer and anaphylaxis. Cancerdeveloped in more patients exposed toOmalizumab than in those who received placebo(20 of 4127 [0.5%] and 5 of 2236 [0.2%],respectively). They were predominantly epithelialor solid-organ cancers; one case of haematologicor lymphatic cancer was noted. Since the majorityof patients treated with Omalizumab have beenobserved for only a year, the effect of longerexposure or of use in patients who are at increasedrisk for cancer is not known. Therefore,Omalizumab probably should not be used inpatients with a history of cancer or a strong familyhistory of cancer until this risk relationship isbetter understood. 11,12,13Omalizumab is intended to prevent any risk ofanaphylaxis, since the agent cannot interact withIgE that is already bound to cell surfaces. However,in clinical trials, three patients (