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

Chest & Heart Journal Vol. 35, No.-2, July 2011these trials, patients had had asthma for at leastone year and required treatment with inhaledcorticosteroids. All patients had at least onepositive skin test to a perennial aeroallergen(specifically, dust mites, cockroaches, or dog or catdander), as well as an elevated total serum IgElevel. During the course of each trial, inhaledcorticosteroids were initially maintained at a stabledose, followed by a phase of dose reduction to thelowest dose required for asthma control. 6,7,8These trials all demonstrated a clinical benefit fromOmalizumab, although the specific findings varied.Three of the trials evaluated patients withmoderate-to-severe persistent asthma (requiringdoses of inhaled Beclomethasone, or its equivalent,ranging from 168 to 1200 ìg per day). Two of thesethree trials included adolescents and adults, andone was a study of children 6 to 12 years of age. Inthese three trials, treatment with Omalizumab ascompared with placebo was associated withsignificantly fewer exacerbations of asthma perpatient, and a significantly lower percentage ofpatients had an exacerbation. In addition, the doseof inhaled corticosteroids required to controlsymptoms was significantly less among patientstreated with Omalizumab than among those whoreceived placebo. 6The fourth trial evaluated patients with moresevere asthma who required high-dose inhaledcorticosteroids for symptom control (Fluticasone,e”1000 ìg per day). In this trial, no significant effecton the frequency of exacerbations was seen,although the dose of inhaled corticosteroidsrequired to control symptoms was significantlylower among patients treated with Omalizumab. 6A fifth clinical trial involved patients who requiredat least 1000 ìg per day of inhaled Beclomethasoneplus a long-acting bronchodilator for symptom control.The study demonstrated a decrease in the rate ofexacerbations of asthma only after adjustment foran imbalance in the number of exacerbations in theyear before enrollment. Among several secondaryoutcomes in these trials, quality-of-life measuresstand out as being notably improved. 6,7,8,9Considerations for IgE blocker Therapy• Patient at least 12 years of age• Evidence of reversible disease (such as 12% orgreater improvement in FEV1 with at least a200-ml increase or 20% or greater improvementin PEF)• IgE level e” 30 IU/ml• Evidence of specific allergic sensitivity (i.e.,positive skin test or blood test for IgE)• Inadequately controlled Asthma despite mediumdose of inhaled corticosteroids for at least threemonths in combination with a trial of long-actinginhaled beta2 agonists or a Leukotrienemodifier• Systemic corticosteroids or high-dose inhaledcorticosteroids required to maintain adequatecontrol• As directly observable therapy in patients whoare not adherent to prescribed therapyClinical UseThe role of Omalizumab in the management ofasthma has not yet been precisely defined. Patientswith persistent asthma (defined as asthma withsymptoms that occur more than two days a weekor nocturnal symptoms that occur more than twicea month 9,10 have several treatment options inaddition to the use of inhaled â-adrenergic agonists.These include environmental control (i.e., theelimination or minimization of exposure toaeroallergens), pharmacologic control (i.e., the useof inhaled corticosteroids, Leukotriene modifiers,or both), and possibly, immunologic control (i.e.,immunotherapy for relevant antigens). In addition,evaluation for coexisting conditions such as allergicrhinitis, sinusitis, and gastroesophageal refluxdisease may prove beneficial.Patients who are particularly likely to benefit fromthe use of Omalizumab include those with evidenceof sensitization to perennial aeroallergens whorequire high doses of inhaled corticosteroids thathave a potential for adverse side effects, those withfrequent exacerbations of asthma associated withunstable disease, and possibly, those with severesymptoms related in part to poor adherence todaily medication. Analyses of pooled data frompublished clinical trials have indicated that patientswho had a response to Omalizumab had a ratio ofobserved to expected forced expiratory volume inone second (FEV1) of less than 65%, were takingdoses of inhaled corticosteroids equivalent to morethan 800 ìg of Beclomethasone dipropionate per122