***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Peanut allergy is a major public health problem that affects 1 % of the population and has no effective therapy . OBJECTIVE To examine the safety and efficacy of oral desensitization in peanut-allergic children in combination with a brief course of anti-IgE mAb ( omalizumab [ Xolair ] ) . METHODS We performed oral peanut desensitization in peanut-allergic children at high risk for developing significant peanut-induced allergic reactions .  Omalizumab was administered before and during oral peanut desensitization . RESULTS We enrolled 13 children ( median age , 10 years ) , with a median peanut-specific IgE level of 229 kU(A)/L and a median total serum IgE level of 621 kU/L , who failed an initial double-blind placebo-controlled food challenge at peanut flour doses of 100 mg or less . After pretreatment with omalizumab , all 13 subjects tolerated the initial 11 desensitization doses given on the first day , including the maximum dose of 500 mg peanut flour ( cumulative dose , 992 mg , equivalent to > 2 peanuts ) , requiring minimal or no rescue therapy . Twelve subjects then reached the maximum maintenance dose of 4000 mg peanut flour per day in a median time of 8 weeks , at which point omalizumab was discontinued . All 12 subjects continued on 4000 mg peanut flour per day and subsequently tolerated a challenge with 8000 mg peanut flour ( equivalent to about 20 peanuts ) , or 160 to 400 times the dose tolerated before desensitization . During the study , 6 of the 13 subjects experienced mild or no allergic reactions , 5 subjects had grade 2 reactions , and 2 subjects had grade 3 reactions , all of which responded rapidly to treatment . CONCLUSIONS Among children with high-risk peanut allergy , treatment with omalizumab may facilitate rapid oral desensitization and qualitatively improve the desensitization process Background : Oral immunotherapy ( OIT ) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted . Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment . Objective : We sought to test the safety , effectiveness , and feasibility of early OIT ( E‐OIT ) in the treatment of peanut allergy . Methods : We enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy . Qualifying subjects reacted to peanut during an entry food challenge and were block‐r and omized 1:1 to receive E‐OIT at goal maintenance doses of 300 or 3000 mg/d in a double‐blinded fashion . The primary end point , sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy ( 4‐SU ) , was assessed by double‐blinded , placebo‐controlled food challenge either upon achieving 4 prespecified criteria , or after 3 maintenance years . Peanut‐specific immune responses were serially analyzed . Outcomes were compared with 154 matched st and ard‐care controls . Results : Of 40 consented subjects , 3 ( 7.5 % ) did not qualify . Overall , 29 of 37 ( 78 % ) in the intent‐to‐treat analysis achieved 4‐SU ( 300‐mg arm , 17 of 20 [ 85 % ] ; 3000 mg , 12 of 17 [ 71 % ] , P = .43 ) over a median of 29 months . Per‐ protocol , the overall proportion achieving 4‐SU was 29 of 32 ( 91 % ) . Peanut‐specific IgE levels significantly declined in E‐OIT‐treated children , who were 19 times more likely to successfully consume dietary peanut than matched st and ard‐care controls , in whom peanut‐specific IgE levels significantly increased ( relative risk , 19.42 ; 95 % CI , 8.7‐43.7 ; P < .001 ) . Allergic side effects during E‐OIT were common but all were mild to moderate . Conclusions : At both doses tested , E‐OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary re introduction Background : Peanut oral immunotherapy is a promising approach to peanut allergy , but reactions are frequent , and some patients can not be desensitized . The anti‐IgE medication omalizumab ( Xolair ; Genentech , South San Francisco , Calif ) might allow more rapid peanut updosing and decrease reactions . Objective : We sought to evaluate whether omalizumab facilitated rapid peanut desensitization in highly allergic patients . Methods : Thirty‐seven subjects were r and omized to omalizumab ( n = 29 ) or placebo ( n = 8) . After 12 weeks of treatment , subjects underwent a rapid 1‐day desensitization of up to 250 mg of peanut protein , followed by weekly increases up to 2000 mg . Omalizumab was then discontinued , and subjects continued on 2000 mg of peanut protein . Subjects underwent an open challenge to 4000 mg of peanut protein 12 weeks after stopping study drug . If tolerated , subjects continued on 4000 mg of peanut protein daily . Results : The median peanut dose tolerated on the initial desensitization day was 250 mg for omalizumab‐treated subjects versus 22.5 mg for placebo‐treated subject . Subsequently , 23 ( 79 % ) of 29 subjects r and omized to omalizumab tolerated 2000 mg of peanut protein 6 weeks after stopping omalizumab versus 1 ( 12 % ) of 8 receiving placebo ( P < .01 ) . Twenty‐three subjects receiving omalizumab versus 1 subject receiving placebo passed the 4000‐mg food challenge . Overall reaction rates were not significantly lower in omalizumab‐treated versus placebo‐treated subjects ( odds ratio , 0.57 ; P = .15 ) , although omalizumab‐treated subjects were exposed to much higher peanut doses . Conclusion : Omalizumab allows subjects with peanut allergy to be rapidly desensitized over as little as 8 weeks of peanut oral immunotherapy . In the majority of subjects , this desensitization is sustained after omalizumab is discontinued . Additional studies will help clarify which patients would benefit most from this approach BACKGROUND Peanut oral immunotherapy , using a variety of approaches , has been previously shown to induce desensitization in peanut-allergic subjects , but no products have been approved for clinical use by regulatory agencies . OBJECTIVE We performed the first phase 2 multicentered study to assess the safety and efficacy of AR101 , a novel oral biologic drug product . METHODS A r and omized , double-blind , placebo-controlled trial was conducted at 8 US centers . Eligible subjects were 4 to 26 years old , sensitized to peanut , and had dose-limiting symptoms to ≤143 mg of peanut protein in a screening double-blind , placebo-controlled food challenge ( DBPCFC ) . Subjects were r and omized 1:1 to daily AR101 or placebo and gradually up-dosed from 0.5 to 300 mg/day . The primary endpoint was the proportion of subjects in each arm able to tolerate ≥443 mg ( cumulative peanut protein ) at exit DBPCFC with no or mild symptoms . RESULTS Fifty-five subjects ( 29 AR101 , 26 placebo ) were enrolled . In the intention-to-treat analysis , 23 of 29 ( 79 % ) and 18 of 29 ( 62 % ) AR101 subjects tolerated ≥443 mg and 1043 mg at exit DBPCFC , respectively , versus 5 of 26 ( 19 % ) and 0 of 26 ( 0 % ) placebo subjects ( both P < .0001 ) . Compared with placebo , AR101 significantly reduced symptom severity during exit DBPCFCs and modulated peanut-specific cellular and humoral immune responses . Gastrointestinal ( GI ) symptoms were the most common treatment-related adverse events ( AEs ) in both groups , with 6 AR101 subjects ( 21 % ) withdrawing , 4 of those due primarily to recurrent GI AEs . CONCLUSIONS In this study , AR101 demonstrated an acceptable safety profile and demonstrated clinical activity as a potential immunomodulatory treatment option in peanut-allergic children over the age of 4 , adolescents , and young adults BACKGROUND Although promising results have emerged regarding oral immunotherapy ( OIT ) and sublingual immunotherapy ( SLIT ) for the treatment of peanut allergy ( PA ) , direct comparisons of these approaches are limited . OBJECTIVE This study was conducted to compare the safety , efficacy , and mechanistic correlates of peanut OIT and SLIT . METHODS In this double-blind study children with PA were r and omized to receive active SLIT/placebo OIT or active OIT/placebo SLIT . Doses were escalated to 3.7 mg/d ( SLIT ) or 2000 mg/d ( OIT ) , and subjects were rechallenged after 6 and 12 months of maintenance . After unblinding , therapy was modified per protocol to offer an additional 6 months of therapy . Subjects who passed challenges at 12 or 18 months were taken off treatment for 4 weeks and rechallenged . RESULTS Twenty-one subjects aged 7 to 13 years were r and omized . Five discontinued therapy during the blinded phase . Of the remaining 16 , all had a greater than 10-fold increase in challenge threshold after 12 months . The increased threshold was significantly greater in the active OIT group ( 141- vs 22-fold , P = .01 ) . Significant within-group changes in skin test results and peanut-specific IgE and IgG4 levels were found , with overall greater effects with OIT .  Adverse reactions were generally mild but more common with OIT ( P < .001 ) , including moderate reactions and doses requiring medication . Four subjects had sustained unresponsiveness at study completion . CONCLUSION OIT appeared far more effective than SLIT for the treatment of PA but was also associated with significantly more adverse reactions and early study withdrawal . Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects Background : Reports on oral immunotherapy ( OIT ) for anaphylactic food allergy are lacking . We investigated the efficacy and safety of peanut OIT for anaphylactic patients . Methods : We enrolled 22 peanut anaphylactic patients who underwent OIT between 2011 and 2013 , all of whom demonstrated anaphylaxis during a baseline double-blind , placebo-controlled food challenge . After starting in-hospital OIT , participants gradually increased ingestion to 795 mg of peanut protein per day at home and then took a maintenance dose ( 795 mg ) daily . After 3 asymptomatic months , participants underwent an oral food challenge ( OFC ) of 795 mg after 2 weeks of peanut avoidance to confirm sustained unresponsiveness . The historical control group consisted of 11 patients with anaphylaxis by OFC and underwent the second OFC after 2 years . Results : All patients ( 22/22 ) achieved desensitization by 8 months after starting OIT and completed the protocol within 2 years . Two years later , 15/22 patients ( 68.1 % ) in the OIT group achieved sustained unresponsiveness , whereas only 2 ( 18.1 % ) in the control group passed the second OFC . After 2 years , the median peanut-specific IgE had significantly decreased ( from 38.5 to 12.4 kUA/L ) in the OIT group , but not in the control group . Median peanut- and Ara h 2-specific IgG4 in the OIT group had significantly increased from baseline after 1 month . The adverse reaction rate per ingestion was 43 % in hospital and 5 % at home . Three patients received adrenaline at the hospital and 2 at home . Conclusions : These data suggest that for patients with peanut anaphylaxis , OIT can increase the threshold and support achieving sustained unresponsiveness with relative safety Background Peanut allergy is severe and rarely resolves BACKGROUND Open-label oral immunotherapy ( OIT ) protocol s have been used to treat small numbers of patients with peanut allergy .  Peanut OIT has not been evaluated in double-blind , placebo-controlled trials . OBJECTIVE To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind , placebo-controlled study . METHODS In this multicenter study , children ages 1 to 16 years with peanut allergy received  OIT with peanut flour or placebo . Initial escalation , build-up , and maintenance phases were followed by an oral food challenge ( OFC ) at approximately 1 year . Titrated skin prick tests ( SPTs ) and laboratory studies were performed at regular intervals . RESULTS Twenty-eight subjects were enrolled in the study . Three peanut OIT subjects withdrew early in the study because of allergic side effects . During the double-blind , placebo-controlled food challenge , all remaining peanut OIT 
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Use of a rush treatment phase and targeting a higher maintenance dose were associated with a higher risk and frequency of epinephrine  use , while using co-treatments in addition to POIT was associated with a lower risk of treatment discontinuation due to adverse events .
While adverse events to POIT are common , this study provides promising explorative evidence that certain modifications to existing treatment protocol s could significantly improve treatment outcomes