Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial
Purpose Of The Study: To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among children with peanut allergy. Study Population: The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who sh...
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Veröffentlicht in: | Pediatrics (Evanston) 2019-12, Vol.144 (Supplement_1), p.S34-S34 |
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description | Purpose Of The Study: To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among children with peanut allergy. Study Population: The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who showed objective signs and symptoms of reactivity at an eliciting dose of ≤300 mg of peanut protein during a double-blinded, placebo-controlled food challenge. Methods: This study was a phase 3, randomized, double-blinded, placebo-controlled multicenter trial. Study participants were stratified into low- (≤10 mg) and high-eliciting dose (10–300 mg) subgroups on the basis of participants' screening eliciting dose. Participants were then randomly assigned into groups receiving a daily epicutaneous patch containing 250 µg of peanut protein (n = 238) or a daily placebo patch (n = 118). Treatment response was defined as a posttreatment eliciting dose of ≥300 or ≥1000 mg of peanut protein for the pretreatment low- and high-eliciting dose subgroups, respectively. The treatment effect of the immunotherapy was determined by the response rate difference between the treatment and placebo groups after 12 months. A margin of 15% was selected as the lower bound of the 95% confidence interval (CI) for determining a positive trial result. The incidence of treatment-emergent adverse events (TEAEs) was also followed in each group. Results: After 12 months, the response rates of the treatment (35.3%) and placebo (13.6%) groups were compared, showing a difference of 21.7% that was statistically significant (P < .001). However, the resulting lower bound of the 95% CI was 12.4%, which did not achieve the pretrial 15% criterion for clinically relevant significance. The incidence of TEAEs was 95.4% in the treatment group and 89% in the placebo group, in which application site reactions were the most common TEAE observed in both groups. There were 4 TEAEs in 3 treatment group participants that were classified as moderate anaphylactic reactions, all cases were appropriately treated, and 2 of these participants permanently discontinued the study. Conclusions: This study demonstrated a statistically significant difference between response rates of the peanut patch and placebo patch groups on the basis of eliciting doses during food challenges before and after the 12-month trial period. The results could not be considered a positive trial because the lower bound of the 95% CI was not met. |
doi_str_mv | 10.1542/peds.2019-2461YY |
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Study Population: The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who showed objective signs and symptoms of reactivity at an eliciting dose of ≤300 mg of peanut protein during a double-blinded, placebo-controlled food challenge. Methods: This study was a phase 3, randomized, double-blinded, placebo-controlled multicenter trial. Study participants were stratified into low- (≤10 mg) and high-eliciting dose (10–300 mg) subgroups on the basis of participants' screening eliciting dose. Participants were then randomly assigned into groups receiving a daily epicutaneous patch containing 250 µg of peanut protein (n = 238) or a daily placebo patch (n = 118). Treatment response was defined as a posttreatment eliciting dose of ≥300 or ≥1000 mg of peanut protein for the pretreatment low- and high-eliciting dose subgroups, respectively. The treatment effect of the immunotherapy was determined by the response rate difference between the treatment and placebo groups after 12 months. A margin of 15% was selected as the lower bound of the 95% confidence interval (CI) for determining a positive trial result. The incidence of treatment-emergent adverse events (TEAEs) was also followed in each group. Results: After 12 months, the response rates of the treatment (35.3%) and placebo (13.6%) groups were compared, showing a difference of 21.7% that was statistically significant (P < .001). However, the resulting lower bound of the 95% CI was 12.4%, which did not achieve the pretrial 15% criterion for clinically relevant significance. The incidence of TEAEs was 95.4% in the treatment group and 89% in the placebo group, in which application site reactions were the most common TEAE observed in both groups. There were 4 TEAEs in 3 treatment group participants that were classified as moderate anaphylactic reactions, all cases were appropriately treated, and 2 of these participants permanently discontinued the study. Conclusions: This study demonstrated a statistically significant difference between response rates of the peanut patch and placebo patch groups on the basis of eliciting doses during food challenges before and after the 12-month trial period. The results could not be considered a positive trial because the lower bound of the 95% CI was not met.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.2019-2461YY</identifier><language>eng</language><publisher>Evanston: American Academy of Pediatrics</publisher><subject>Allergies ; Anaphylaxis ; Children ; Clinical trials ; Food allergies ; Immunotherapy ; Incidence ; Ingestion ; Lower bounds ; Pediatrics ; Population studies ; Proteins ; Statistical analysis</subject><ispartof>Pediatrics (Evanston), 2019-12, Vol.144 (Supplement_1), p.S34-S34</ispartof><rights>Copyright American Academy of Pediatrics Dec 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids></links><search><creatorcontrib>Podgorski, Christopher A.</creatorcontrib><creatorcontrib>Leo, Harvey</creatorcontrib><title>Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial</title><title>Pediatrics (Evanston)</title><description>Purpose Of The Study: To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among children with peanut allergy. Study Population: The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who showed objective signs and symptoms of reactivity at an eliciting dose of ≤300 mg of peanut protein during a double-blinded, placebo-controlled food challenge. Methods: This study was a phase 3, randomized, double-blinded, placebo-controlled multicenter trial. Study participants were stratified into low- (≤10 mg) and high-eliciting dose (10–300 mg) subgroups on the basis of participants' screening eliciting dose. Participants were then randomly assigned into groups receiving a daily epicutaneous patch containing 250 µg of peanut protein (n = 238) or a daily placebo patch (n = 118). Treatment response was defined as a posttreatment eliciting dose of ≥300 or ≥1000 mg of peanut protein for the pretreatment low- and high-eliciting dose subgroups, respectively. The treatment effect of the immunotherapy was determined by the response rate difference between the treatment and placebo groups after 12 months. A margin of 15% was selected as the lower bound of the 95% confidence interval (CI) for determining a positive trial result. The incidence of treatment-emergent adverse events (TEAEs) was also followed in each group. Results: After 12 months, the response rates of the treatment (35.3%) and placebo (13.6%) groups were compared, showing a difference of 21.7% that was statistically significant (P < .001). However, the resulting lower bound of the 95% CI was 12.4%, which did not achieve the pretrial 15% criterion for clinically relevant significance. The incidence of TEAEs was 95.4% in the treatment group and 89% in the placebo group, in which application site reactions were the most common TEAE observed in both groups. There were 4 TEAEs in 3 treatment group participants that were classified as moderate anaphylactic reactions, all cases were appropriately treated, and 2 of these participants permanently discontinued the study. Conclusions: This study demonstrated a statistically significant difference between response rates of the peanut patch and placebo patch groups on the basis of eliciting doses during food challenges before and after the 12-month trial period. The results could not be considered a positive trial because the lower bound of the 95% CI was not met.</description><subject>Allergies</subject><subject>Anaphylaxis</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Food allergies</subject><subject>Immunotherapy</subject><subject>Incidence</subject><subject>Ingestion</subject><subject>Lower bounds</subject><subject>Pediatrics</subject><subject>Population studies</subject><subject>Proteins</subject><subject>Statistical analysis</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNo1kU1PwzAMhiMEEmNw5xiJcyFJP5Zxm6YCk5CoYIB2qrLU3oLapCTtYfwf_icdg5Mtv49sWQ8hl5xd8zQRNy1U4VowPo1EkvHV6oiMOJvKKBGT9JiMGIt5lDCWnpKzED4YY0k6ESPynSOC7qhDmrdG952y4PpAF03TW9dtwat2R9_Ah2FY1ErD2lFn6TMo3Zmh6RwtQNm-o4V3HRhLF3YD4TebNc5u6Hxr6sqDpe-m2_7Ds7oGv9nd0uUWaJEXi2X-Qp-VrVxjvqCi89pYo1VNl96o-pycoKoDXPzVMXm9y5fzh-jx6X4xnz1Gmku-i3issUItdILxBIWYykymUqqMaQ2ITFWAbMJSzGSFU0CBqcCEr0WlNWaxisfk6rC39e6zH74oP1zv7XCyFLHIZCZkFg8UO1DauxA8YNl60yi_Kzkr9zLKvYxyL6M8yIh_AIrEgYs</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Podgorski, Christopher A.</creator><creator>Leo, Harvey</creator><general>American Academy of Pediatrics</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope></search><sort><creationdate>20191201</creationdate><title>Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial</title><author>Podgorski, Christopher A. ; Leo, Harvey</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c181y-13cfdfc2c4f37f229868588a60cceff0adef0705f68df9ef2f52f41b2dccf63a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Allergies</topic><topic>Anaphylaxis</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Food allergies</topic><topic>Immunotherapy</topic><topic>Incidence</topic><topic>Ingestion</topic><topic>Lower bounds</topic><topic>Pediatrics</topic><topic>Population studies</topic><topic>Proteins</topic><topic>Statistical analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Podgorski, Christopher A.</creatorcontrib><creatorcontrib>Leo, Harvey</creatorcontrib><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Pediatrics (Evanston)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Podgorski, Christopher A.</au><au>Leo, Harvey</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial</atitle><jtitle>Pediatrics (Evanston)</jtitle><date>2019-12-01</date><risdate>2019</risdate><volume>144</volume><issue>Supplement_1</issue><spage>S34</spage><epage>S34</epage><pages>S34-S34</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><abstract>Purpose Of The Study: To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among children with peanut allergy. Study Population: The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who showed objective signs and symptoms of reactivity at an eliciting dose of ≤300 mg of peanut protein during a double-blinded, placebo-controlled food challenge. Methods: This study was a phase 3, randomized, double-blinded, placebo-controlled multicenter trial. Study participants were stratified into low- (≤10 mg) and high-eliciting dose (10–300 mg) subgroups on the basis of participants' screening eliciting dose. Participants were then randomly assigned into groups receiving a daily epicutaneous patch containing 250 µg of peanut protein (n = 238) or a daily placebo patch (n = 118). Treatment response was defined as a posttreatment eliciting dose of ≥300 or ≥1000 mg of peanut protein for the pretreatment low- and high-eliciting dose subgroups, respectively. The treatment effect of the immunotherapy was determined by the response rate difference between the treatment and placebo groups after 12 months. A margin of 15% was selected as the lower bound of the 95% confidence interval (CI) for determining a positive trial result. The incidence of treatment-emergent adverse events (TEAEs) was also followed in each group. Results: After 12 months, the response rates of the treatment (35.3%) and placebo (13.6%) groups were compared, showing a difference of 21.7% that was statistically significant (P < .001). However, the resulting lower bound of the 95% CI was 12.4%, which did not achieve the pretrial 15% criterion for clinically relevant significance. The incidence of TEAEs was 95.4% in the treatment group and 89% in the placebo group, in which application site reactions were the most common TEAE observed in both groups. There were 4 TEAEs in 3 treatment group participants that were classified as moderate anaphylactic reactions, all cases were appropriately treated, and 2 of these participants permanently discontinued the study. Conclusions: This study demonstrated a statistically significant difference between response rates of the peanut patch and placebo patch groups on the basis of eliciting doses during food challenges before and after the 12-month trial period. The results could not be considered a positive trial because the lower bound of the 95% CI was not met.</abstract><cop>Evanston</cop><pub>American Academy of Pediatrics</pub><doi>10.1542/peds.2019-2461YY</doi><oa>free_for_read</oa></addata></record> |
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subjects | Allergies Anaphylaxis Children Clinical trials Food allergies Immunotherapy Incidence Ingestion Lower bounds Pediatrics Population studies Proteins Statistical analysis |
title | Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial |
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