{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T17:01:50Z","timestamp":1788454910975,"version":"build-2803163510"},"reference-count":11,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,11,25]],"date-time":"2018-11-25T00:00:00Z","timestamp":1543104000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005612","name":"Shionogi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005612","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The efficacy and safety of 300 index of reactivity (IR) tablets of house dust mite (HDM) allergen extracts in Japanese pediatric (5\u201016\u00a0years old) patients with allergic rhinitis (AR) were assessed in a double\u2010blind, randomized, placebo\u2010controlled study (JAPIC CTI\u2010152981).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomized 1:1 to HDM sublingual tablets or placebo once daily for 52\u00a0weeks. The primary end\u2010point was average adjusted symptom score (AASS; average of daily Rhinitis Total Symptom Scores, comprising sneezing, rhinorrhea, nasal congestion, and nasal pruritus, adjusted for rescue medication use), analyzed during Weeks 48\u201052 (mixed\u2010effects model for repeated measures).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 438 patients randomized, 403 (92%; 193 active, 210 placebo) completed the study. AASS (least\u2010squares [LS] mean [SE]) during Weeks 48\u201052 was significantly (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0005) lower in the active group compared with placebo (6.32 [0.20] vs 7.27 [0.19]; relative LS mean difference, \u221213%). Immunological responses (IgE and IgG4 antibodies specific to antigens of two HDM species) were significantly greater in the active group compared with placebo (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u00a00.0001). Almost all patients experienced mild or moderate adverse events (AEs). The most common treatment\u2010related AEs were oral pruritus, mouth edema, throat irritation, and ear pruritus. One patient experienced serious pseudocroup (subglottic laryngitis) that recovered. There were no deaths or anaphylaxis requiring the use of injectable adrenaline.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The HDM tablet significantly improved symptoms of HDM\u2010induced perennial AR and was associated with a significant immunological response. The safety profile in pediatric patients was consistent with that in adults, with no new safety concerns.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pai.12984","type":"journal-article","created":{"date-parts":[[2018,10,5]],"date-time":"2018-10-05T11:00:49Z","timestamp":1538737249000},"page":"66-73","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":65,"title":["Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population"],"prefix":"10.1111","volume":"30","author":[{"given":"Yoshitaka","family":"Okamoto","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery, Graduate School of Medicine Chiba University Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeharu","family":"Fujieda","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery University of Fukui Fukui Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuhiro","family":"Okano","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, School of Medicine International University of Health and Welfare Narita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideaki","family":"Hida","sequence":"additional","affiliation":[{"name":"Biostatistics Center Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4050-5153","authenticated-orcid":false,"given":"Shinji","family":"Kakudo","sequence":"additional","affiliation":[{"name":"Project Management Department Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisuke","family":"Masuyama","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery, Graduate School of Medical Science University of Yamanashi Yamanashi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2016.11.001"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2013.11.012"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12996"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599814562166"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.O-08-550"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2010.183095"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anl.2015.08.015"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2011.03700.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2007.01620.x"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.21392"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/ACI.0000000000000075"}],"container-title":["Pediatric Allergy and Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fpai.12984","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pai.12984","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T08:16:17Z","timestamp":1694679377000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pai.12984"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,25]]},"references-count":11,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1111\/pai.12984"],"URL":"https:\/\/doi.org\/10.1111\/pai.12984","archive":["Portico"],"relation":{},"ISSN":["0905-6157","1399-3038"],"issn-type":[{"value":"0905-6157","type":"print"},{"value":"1399-3038","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,25]]},"assertion":[{"value":"2018-05-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}