{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T13:57:48Z","timestamp":1791295068870,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,11,22]],"date-time":"2018-11-22T00:00:00Z","timestamp":1542844800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"ALK, Hoersholm, Denmark"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Allergy"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This randomized, double\u2010blind trial was conducted to determine the optimal dose for clinical efficacy of the <jats:styled-content style=\"fixed-case\">SQ<\/jats:styled-content> tree <jats:styled-content style=\"fixed-case\">SLIT<\/jats:styled-content>\u2010tablet. An environmental exposure chamber (<jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content>) was used to reduce variability of allergen exposure and allow investigation of symptom reduction towards different species from the birch homologous group in separate <jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content> sessions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eligible subjects (N\u00a0=\u00a0219) were randomized to receive treatment with placebo or the <jats:styled-content style=\"fixed-case\">SQ<\/jats:styled-content> tree <jats:styled-content style=\"fixed-case\">SLIT<\/jats:styled-content>\u2010tablet (2, 7, or 12 <jats:styled-content style=\"fixed-case\">DU<\/jats:styled-content>) for 24\u00a0weeks. <jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content> pollen challenges were conducted outside the birch pollen season and included four birch and two oak <jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content> sessions. The primary efficacy endpoint was the average allergic rhinoconjunctivitis (<jats:styled-content style=\"fixed-case\">ARC<\/jats:styled-content>) total symptom score (<jats:styled-content style=\"fixed-case\">TSS<\/jats:styled-content>) after 24\u00a0weeks of treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was a statistically significantly lower <jats:styled-content style=\"fixed-case\">TSS<\/jats:styled-content> during the 24\u2010week birch <jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content> session for 7 <jats:styled-content style=\"fixed-case\">DU<\/jats:styled-content> and 12 <jats:styled-content style=\"fixed-case\">DU<\/jats:styled-content> compared to placebo with relative differences of 24% (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.03) and 25% (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.02). For the 24\u2010week oak <jats:styled-content style=\"fixed-case\">EEC<\/jats:styled-content> session, there was a statistically significant difference for 12 <jats:styled-content style=\"fixed-case\">DU<\/jats:styled-content> (24%, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.03). IgE and IgG4 measurements supported these findings and demonstrated cross\u2010reactivity to all other species within the birch homologous group. Treatment was well\u2010tolerated with the most frequently reported adverse reactions being the local reactions in the oral cavity of mild\u2010to\u2010moderate severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This trial demonstrates that the <jats:styled-content style=\"fixed-case\">SQ<\/jats:styled-content> tree <jats:styled-content style=\"fixed-case\">SLIT<\/jats:styled-content>\u2010tablet reduce <jats:styled-content style=\"fixed-case\">ARC<\/jats:styled-content> symptoms triggered by birch or oak pollen. The optimal dose for further development was 12 <jats:styled-content style=\"fixed-case\">DU<\/jats:styled-content>. Clinical and immunological findings suggest that the tablet may be used to treat allergies to all species within the birch homologous group.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.13606","type":"journal-article","created":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T10:40:08Z","timestamp":1537353608000},"page":"361-369","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":70,"title":["A birch sublingual allergy immunotherapy tablet reduces rhinoconjunctivitis symptoms when exposed to birch and oak and induces IgG<sub>4<\/sub> to allergens from all trees in the birch homologous group"],"prefix":"10.1111","volume":"74","author":[{"given":"Peter","family":"Couroux","sequence":"first","affiliation":[{"name":"Inflamax Research Limited Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Ipsen","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8351-8080","authenticated-orcid":false,"given":"Brian Sonne","family":"Stage","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakob Thomas","family":"Damkj\u00e6r","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Abildgaard","family":"Steffensen","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Marie","family":"Salapatek","sequence":"additional","affiliation":[{"name":"Inflamax Research Limited Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaare","family":"Lund","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter Adler","family":"W\u00fcrtzen","sequence":"additional","affiliation":[{"name":"ALK Hoersholm Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,22]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2006.01293.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1159\/000151243"},{"key":"e_1_2_9_4_1","unstructured":"EMEA.Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases. 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