{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T14:16:00Z","timestamp":1785420960573,"version":"3.56.0"},"reference-count":35,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,3,29]],"date-time":"2016-03-29T00:00:00Z","timestamp":1459209600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"HAL Allergy BV"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Allergy"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The safety and tolerability of a mite allergoid subcutaneous allergen immunotherapy (<jats:styled-content style=\"fixed-case\">SCIT<\/jats:styled-content>) product was previously established. The aim of this study (EudraCT number: 2011\u2013000393\u201361) was to find the optimally safe and effective allergoid dose by evaluating several dosages in patients with house dust mite (<jats:styled-content style=\"fixed-case\">HDM<\/jats:styled-content>)\u2010induced allergic rhinoconjunctivitis (<jats:styled-content style=\"fixed-case\">ARC<\/jats:styled-content>) using a titrated nasal provocation test (<jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In total, 290 adult <jats:styled-content style=\"fixed-case\">ARC<\/jats:styled-content> patients (148 females; 142 males) with established <jats:styled-content style=\"fixed-case\">HDM<\/jats:styled-content> allergy and with a positive <jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content> were randomized to receive placebo or mite allergoid <jats:styled-content style=\"fixed-case\">SCIT<\/jats:styled-content> 6667, 20 000, 50 000 or 100 000 <jats:styled-content style=\"fixed-case\">AU<\/jats:styled-content>eq\/ml for 12 months. Patients were updosed weekly, followed by monthly maintenance dosing. The primary study endpoint comprised the clinical response to <jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content> after 12 months of treatment. Secondary endpoints included response to <jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content> after 6 months, <jats:styled-content style=\"fixed-case\">PNIF<\/jats:styled-content> measurements, symptom and medication scores during the last 8 weeks of treatment, serum immunoglobulins and safety assessments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After 12 months, a dose\u2013response was observed showing statistically significant improvements in the <jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content> with <jats:styled-content style=\"fixed-case\">SCIT<\/jats:styled-content> concentrations of \u226520 000 <jats:styled-content style=\"fixed-case\">AU<\/jats:styled-content>eq\/ml, while no significantly different outcomes were reached after 6 months. Specific serum IgG and IgG<jats:sub>4<\/jats:sub> levels were dose dependently increased. In the highest dose group, more treatment\u2010emergent adverse events were observed compared with the lower dose groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this mite allergoid <jats:styled-content style=\"fixed-case\">SCIT<\/jats:styled-content> dose finding study in <jats:styled-content style=\"fixed-case\">HDM<\/jats:styled-content>\u2010induced <jats:styled-content style=\"fixed-case\">ARC<\/jats:styled-content>, concentrations of \u226520 000 <jats:styled-content style=\"fixed-case\">AU<\/jats:styled-content>eq\/ml showed both immunological effects and clinical efficacy in the <jats:styled-content style=\"fixed-case\">TNPT<\/jats:styled-content> compared with placebo. The risk\u2013benefit ratio favours 20 000 <jats:styled-content style=\"fixed-case\">AU<\/jats:styled-content>eq\/ml and 50 000 <jats:styled-content style=\"fixed-case\">AU<\/jats:styled-content>eq\/ml strengths for further clinical development.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.12860","type":"journal-article","created":{"date-parts":[[2016,2,11]],"date-time":"2016-02-11T04:13:46Z","timestamp":1455164026000},"page":"967-976","source":"Crossref","is-referenced-by-count":45,"title":["A randomized, 5\u2010arm dose finding study with a mite allergoid <scp>SCIT<\/scp> in allergic rhinoconjunctivitis patients"],"prefix":"10.1111","volume":"71","author":[{"given":"O.","family":"Pfaar","sequence":"first","affiliation":[{"name":"Center for Rhinology and Allergology Wiesbaden Germany"},{"name":"Department of Otorhinolaryngology Head and Neck Surgery Universit\u00e4tsmedizin Mannheim Medical Faculty Mannheim Heidelberg University Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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