{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T19:06:00Z","timestamp":1778785560314,"version":"3.51.4"},"reference-count":35,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,12,22]],"date-time":"2017-12-22T00:00:00Z","timestamp":1513900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"ASIT biotech s.a., Brussels, Belgium"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Allergy"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>A novel subcutaneous allergen immunotherapy formulation (gpASIT+\u2122) containing <jats:italic>Lolium perenne<\/jats:italic> peptides (LPP) and having a short up\u2010dosing phase has been developed to treat grass pollen\u2013induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective, double\u2010blind, placebo\u2010controlled, phase IIb, parallel, four\u2010arm, dose\u2010finding study randomized 198 grass pollen\u2013allergic adults to receive placebo or cumulative doses of 70, 170 or 370 \u03bcg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen\u2013specific immunoglobulins were analysed before and after treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Conjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 \u03bcg; <jats:italic>P<\/jats:italic> = .023), 46.3% (370 \u03bcg), and 38.6% (70 \u03bcg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per\u2010protocol set). Also, 39% of patients in the 170\u2010\u03bcg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen\u2010binding assays revealed a highly significant (<jats:italic>P<\/jats:italic> &lt; .001) dose\u2010dependent reduction in IgE allergen binding across all treatment groups (70 \u03bcg: 17.1%; 170 \u03bcg: 18.8%; 370 \u03bcg: 26.4%). Specific IgG<jats:sub>4<\/jats:sub> levels increased to 1.6\u2010fold (70 \u03bcg), 3.1\u2010fold (170 \u03bcg) and 3.9\u2010fold (370 \u03bcg) (mPP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Three\u2010week immunotherapy with 170 \u03bcg LPP reduced CPT reactivity significantly and increased protective specific antibodies.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.13358","type":"journal-article","created":{"date-parts":[[2017,11,18]],"date-time":"2017-11-18T07:22:40Z","timestamp":1510989760000},"page":"896-904","source":"Crossref","is-referenced-by-count":33,"title":["A randomized, double\u2010blind, placebo\u2010controlled, dose\u2010finding trial with <i>Lolium perenne<\/i> peptide immunotherapy"],"prefix":"10.1111","volume":"73","author":[{"given":"R.","family":"M\u00f6sges","sequence":"first","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"},{"name":"CRI \u2010 Clinical Research International Limited Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E. M.","family":"Kasche","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"},{"name":"University Hospital Schleswig\u2010Holstein L\u00fcbeck Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6461-8593","authenticated-orcid":false,"given":"E.","family":"Raskopf","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Singh","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Sohlich","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Astvatsatourov","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Shah\u2010Hosseini","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Pirotton","sequence":"additional","affiliation":[{"name":"ASIT Biotech s.a. Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Haazen","sequence":"additional","affiliation":[{"name":"ASIT Biotech s.a. Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. R.","family":"Durham","sequence":"additional","affiliation":[{"name":"Immunomodulation and Tolerance Group, Allergy &amp; Clinical Immunology Inflammation, Repair and Development National Heart &amp; Lung Institute  Imperial College London MRC &amp; Asthma UK Centre in Allergic Mechanisms of Asthma London United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Legon","sequence":"additional","affiliation":[{"name":"ASIT Biotech s.a. Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Zadoyan","sequence":"additional","affiliation":[{"name":"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE) Faculty of Medicine University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3425-3463","authenticated-orcid":false,"given":"M. H.","family":"Shamji","sequence":"additional","affiliation":[{"name":"Immunomodulation and Tolerance Group, Allergy &amp; Clinical Immunology Inflammation, Repair and Development National Heart &amp; Lung Institute  Imperial College London MRC &amp; Asthma UK Centre in Allergic Mechanisms of Asthma London United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,12,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2005.06.004"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12488"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/2045-7022-3-17"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2016.02.044"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11882-015-0587-0"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12128"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2008.03195.x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2003.1683"},{"key":"e_1_2_10_10_1","article-title":"Lolium perenne peptides for the treatment of grass pollen allergy: a randomized, double\u2010blind, placebo\u2010controlled clinical trial","author":"Shamji MH","year":"2017","journal-title":"J Allergy Clin Immunol"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40629-014-0009-1"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1159\/000068369"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1159\/000355333"},{"key":"e_1_2_10_14_1","first-page":"11","article-title":"Photodocumentation of Allergic Severity under Conjunctival Provocation","volume":"213","author":"Astvatsatourov A","year":"2015","journal-title":"Stud Health Technol Inform"},{"key":"e_1_2_10_15_1","first-page":"15","article-title":"Image\u2010Based Assessment of Allergic Inflammation under Conjunctival Provocation","volume":"213","author":"Astvatsatourov A","year":"2015","journal-title":"Stud Health Technol Inform"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2010.12.1080"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2011.02745.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.09.049"},{"key":"e_1_2_10_19_1","unstructured":"M\u00f6sgesR.Hydrolyzed grass pollen proteins for allergen immunotherapy. In: 14th International Paul\u2010Ehrlich\u2010Seminar Allergen Products for Diagnosis and Therapy: Regulation and Science;2014;Bad Nauheim Germany: Paul\u2010Ehrlich\u2010Institute; 2014. p.12."},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2014.10.015"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12986"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2008.02995.x"},{"key":"e_1_2_10_23_1","first-page":"63","article-title":"Observational study of the safety of a cluster schedule for subcutaneous immunotherapy in a pediatric population","volume":"23","author":"Pe\u00f1as A","year":"2013","journal-title":"J Investig Allergol Clin Immunol"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2012.09.006"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13601-015-0070-y"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2010.24.3508"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2010.11.029"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2012.03971.x"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2007.02.015"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12913"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12241"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.12.1249"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.04.001"},{"key":"e_1_2_10_34_1","first-page":"CD001936","article-title":"Allergen injection immunotherapy for seasonal allergic rhinitis","author":"Calderon MA","year":"2007","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2005.11.014"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.03.034"}],"container-title":["Allergy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fall.13358","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/all.13358","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T09:05:21Z","timestamp":1695027921000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/all.13358"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12,22]]},"references-count":35,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2018,4]]}},"alternative-id":["10.1111\/all.13358"],"URL":"https:\/\/doi.org\/10.1111\/all.13358","archive":["Portico"],"relation":{},"ISSN":["0105-4538","1398-9995"],"issn-type":[{"value":"0105-4538","type":"print"},{"value":"1398-9995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12,22]]}}}