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Grass pollen sublingual immunotherapy for seasonal rhinoconjunctivitis: a randomized controlled trial

Summary Background Previous studies suggest that sublingual immunotherapy (SLIT) represents a safer alternative to injection immunotherapy but equivalent efficacy is yet to be confirmed. Objective To evaluate the efficacy and safety of SLIT in grass pollen‐induced seasonal rhinoconjunctivitis. Metho...

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Published in:Clinical and experimental allergy 2002-04, Vol.32 (4), p.507-514
Main Authors: Lima, M. Torres, Wilson, D., Pitkin, L., Roberts, A., Nouri-Aria, K., Jacobson, M., Walker, S., Durham, S.
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container_title Clinical and experimental allergy
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creator Lima, M. Torres
Wilson, D.
Pitkin, L.
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Jacobson, M.
Walker, S.
Durham, S.
description Summary Background Previous studies suggest that sublingual immunotherapy (SLIT) represents a safer alternative to injection immunotherapy but equivalent efficacy is yet to be confirmed. Objective To evaluate the efficacy and safety of SLIT in grass pollen‐induced seasonal rhinoconjunctivitis. Methods A randomized, placebo‐controlled trial in 56 adults over 18 months. Outcome measures included diary scores of seasonal symptoms and medication use, overall assessments, conjunctival and intradermal provocation tests and serum antibody measurements. To investigate possible mechanisms, sublingual biopsies were taken for measurement of local T cells, antigen‐presenting cells and IL‐12 mRNA expression. Results There were no significant differences between the immunotherapy (IT) and placebo groups for diary symptom scores (P = 0.48) or rescue medication (P = 0.19). The patients' overall assessment of hayfever severity compared with previous years showed a highly significant improvement in favour of the IT group (P 
doi_str_mv 10.1046/j.0954-7894.2002.01327.x
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Torres ; Wilson, D. ; Pitkin, L. ; Roberts, A. ; Nouri-Aria, K. ; Jacobson, M. ; Walker, S. ; Durham, S.</creator><creatorcontrib>Lima, M. Torres ; Wilson, D. ; Pitkin, L. ; Roberts, A. ; Nouri-Aria, K. ; Jacobson, M. ; Walker, S. ; Durham, S.</creatorcontrib><description>Summary Background Previous studies suggest that sublingual immunotherapy (SLIT) represents a safer alternative to injection immunotherapy but equivalent efficacy is yet to be confirmed. Objective To evaluate the efficacy and safety of SLIT in grass pollen‐induced seasonal rhinoconjunctivitis. Methods A randomized, placebo‐controlled trial in 56 adults over 18 months. Outcome measures included diary scores of seasonal symptoms and medication use, overall assessments, conjunctival and intradermal provocation tests and serum antibody measurements. To investigate possible mechanisms, sublingual biopsies were taken for measurement of local T cells, antigen‐presenting cells and IL‐12 mRNA expression. Results There were no significant differences between the immunotherapy (IT) and placebo groups for diary symptom scores (P = 0.48) or rescue medication (P = 0.19). The patients' overall assessment of hayfever severity compared with previous years showed a highly significant improvement in favour of the IT group (P &lt; 0.02). After treatment the late skin response was smaller (P = 0.003) and the ratio of serum allergen‐specific IgG4/IgE was higher (P = 0.05) in the IT group. Both of these variables correlated with the clinical response to SLIT. There were no differences between groups in either the sublingual epithelium or lamina propria for numbers of CD3+ cells (epithelium: P = 0.9, lamina propria: P = 0.2), CD1a+ cells (P = 0.3, P = 0.25), CD68+ cells (P = 0.9, P = 1.0) or IL‐12 mRNA+ cells (P = 0.6, P = 0.4). Local side‐effects were minor and there were no serious treatment‐related adverse events. Conclusion Grass pollen sublingual immunotherapy was well tolerated. Although there was no significant change in diary scores, the improvement in overall assessments, which correlated with inhibition of the late skin response and increases in serum IgG4 : IgE ratio, indicates the need for larger, dose‐ranging studies.</description><identifier>ISSN: 0954-7894</identifier><identifier>EISSN: 1365-2222</identifier><identifier>DOI: 10.1046/j.0954-7894.2002.01327.x</identifier><identifier>PMID: 11972594</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Administration, Sublingual ; Adult ; Allergens - therapeutic use ; antibodies ; Antigens, CD1 - analysis ; Antigens, CD1 - immunology ; Biological and medical sciences ; CD3 Complex - analysis ; CD3 Complex - immunology ; Conjunctivitis, Allergic - diagnosis ; Conjunctivitis, Allergic - immunology ; Conjunctivitis, Allergic - therapy ; cytokines ; Double-Blind Method ; Female ; hayfever ; Humans ; Immunoglobulin E - blood ; Immunoglobulin G - blood ; Immunohistochemistry ; Immunopathology ; immunotherapy ; Immunotherapy (general aspects) ; Interleukin-12 - biosynthesis ; Interleukin-12 - genetics ; Male ; Medical sciences ; Middle Aged ; Mouth Mucosa - cytology ; Mouth Mucosa - metabolism ; Poaceae - immunology ; Pollen - immunology ; Rhinitis, Allergic, Seasonal - diagnosis ; Rhinitis, Allergic, Seasonal - immunology ; Rhinitis, Allergic, Seasonal - therapy ; rhinoconjunctivitis ; RNA, Messenger - biosynthesis ; sublingual</subject><ispartof>Clinical and experimental allergy, 2002-04, Vol.32 (4), p.507-514</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright Blackwell Scientific Publications Ltd. Apr 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5577-2ccc017043c2a7511bbfb3a4b9fa32633934c1e58e3ddac38f9e662b2d5567143</citedby><cites>FETCH-LOGICAL-c5577-2ccc017043c2a7511bbfb3a4b9fa32633934c1e58e3ddac38f9e662b2d5567143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=13822978$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11972594$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lima, M. Torres</creatorcontrib><creatorcontrib>Wilson, D.</creatorcontrib><creatorcontrib>Pitkin, L.</creatorcontrib><creatorcontrib>Roberts, A.</creatorcontrib><creatorcontrib>Nouri-Aria, K.</creatorcontrib><creatorcontrib>Jacobson, M.</creatorcontrib><creatorcontrib>Walker, S.</creatorcontrib><creatorcontrib>Durham, S.</creatorcontrib><title>Grass pollen sublingual immunotherapy for seasonal rhinoconjunctivitis: a randomized controlled trial</title><title>Clinical and experimental allergy</title><addtitle>Clin Exp Allergy</addtitle><description>Summary Background Previous studies suggest that sublingual immunotherapy (SLIT) represents a safer alternative to injection immunotherapy but equivalent efficacy is yet to be confirmed. Objective To evaluate the efficacy and safety of SLIT in grass pollen‐induced seasonal rhinoconjunctivitis. Methods A randomized, placebo‐controlled trial in 56 adults over 18 months. Outcome measures included diary scores of seasonal symptoms and medication use, overall assessments, conjunctival and intradermal provocation tests and serum antibody measurements. To investigate possible mechanisms, sublingual biopsies were taken for measurement of local T cells, antigen‐presenting cells and IL‐12 mRNA expression. Results There were no significant differences between the immunotherapy (IT) and placebo groups for diary symptom scores (P = 0.48) or rescue medication (P = 0.19). The patients' overall assessment of hayfever severity compared with previous years showed a highly significant improvement in favour of the IT group (P &lt; 0.02). After treatment the late skin response was smaller (P = 0.003) and the ratio of serum allergen‐specific IgG4/IgE was higher (P = 0.05) in the IT group. Both of these variables correlated with the clinical response to SLIT. There were no differences between groups in either the sublingual epithelium or lamina propria for numbers of CD3+ cells (epithelium: P = 0.9, lamina propria: P = 0.2), CD1a+ cells (P = 0.3, P = 0.25), CD68+ cells (P = 0.9, P = 1.0) or IL‐12 mRNA+ cells (P = 0.6, P = 0.4). Local side‐effects were minor and there were no serious treatment‐related adverse events. Conclusion Grass pollen sublingual immunotherapy was well tolerated. 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Torres ; Wilson, D. ; Pitkin, L. ; Roberts, A. ; Nouri-Aria, K. ; Jacobson, M. ; Walker, S. ; Durham, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5577-2ccc017043c2a7511bbfb3a4b9fa32633934c1e58e3ddac38f9e662b2d5567143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Administration, Sublingual</topic><topic>Adult</topic><topic>Allergens - therapeutic use</topic><topic>antibodies</topic><topic>Antigens, CD1 - analysis</topic><topic>Antigens, CD1 - immunology</topic><topic>Biological and medical sciences</topic><topic>CD3 Complex - analysis</topic><topic>CD3 Complex - immunology</topic><topic>Conjunctivitis, Allergic - diagnosis</topic><topic>Conjunctivitis, Allergic - immunology</topic><topic>Conjunctivitis, Allergic - therapy</topic><topic>cytokines</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>hayfever</topic><topic>Humans</topic><topic>Immunoglobulin E - blood</topic><topic>Immunoglobulin G - blood</topic><topic>Immunohistochemistry</topic><topic>Immunopathology</topic><topic>immunotherapy</topic><topic>Immunotherapy (general aspects)</topic><topic>Interleukin-12 - biosynthesis</topic><topic>Interleukin-12 - genetics</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mouth Mucosa - cytology</topic><topic>Mouth Mucosa - metabolism</topic><topic>Poaceae - immunology</topic><topic>Pollen - immunology</topic><topic>Rhinitis, Allergic, Seasonal - diagnosis</topic><topic>Rhinitis, Allergic, Seasonal - immunology</topic><topic>Rhinitis, Allergic, Seasonal - therapy</topic><topic>rhinoconjunctivitis</topic><topic>RNA, Messenger - biosynthesis</topic><topic>sublingual</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lima, M. Torres</creatorcontrib><creatorcontrib>Wilson, D.</creatorcontrib><creatorcontrib>Pitkin, L.</creatorcontrib><creatorcontrib>Roberts, A.</creatorcontrib><creatorcontrib>Nouri-Aria, K.</creatorcontrib><creatorcontrib>Jacobson, M.</creatorcontrib><creatorcontrib>Walker, S.</creatorcontrib><creatorcontrib>Durham, S.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical and experimental allergy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lima, M. Torres</au><au>Wilson, D.</au><au>Pitkin, L.</au><au>Roberts, A.</au><au>Nouri-Aria, K.</au><au>Jacobson, M.</au><au>Walker, S.</au><au>Durham, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Grass pollen sublingual immunotherapy for seasonal rhinoconjunctivitis: a randomized controlled trial</atitle><jtitle>Clinical and experimental allergy</jtitle><addtitle>Clin Exp Allergy</addtitle><date>2002-04</date><risdate>2002</risdate><volume>32</volume><issue>4</issue><spage>507</spage><epage>514</epage><pages>507-514</pages><issn>0954-7894</issn><eissn>1365-2222</eissn><abstract>Summary Background Previous studies suggest that sublingual immunotherapy (SLIT) represents a safer alternative to injection immunotherapy but equivalent efficacy is yet to be confirmed. Objective To evaluate the efficacy and safety of SLIT in grass pollen‐induced seasonal rhinoconjunctivitis. Methods A randomized, placebo‐controlled trial in 56 adults over 18 months. Outcome measures included diary scores of seasonal symptoms and medication use, overall assessments, conjunctival and intradermal provocation tests and serum antibody measurements. To investigate possible mechanisms, sublingual biopsies were taken for measurement of local T cells, antigen‐presenting cells and IL‐12 mRNA expression. Results There were no significant differences between the immunotherapy (IT) and placebo groups for diary symptom scores (P = 0.48) or rescue medication (P = 0.19). The patients' overall assessment of hayfever severity compared with previous years showed a highly significant improvement in favour of the IT group (P &lt; 0.02). After treatment the late skin response was smaller (P = 0.003) and the ratio of serum allergen‐specific IgG4/IgE was higher (P = 0.05) in the IT group. Both of these variables correlated with the clinical response to SLIT. There were no differences between groups in either the sublingual epithelium or lamina propria for numbers of CD3+ cells (epithelium: P = 0.9, lamina propria: P = 0.2), CD1a+ cells (P = 0.3, P = 0.25), CD68+ cells (P = 0.9, P = 1.0) or IL‐12 mRNA+ cells (P = 0.6, P = 0.4). Local side‐effects were minor and there were no serious treatment‐related adverse events. Conclusion Grass pollen sublingual immunotherapy was well tolerated. Although there was no significant change in diary scores, the improvement in overall assessments, which correlated with inhibition of the late skin response and increases in serum IgG4 : IgE ratio, indicates the need for larger, dose‐ranging studies.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>11972594</pmid><doi>10.1046/j.0954-7894.2002.01327.x</doi><tpages>8</tpages></addata></record>
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subjects Administration, Sublingual
Adult
Allergens - therapeutic use
antibodies
Antigens, CD1 - analysis
Antigens, CD1 - immunology
Biological and medical sciences
CD3 Complex - analysis
CD3 Complex - immunology
Conjunctivitis, Allergic - diagnosis
Conjunctivitis, Allergic - immunology
Conjunctivitis, Allergic - therapy
cytokines
Double-Blind Method
Female
hayfever
Humans
Immunoglobulin E - blood
Immunoglobulin G - blood
Immunohistochemistry
Immunopathology
immunotherapy
Immunotherapy (general aspects)
Interleukin-12 - biosynthesis
Interleukin-12 - genetics
Male
Medical sciences
Middle Aged
Mouth Mucosa - cytology
Mouth Mucosa - metabolism
Poaceae - immunology
Pollen - immunology
Rhinitis, Allergic, Seasonal - diagnosis
Rhinitis, Allergic, Seasonal - immunology
Rhinitis, Allergic, Seasonal - therapy
rhinoconjunctivitis
RNA, Messenger - biosynthesis
sublingual
title Grass pollen sublingual immunotherapy for seasonal rhinoconjunctivitis: a randomized controlled trial
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