Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis

Journal of Allergy and Clinical Immunology

Volumn 133, Issue 3, 2014, Pages 751-758

  Creticos, Peter S ^a   Esch, Robert E ^b   Couroux, Peter ^c   Gentile, Deborah ^d   D'Angelo, Pina ^e   Whitlow, Brad ^b   Alexander, Michael ^f   Coyne, Terrance C ^b  

^a Creticos Research Group   (United States)

^b Greer Laboratories   (United States)

^c Topstone Research   (Canada)

^d ALLEGHENY GENERAL HOSPITAL   (United States)

^e Novum Pharmaceutical Research Services   (United States)

^f Niagara Clinical Research   (Canada)

Author keywords

Allergen specific IgE; allergen specific IgG4; allergy immunotherapy; combined score; ragweed; specific immunotherapy; sublingual immunotherapy

Indexed keywords

ALLERGEN; PLACEBO; PLANT EXTRACT; RAGWEED EXTRACT; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ALLERGIC RHINOCONJUNCTIVITIS; APPLICATION SITE REACTION; ARTICLE; ASTHMA; BACKACHE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DYSPEPSIA; EAR DISEASE; EDEMA; ERYTHEMA; HEADACHE; HUMAN; LIQUID; MAJOR CLINICAL STUDY; MIDDLE AGED; MUSCLE STRAIN; NORTH AMERICA; NOSE OBSTRUCTION; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RAGWEED POLLEN; RANDOMIZED CONTROLLED TRIAL; RHINOCONJUNCTIVITIS; RHINOPHARYNGITIS; SCORING SYSTEM; SINUS CONGESTION; SKIN DISEASE; SUBLINGUAL IMMUNOTHERAPY; SWELLING; UPPER RESPIRATORY TRACT INFECTION; YOUNG ADULT;

ALLERGEN-SPECIFIC IGE; ALLERGEN-SPECIFIC IGG(4); ALLERGY IMMUNOTHERAPY; COMBINED SCORE; RAGWEED; SPECIFIC IMMUNOTHERAPY; SUBLINGUAL IMMUNOTHERAPY;

ADULT; ANTIGENS, PLANT; CONJUNCTIVITIS, ALLERGIC; DESENSITIZATION, IMMUNOLOGIC; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; PLANT EXTRACTS; RHINITIS, ALLERGIC, PERENNIAL;

EID: 84896735209     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2013.10.041     Document Type: Article

References (35)

1. L. Cox, H. Nelson, R. Lockey, C. Calabria, T. Chacko, and I. Finegold et al. Allergen immunotherapy: a practice parameter third update J Allergy Clin Immunol 127 2011 S1 S55
2. S.S. Mohapatra, M. Qazi, and G. Hellermann Immunotherapy for allergies and asthma: present and future Curr Opin Pharmacol 10 2010 276 288
3. N.M. Hsu, and W.R. Reisacher A comparison of attrition rates in patients undergoing sublingual immunotherapy vs subcutaneous immunotherapy Int Forum Allergy Rhinol 2 2012 280 284
4. G.W. Canonica, J. Bousquet, T. Casale, R.F. Lockey, C.E. Baena-Cagnani, and R. Pawankar et al. Sub-lingual immunotherapy: World Allergy Organization Position Paper 2009 Allergy 64 2009 1 59
5. Creticos PS. Oral and sublingual immunotherapy for allergic rhinitis. Wolters Kluwer Health. Available from: http://www.uptodate.com/contents/ sublingual-and-oral-immunotherapy-for-allergic-rhinitis. Accessed April 5, 2013.
6. S.Y. Lin, N. Erekosima, J.M. Kim, M. Ramanathan, C. Suarez-Cuervo, and Y. Chelladurai et al. Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis and asthma: a systematic review JAMA 309 2013 1278 1288
7. S. Radulovic, D. Wilson, M. Calderon, and S. Durham Systematic reviews of sublingual immunotherapy (SLIT) Allergy 66 2011 740 752
8. R.S. Swamy, N. Reshamwala, T. Hunter, S. Vissamsetti, C.B. Santos, and F.M. Baroody et al. Epigenetic modifications and improved regulatory T-cell function in subjects undergoing dual sublingual immunotherapy J Allergy Clin Immunol 130 2012 215 224
9. S.M. Amar, R.J. Harbeck, M. Sills, L.J. Silveira, H. O'Brien, and H.S. Nelson Response to sublingual immunotherapy with grass pollen extract: monotherapy versus combination in a multiallergen extract J Allergy Clin Immunol 124 2009 150 156
10. H.S. Nelson, J. Oppenheimer, G.A. Vatsia, and A. Buchmeier A double-blind, placebo-controlled evaluation of sublingual immunotherapy with standardized cat extract J Allergy Clin Immunol 92 1993 229 236
11. D. Skoner, D. Gentile, R. Bush, M.B. Fasano, A. McLaughlin, and R.E. Esch Sublingual immunotherapy in patients with allergic rhinoconjunctivitis caused by ragweed pollen J Allergy Clin Immunol 125 2010 660 666
12. R.K. Bush, C. Swenson, B. Fahlberg, M.D. Evans, R. Esch, and M. Morris et al. House dust mite sublingual immunotherapy: results of a US trial J Allergy Clin Immunol 127 2011 974 981
13. R.E. Esch, R.K. Bush, D. Peden, and R.F. Lockey Sublingual-oral administration of standardized allergenic extracts: phase 1 safety and dosing results Ann Allergy Asthma Immunol 100 2008 475 481
14. S.J. Arbes Jr., P.J. Gergen, L. Elliott, and D.C. Zeldin Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey J Allergy Clin Immunol 116 2005 377 383
15. M. Blaiss, J. Maloney, H. Nolte, S. Gawchik, R. Yao, and D.P. Skoner Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents J Allergy Clin Immunol 127 2011 64 71
16. L.S. Cox, T.B. Casale, A.S. Nayak, D.I. Bernstein, P.S. Creticos, and L. Ambroisine et al. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE J Allergy Clin Immunol 130 2012 1327 1334
17. D. Di Bona, A. Plaia, M.S. Leto-Barone, S. La Piana, and G. Di Lorenzo Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: a meta-analysis-based comparison J Allergy Clin Immunol 130 2012 1097 1107
18. H.S. Nelson, H. Nolte, P. Creticos, J. Maloney, J. Wu, and D.I. Bernstein Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults J Allergy Clin Immunol 127 2011 72 80
19. P.S. Creticos, J. Maloney, D.I. Bernstein, T. Casale, A. Kaur, and R. Fisher et al. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults J Allergy Clin Immunol 131 2013 1342 1349
20. C. Andre, M. Perrin-Fayolle, M. Grosclaude, P. Couturier, D. Basset, and J. Cornillon et al. A double-blind placebo-controlled evaluation of sublingual immunotherapy with a standardized ragweed extract in patients with seasonal rhinitis. Evidence for a dose-response relationship Int Arch Allergy Immunol 131 2003 111 118
21. T. Bowen, J. Greenbaum, Y. Charbonneau, J. Hebert, R. Filderman, and G. Sussman et al. Canadian trial of sublingual swallow immunotherapy for ragweed rhinoconjunctivitis Ann Allergy Asthma Immunol 93 2004 425 430
22. N.N. Bahceciler, and N. Galip Comparing subcutaneous and sublingual immunotherapy: what do we know? Curr Opin Allergy Clin Immunol 12 2012 640 647
23. U. Wahn, L. Klimek, A. Ploszczuk, T. Adelt, B. Sandner, and E. Trebas-Pietras et al. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study J Allergy Clin Immunol 130 2012 886 893
24. H. Nolte, J. Hébert, G. Berman, S. Gawchik, M. White, and A. Kaur et al. Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults Ann Allergy Asthma Immunol 110 2013 450 456
25. R. Dahl, A. Kapp, G. Colombo, J.G. de Monchy, S. Rak, and W. Emminger et al. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis J Allergy Clin Immunol 118 2006 434 440
26. A. Didier, H.J. Malling, M. Worm, F. Horak, S. Jager, and A. Montagut et al. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis J Allergy Clin Immunol 120 2007 1338 1345
27. G.W. Canonica, C.E. Baena-Cagnani, J. Bousquet, P.J. Bousquet, R.F. Lockey, and H.J. Malling et al. Recommendations for standardization of clinical trials with allergen specific immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce Allergy 62 2007 317 324
28. T.B. Casale, G.W. Canonica, J. Bousquet, L. Cox, R. Lockey, and H.S. Nelson et al. Recommendations for appropriate sublingual immunotherapy clinical trials J Allergy Clin Immunol 124 2009 665 670
29. P.S. Creticos, T.E. Van Metre, M.R. Mardiney, G.L. Rosenberg, P.S. Norman, and N.F. Adkinson Jr. Dose response of IgE and IgG antibodies during ragweed immunotherapy J Allergy Clin Immunol 73 1984 94 104
30. G.J. Gleich, E.M. Zimmermann, L.L. Henderson, and J.W. Yunginger Effect of immunotherapy on immunoglobulin E and immunoglobulin G antibodies to ragweed antigens: a six-year prospective study J Allergy Clin Immunol 70 1982 261 271
31. G.W. Scadding, M.H. Shamji, M.R. Jacobson, D.I. Lee, D. Wilson, and M.T. Lima et al. Sublingual grass pollen immunotherapy is associated with increases in sublingual Foxp3-expressing cells and elevated allergen-specific immunoglobulin G4, immunoglobulin A and serum inhibitory activity for immunoglobulin E-facilitated allergen binding to B cells Clin Exp Allergy 40 2010 598 606
32. H.J. Malling, L. Lund, H. Ipsen, and L. Poulsen Safety and immunological changes during sublingual immunotherapy with standardized quality grass allergen tablets J Investig Allergol Clin Immunol 16 2006 162 168
33. O. Pfaar, and L. Klimek Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial Ann Allergy Asthma Immunol 100 2008 256 263
34. A. Bufe, P. Eberle, E. Franke-Beckmann, J. Funck, M. Kimmig, and L. Klimek et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy J Allergy Clin Immunol 123 2009 167 173
35. J. Bousquet, N. Khaltaev, A.A. Cruz, J. Denburg, W.J. Fokkens, and A. Togias et al. Allergic Rhinitis and Its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen) Allergy 63 2008 8 160