A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice

References

• Meltzer EO, Nathan R, Derebery J, et al. Sleep, quality of life, and productivity impact of nasal symptoms in the United States: findings from the Burden of Rhinitis in America survey. Allergy Asthma Proc. 2009;30(3):244–254.
   PubMed Web of Science ®Google Scholar
• Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007;28(1):3–9.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Gaugris S, Kocevar VS, et al. Increased risk of asthma attacks and emergency visits among asthma patients with allergic rhinitis: a subgroup analysis of the investigation of montelukast as a partner agent for complementary therapy [corrected]. Clin Exp Allergy. 2005;35(6):723–727.
   PubMed Web of Science ®Google Scholar
• Lee E, Lee SH, Kwon JW, et al. A rhinitis phenotype associated with increased development of bronchial hyperresponsiveness and asthma in children. Ann Allergy Asthma Immunol. 2016;117(1):21–28.e21.
   PubMed Web of Science ®Google Scholar
• Cho SH, Lin HC, Ghoshal AG, et al. Respiratory disease in the Asia-Pacific region: cough as a key symptom. Allergy Asthma Proc. 2016;37(2):131–140.
   PubMed Web of Science ®Google Scholar
• Price D, Zhang Q, Kocevar VS, et al. Effect of a concomitant diagnosis of allergic rhinitis on asthma-related health care use by adults. Clin Exp Allergy. 2005;35(3):282–287.
   PubMed Web of Science ®Google Scholar
• Thomas M, Kocevar VS, Zhang Q, et al. Asthma-related health care resource use among asthmatic children with and without concomitant allergic rhinitis. Pediatrics. 2005;115(1):129–134.
   PubMed Web of Science ®Google Scholar
• Baena-Cagnani CE, Berger WE, DuBuske LM, et al. Comparative effects of desloratadine versus montelukast on asthma symptoms and use of beta 2-agonists in patients with seasonal allergic rhinitis and asthma. Int Arch Allergy Immunol. 2003;130(4):307–313.
   PubMed Web of Science ®Google Scholar
• Corren J, Adinoff AD, Buchmeier AD, et al. Nasal beclomethasone prevents the seasonal increase in bronchial responsiveness in patients with allergic rhinitis and asthma. J Allergy Clin Immunol. 1992;90(2):250–256.
   PubMed Web of Science ®Google Scholar
• Corren J, Harris AG, Aaronson D, et al. Efficacy and safety of loratadine plus pseudoephedrine in patients with seasonal allergic rhinitis and mild asthma. J Allergy Clin Immunol. 1997;100(6 Pt 1):781–788.
   PubMed Web of Science ®Google Scholar
• Foresi A, Pelucchi A, Gherson G, et al. Once daily intranasal fluticasone propionate (200 micrograms) reduces nasal symptoms and inflammation but also attenuates the increase in bronchial responsiveness during the pollen season in allergic rhinitis. J Allergy Clin Immunol. 1996;98(2):274–282.
   PubMed Web of Science ®Google Scholar
• Spector SL, Nicodemus CF, Corren J, et al. Comparison of the bronchodilatory effects of cetirizine, albuterol, and both together versus placebo in patients with mild-to-moderate asthma. J Allergy Clin Immunol. 1995;96(2):174–181.
   PubMed Web of Science ®Google Scholar
• Watson WT, Becker AB, Simons FE. Treatment of allergic rhinitis with intranasal corticosteroids in patients with mild asthma: effect on lower airway responsiveness. J Allergy Clin Immunol. 1993;91(1 Pt 1):97–101.
   PubMed Web of Science ®Google Scholar
• Didier A, Malling HJ, Worm M, et al. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015;5:12.
   PubMed Web of Science ®Google Scholar
• Durham SR, Emminger W, Kapp A, et al. SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. J Allergy Clin Immunol. 2012;129(3):717–725 e715.
   PubMed Web of Science ®Google Scholar
• Durham SR, Walker SM, Varga EM, et al. Long-term clinical efficacy of grass-pollen immunotherapy. N Engl J Med. 1999;341(7):468–475.
   PubMed Web of Science ®Google Scholar
• Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. 2011;127(1 Suppl):S1–55.
   PubMed Web of Science ®Google Scholar
• Donahue JG, Greineder DK, Connor-Lacke L, et al. Utilization and cost of immunotherapy for allergic asthma and rhinitis. Ann Allergy Asthma Immunol. 1999;82(4):339–347.
   PubMed Web of Science ®Google Scholar
• Hsu NM, Reisacher WR. A comparison of attrition rates in patients undergoing sublingual immunotherapy vs subcutaneous immunotherapy. Int Forum Allergy Rhinol. 2012;2(4):280–284.
   PubMed Web of Science ®Google Scholar
• Hankin CS, Cox L, Lang D, et al. Allergy immunotherapy among Medicaid-enrolled children with allergic rhinitis: patterns of care, resource use, and costs. J Allergy Clin Immunol. 2008;121(1):227–232.
   PubMed Web of Science ®Google Scholar
• Meltzer EO, Blaiss MS, Naclerio RM, et al. Burden of allergic rhinitis: allergies in America, Latin America, and Asia-Pacific adult surveys. Allergy Asthma Proc. 2012;33(Suppl 1):S113–141.
   PubMedGoogle Scholar
• Bergmann KC, Demoly P, Worm M, et al. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol. 2014;133(6):1608–1614.e1606.
   PubMed Web of Science ®Google Scholar
• Cox LS, Casale TB, Nayak AS, 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. 2012;130(6):1327–1334.
   PubMed Web of Science ®Google Scholar
• Creticos PS, Maloney J, Bernstein DI, et al. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013;131(5):1342–1349 e1346.
   PubMed Web of Science ®Google Scholar
• Dahl R, Kapp A, Colombo G, et al. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006;118(2):434–440.
   PubMed Web of Science ®Google Scholar
• Didier A, Malling HJ, Worm M, 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. 2007;120(6):1338–1345.
   PubMed Web of Science ®Google Scholar
• Maloney J, Bernstein DI, Nelson H, et al. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014;112(2):146–153.e142.
   PubMed Web of Science ®Google Scholar
• Nelson HS, Nolte H, Creticos P, et al. Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. J Allergy Clin Immunol. 2011;127(1):72–80 e72.
   PubMed Web of Science ®Google Scholar
• Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite SLIT-tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016;138(6):1631–1638.
   PubMed Web of Science ®Google Scholar
• Nolte H, Hebert J, Berman G, et al. Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults. Ann Allergy Asthma Immunol. 2013;110(6):450–456 e454.
   PubMed Web of Science ®Google Scholar
• Nolte H, Maloney J, Nelson HS, et al. Onset and dose-related efficacy of house dust mite sublingual immunotherapy tablets in an environmental exposure chamber. J Allergy Clin Immunol. 2015;135(6):1494–1501 e1496.
   PubMed Web of Science ®Google Scholar
• Ragwitek (short ragweed pollen allergen extract tablet for sublingual use). Full Prescribing Information. Whitehouse Station, NJ, USA: Merck Sharp & Dohme Corp; 2014.
   Google Scholar
• Grastek (Timothy grass pollen allergen extract tablet for sublingual use). Full Prescribing Information. Whitehouse Station, NJ, USA: Merck Sharp & Dohme Corp; 2014.
   Google Scholar
• Oralair (Sweet vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract tablet for sublingual use). Full Prescribing Information. Antony, France: Stallergenes S.A; 2014.
   Google Scholar
• Virchow JC, Backer V, Kuna P, et al. Efficacy of a house dust mite sublingual allergen immunotherapy tablet in adults with allergic asthma: a randomized clinical trial. JAMA. 2016;315(16):1715–1725.
   PubMed Web of Science ®Google Scholar
• Amin HS, Liss GM, Bernstein DI. Evaluation of near-fatal reactions to allergen immunotherapy injections. J Allergy Clin Immunol. 2006;117(1):169–175.
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Wanner M, Borish L, et al. Twelve-year survey of fatal reactions to allergen injections and skin testing: 1990-2001. J Allergy Clin Immunol. 2004;113(6):1129–1136.
   PubMed Web of Science ®Google Scholar
• Epstein TG, Liss GM, Murphy-Berendts K, et al. AAAAI/ACAAI surveillance study of subcutaneous immunotherapy, years 2008-2012: an update on fatal and nonfatal systemic allergic reactions. J Allergy Clin Immunol Pract. 2014;2(2):161–167.
   PubMed Web of Science ®Google Scholar
• Durham SR, Penagos M. Sublingual or subcutaneous immunotherapy for allergic rhinitis? J Allergy Clin Immunol. 2016;137(2):339–349.e310.
   PubMed Web of Science ®Google Scholar
• Blaiss M, Maloney J, Nolte H, et al. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011;127(1):64–71 e64.
   PubMed Web of Science ®Google Scholar
• Bufe A, Eberle P, Franke-Beckmann E, et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009;123(1):167–173 e167.
   PubMed Web of Science ®Google Scholar
• Dahl R, Stender A, Rak S. Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis. Allergy. 2006;61(2):185–190.
   PubMed Web of Science ®Google Scholar
• Durham SR, Yang WH, Pedersen MR, et al. Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006;117(4):802–809.
   PubMed Web of Science ®Google Scholar
• Murphy K, Gawchik S, Bernstein D, et al. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013;12(1):10.
   PubMedGoogle Scholar
• Nolte H, Amar N, Bernstein DI, et al. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014;113(1):93–100 e103.
   PubMed Web of Science ®Google Scholar
• Demoly P, Emminger W, Rehm D, et al. Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: results from a randomized double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2016;137(2):444–451.
   PubMed Web of Science ®Google Scholar
• “Data on File”. Tokyo, Japan: Torii Pharmaceutical Co., Ltd.
   Google Scholar
• Okubo K, Masuyama K, Imai T, et al. Efficacy and safety of the SQ house dust mite SLIT-tablet in Japanese adults and adolescents with house dust mite-induced allergic rhinitis: a randomized, double-blind, placebo-controlled study. J Allergy Clin Immunol. 2017. Forthcoming.
   PubMed Web of Science ®Google Scholar
• Calderon M, Essendrop M. Specific immunotherapy with high dose SO standardized grass allergen tablets was safe and well tolerated. J Investig Allergol Clin Immunol. 2006;16(6):338–344.
   PubMed Web of Science ®Google Scholar
• Nayak AS, Atiee GJ, Dige E, et al. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012;33(5):404–410.
   PubMed Web of Science ®Google Scholar
• Scadding G, Durham S. Mechanisms of sublingual immunotherapy. J Asthma. 2009;46(4):322–334.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Khaltaev N, Cruz AA, 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. 2008;63(suppl 86):8–160.
   PubMed Web of Science ®Google Scholar
• Passalacqua G, Baena-Cagnani CE, Bousquet J, et al. Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language. J Allergy Clin Immunol. 2013;132(1):93–98.
   PubMed Web of Science ®Google Scholar
• Cox LS, Sanchez-Borges M, Lockey RF. World allergy organization systemic allergic reaction grading system: is a modification needed? J Allergy Clin Immunol Pract. 2017;5(1):58–62.e55.
   PubMed Web of Science ®Google Scholar
• Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and management of anaphylaxis: summary report – second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117(2):391–397.
   PubMedGoogle Scholar
• Didier A, Bons B. Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review. Expert Opin Drug Saf. 2015;14(5):777–788.
   PubMed Web of Science ®Google Scholar
• Larenas-Linnemann D. How does the efficacy and safety of Oralair((R)) compare to other products on the market? Ther Clin Risk Manag. 2016;12:831–850.
   PubMed Web of Science ®Google Scholar
• Okamoto Y, Fujieda S, Okano M, et al. House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis. Allergy. 2017;72(3):435–443.
   PubMed Web of Science ®Google Scholar
• Gidaro GB, Marcucci F, Sensi L, et al. The safety of sublingual-swallow immunotherapy: an analysis of published studies. Clin Exp Allergy. 2005;35(5):565–571.
   PubMed Web of Science ®Google Scholar
• Nolte H, Casale TB, Lockey RF, et al. Epinephrine use in clinical trials of sublingual immunotherapy tablets. J Allergy Clin Immunol: In Practice. 2017;5(1):84–89.
   PubMed Web of Science ®Google Scholar