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Drug profile

300 IR HDM tablet: a sublingual immunotherapy tablet for the treatment of house dust mite-associated allergic rhinitis

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Pages 1141-1151 | Received 15 Jul 2016, Accepted 13 Sep 2016, Published online: 29 Sep 2016

References

  • Grabenhenrich LB, Keil T, Reich A, et al. Prediction and prevention of allergic rhinitis: a birth cohort study of 20 years. J Allergy Clin Immunol. 2015;136(4):932–40.e12.
  • Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on asthma (ARIA) 2008. Allergy. 2008;63(Suppl 86):8–160.
  • Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126(3):466–476.
  • Bjorksten B, Clayton T, Ellwood P, et al. Worldwide time trends for symptoms of rhinitis and conjunctivitis: phase III of the International Study of Asthma and Allergies in Childhood. Pediatr Allergy Immunol. 2008;19(2):110–124.
  • Canonica GW, Bousquet J, Mullol J, et al. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;62(Suppl 85):17–25.
  • Leger D, Annesi-Maesano I, Carat F, et al. Allergic rhinitis and its consequences on quality of sleep: an unexplored area. Arch Intern Med. 2006;166(16):1744–1748.
  • Nolte H, Nepper-Christensen S, Backer V. Unawareness and undertreatment of asthma and allergic rhinitis in a general population. Respir Med. 2006;100(2):354–362.
  • Valovirta E, Myrseth SE, Palkonen S. The voice of the patients: allergic rhinitis is not a trivial disease. Curr Opin Allergy Clin Immunol. 2008;8(1):1–9.
  • Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007;28(1):3–9.
  • Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011;106(2 Suppl):S12–16.
  • Zuberbier T, Lotvall J, Simoens S, et al. Economic burden of inadequate management of allergic diseases in the European Union: a GA2LEN review. Allergy. 2014;69(10):1275–1279.
  • Khan DA. Allergic rhinitis and asthma: epidemiology and common pathophysiology. Allergy Asthma Proc. 2014;35(5):357–361.
  • Shaaban R, Zureik M, Soussan D, et al. Rhinitis and onset of asthma: a longitudinal population-based study. Lancet. 2008;372(9643):1049–1057.
  • Calderon MA, Linneberg A, Kleine-Tebbe J, et al. Respiratory allergy caused by house dust mites: what do we really know? J Allergy Clin Immunol. 2015;136(1):38–48.
  • Eifan AO, Calderon MA, Durham SR. Allergen immunotherapy for house dust mite: clinical efficacy and immunological mechanisms in allergic rhinitis and asthma. Expert Opin Biol Ther. 2013;13(11):1543–1556.
  • Batard T, Baron-Bodo V, Martelet A, et al. Patterns of IgE sensitization in house dust mite-allergic patients: implications for allergen immunotherapy. Allergy. 2016;71(2):220–229.
  • Newson RB, Van Ree R, Forsberg B, et al. Geographical variation in the prevalence of sensitization to common aeroallergens in adults: the GA(2) LEN survey. Allergy. 2014;69(5):643–651.
  • Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004;24(5):758–764.
  • Melioli G, Marcomini L, Agazzi A, et al. The IgE repertoire in children and adolescents resolved at component level: a cross-sectional study. Pediatr Allergy Immunol. 2012;23(5):433–440.
  • Crisafulli D, Almqvist C, Marks G, et al. Seasonal trends in house dust mite allergen in children’s beds over a 7-year period. Allergy. 2007;62(12):1394–1400.
  • Gelardi M, Peroni DG, Incorvaia C, et al. Seasonal changes in nasal cytology in mite-allergic patients. J Inflamm Res. 2014;7:39–44.
  • Kosik-Bogacka DI, Kalisinska E, Henszel L, et al. Seasonal dynamics of house dust mites in dust samples collected from sleeping places in north-western Poland. Zoonoses Public Health. 2012;59(1):8–15.
  • Ciprandi G, Cirillo I, Klersy C, et al. Nasal obstruction is the key symptom in hay fever patients. Otolaryngol Head Neck Surg. 2005;133(3):429–435.
  • Sibbald B, Rink E. Epidemiology of seasonal and perennial rhinitis: clinical presentation and medical history. Thorax. 1991;46(12):895–901.
  • Custovic A, Sonntag HJ, Buchan IE, et al. Evolution pathways of IgE responses to grass and mite allergens throughout childhood. J Allergy Clin Immunol. 2015;136(6):1645-1652 e1641-1648.
  • Simpson A, Lazic N, Belgrave DC, et al. Patterns of IgE responses to multiple allergen components and clinical symptoms at age 11 years. J Allergy Clin Immunol. 2015;136(5):1224–1231.
  • Calderon MA, Kleine-Tebbe J, Linneberg A, et al. House dust mite respiratory allergy: an overview of current therapeutic strategies. J Allergy Clin Immunol Pract. 2015;3(6):843–855.
  • Biagtan M, Viswanathan R, Bush RK. Immunotherapy for house dust mite sensitivity: where are the knowledge gaps? Curr Allergy Asthma Rep. 2014;14(12):482.
  • Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010;8:Cd001186.
  • Calderon MA, Simons FE, Malling HJ, et al. Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile. Allergy. 2012;67(3):302–311.
  • Canonica GW, Cox L, Pawankar R, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J. 2014;7(1):6.
  • Kaul S, May S, Luttkopf D, et al. Regulatory environment for allergen-specific immunotherapy. Allergy. 2011;66(6):753–764.
  • Lyseng-Williamson KA. House dust mite sublingual tablets (Actair®): a guide to their use as allergy immunotherapy for house dust mite-induced allergic rhinitis. Drugs Ther Perspect. 2016;32(6):219–225.
  • 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.e8.
  • Klimek L, Mosbech H, Zieglmayer P, et al. SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitis. Expert Rev Clin Immunol. 2016;12(4):369–377.
  • Shionogi Co. Ltd. Actair® house dust mite 100 IR & 300 IR sublingual tablets: Japanese prescribing information. 2016.
  • Stallergenes Greer. Summary of Product Characteristics: Actair® 100 IR & 300 IR sublingual tablets. 2016 [cited 2016 Aug 14]. Available from: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&k=A
  • Calderon MA, Cox L, Casale TB, et al. The effect of a new communication template on anticipated willingness to initiate or resume allergen immunotherapy: an internet-based patient survey. Allergy Asthma Clin Immunol. 2015;11(1):17.
  • 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.
  • Okamoto Y, Fujieda S, Okano M, et al. House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis. Allergy. 2016. doi:10.1111/all.12996. [Epub ahead of print].
  • Pitsios C, Demoly P, Bilo MB, et al. Clinical contraindications to allergen immunotherapy: an EAACI position paper. Allergy. 2015;70(8):897–909.
  • Moingeon P. Progress in the development of specific immunotherapies for house dust mite allergies. Expert Rev Vaccines. 2014;13(12):1463–1473.
  • Chapman MD, Wunschmann S, Pomes A. Proteases as Th2 adjuvants. Curr Allergy Asthma Rep. 2007;7(5):363–367.
  • Trompette A, Divanovic S, Visintin A, et al. Allergenicity resulting from functional mimicry of a Toll-like receptor complex protein. Nature. 2009;457(7229):585–588.
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP), Guideline on Allergen Products: Production and Quality Issues (CHMP/BWP/304831/2007). 2007.
  • Batard T, Hrabina A, Bi XZ, et al. Production and proteomic characterization of pharmaceutical-grade Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts for allergy vaccines. Int Arch Allergy Immunol. 2006;140(4):295–305.
  • Moingeon P, Batard T, Nony E, et al. Quality control of house dust mite extracts for allergen immunotherapy. Int Arch Allergy Immunol. 2013;161(3):285–286.
  • Roux M, Devillier P, Yang WH, et al. Efficacy and safety of sublingual tablets of house dust mite allergen extracts: results of a dose-ranging study in an environmental exposure chamber. J Allergy Clin Immunol. 2016;138(2):451–458.e455.
  • Moingeon P. Update on immune mechanisms associated with sublingual immunotherapy: practical implications for the clinician. J Allergy Clin Immunol Pract. 2013;1(3):228–241.
  • Baron-Bodo V, Batard T, Nguyen H, et al. Absence of IgE neosensitization in house dust mite allergic patients following sublingual immunotherapy. Clin Exp Allergy. 2012;42(10):1510–1518.
  • Tourdot S, Airouche S, Berjont N, et al. Evaluation of therapeutic sublingual vaccines in a murine model of chronic house dust mite allergic airway inflammation. Clin Exp Allergy. 2011;41(12):1784–1792.
  • Canonica GW, Bousquet J, Casale T, et al. Sub-lingual immunotherapy: World Allergy Organization Position Paper 2009. Allergy. 2009;64(Suppl 91):1–59.
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP), Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases (CHMP/EWP/18504/2006). 2008.
  • Bagnasco M, Mariani G, Passalacqua G, et al. Absorption and distribution kinetics of the major Parietaria judaica allergen (Par j 1) administered by noninjectable routes in healthy human beings. J Allergy Clin Immunol. 1997;100(1):122–129.
  • Bagnasco M, Morbelli S, Altrinetti V, et al. Allergen biodistribution in humans. Chem Immunol Allergy. 2003;82:33–43.
  • Halken S, Wahn U, Mélac M, et al. Assessment of efficacy and safety of sublingual tablets of house dust mite allergen extract in children and adolescents with allergic rhinitis. Clin Transl Allergy. 2014;4(Suppl. 1):017.
  • Demoly P, Meziane L, Le Gall M, et al. Safety and tolerability of house dust mite tablets in sublingual immunotherapy. J Allergy Clin Immunol. 2008;121(2 (Suppl. 1)):S128.
  • Roux M, Patel P, Viatte A, et al. Safety of high doses of sublingual tablets of house dust mite allergen extracts in adolescents with allergic rhinitis. Allergy Eur J Allergy Clin Immunol. 2014;69:613.
  • Roux M, Kakudo S, Karagiannis E, et al. Efficacy of sublingual tablet of house dust mite allergen extracts in adolescents with house dust mite-associated allergic rhinitis. Presented at: 4th Pediatric Allergy and Asthma Meeting (PAAM); Berlin; 2015.
  • Okamoto Y, Masuyama K, Fujieda S, et al. House dust mite tablet (S-524101/STG320) at 300 IR is effective in both mono and poly-sensitized patients with allergic rhinitis in a Phase 2/3 study conducted in Japan. Presented at: European Academy of Allergy and Clinical Immunology Congress (EAACI) 2016; Vienna; 2016.
  • Parkes A, Abiteboul K. Treatment with house dust mite tablets for sublingual immunotherapy: relationship between allergic disease severity and efficacy in a confirmatory study. Intern Med J. 2016;46(S4):21.
  • Demoly PM, Bergmann KC, Khairallah S, et al. Safety of STG320 sublingual tablets of house dust mite allergen extracts in subjects with HDM-associated allergic rhinitis: results of a pooled analysis. J Allergy Clin Immunol. 2016;137(2 Suppl):AB403.
  • Parkes A, Cognet-Sicé J, Okamoto Y. Safety of 300IR sublingual tablet of house dust mite allergen extracts in adolescents with house dust mite-associated allergic rhinitis. Intern Med J. 2016;46(S4):20.
  • Demoly P, Passalacqua G, Calderon MA, et al. Choosing the optimal dose in sublingual immunotherapy: rationale for the 300 index of reactivity dose. Clin Transl Allergy. 2015;5:44.
  • Bahceciler NN, Babayigit Hocaoglu A, Galip N. A milestone in house dust-mite-allergen immunotherapy: the new sublingual tablet S-524101 (Actair). Expert Rev Vaccines. 2014;13(12):1427–1438.
  • Demoly P, Betting P, Le Gall M, et al. Tolérance d’un comprimé sublingual d’extraits allergéniques d’acariens chez l’adulte présentant un asthme allergique aux acariens. Presented at: 9e Congrès Francophone d’Allergologie (CFA); Paris; 2014.
  • Zeldin RK, Demoly P, Betting P, et al. Sublingual tablets of house dust mite allergen extracts: results of a Phase I study in adults with mite-associated allergic asthma. Eur Respir J. 2013;42(Suppl. 57):665s.
  • Demoly P, Le Gall M, Roux M, et al. Safety and tolerability of high doses of sublingual tablet of house dust mite allergen extracts in subjects with house dust mite-associated respiratory allergy. Allergy. 2015;70(Suppl. 101):1–649.
  • Le Gall M, Demoly PM, Rodriguez P, et al. Immunological effects of treatment with STG320 sublingual tablets of house dust mite allergen extracts in subjects with HDM-associated allergic asthma. J Allergy Clin Immunol. 2016;137(2 Suppl):AB404.

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