Long-term safety of subcutaneous immunotherapy with TO-204 in Japanese patients with house dust mite-induced allergic rhinitis and allergic bronchial asthma: Multicenter, open label clinical trial

Bousquet, 1998, Allergen immunotherapy: therapeutic vaccines for allergic diseases. A WHO position paper, J Allergy Clin Immunol, 102, 558, 10.1016/S0091-6749(98)70271-4 Burks, 2013, Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report, J Allergy Clin Immunol, 131, 1288, 10.1016/j.jaci.2013.01.049 Jutel, 2016, International consensus on allergen immunotherapy II: mechanisms, standardization, and pharmacoeconomics, J Allergy Clin Immunol, 137, 358, 10.1016/j.jaci.2015.12.1300 Cox, 2011, Allergen immunotherapy: a practice parameter third update, J Allergy Clin Immunol, 127, S1, 10.1016/j.jaci.2010.09.034 Jutel, 2015, International consensus on allergy immunotherapy, J Allergy Clin Immunol, 136, 556, 10.1016/j.jaci.2015.04.047 Des Roches, 1997, Immunotherapy with a standardized Dermatophagoides pteronyssinus extract. VI. Specific immunotherapy prevents the onset of new sensitizations in children, J Allergy Clin Immunol, 99, 450, 10.1016/S0091-6749(97)70069-1 Jacobsen, 2007, Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study, Allergy, 62, 943, 10.1111/j.1398-9995.2007.01451.x Marogna, 2010, Long-lasting effects of sublingual immunotherapy according to its duration: a 15-year prospective study, J Allergy Clin Immunol, 126, 969, 10.1016/j.jaci.2010.08.030 Niggemann, 2006, Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children, Allergy, 61, 855, 10.1111/j.1398-9995.2006.01068.x Nagata, 2001, [An evaluation of the long-term effect of clustered immunotherapy in house-dust-mite-sensitive adult bronchial asthma], Arerugi, 50, 435 Tanaka, 2015, [Safety and efficacy of one-year rush subcutaneous immunotherapy in Japanese children, using house dust extract], Arerugi, 64, 1160 Abramson, 2010, Injection allergen immunotherapy for asthma, Cochrane Database Syst Rev, 8 Blumberga, 2011, SQ-standardized house dust mite immunotherapy as an immunomodulatory treatment in patients with asthma, Allergy, 66, 178, 10.1111/j.1398-9995.2010.02451.x Pajno, 2001, Prevention of new sensitizations in asthmatic children monosensitized to house dust mite by specific immunotherapy. A six-year follow-up study, Clin Exp Allergy, 31, 1392, 10.1046/j.1365-2222.2001.01161.x Varney, 2003, Usefulness of specific immunotherapy in patients with severe perennial allergic rhinitis induced by house dust mite: a double-blind, randomized, placebo-controlled trial, Clin Exp Allergy, 33, 1076, 10.1046/j.1365-2222.2003.01735.x Dhami, 2017, Allergen immunotherapy for allergic asthma: a systematic review and meta-analysis, Allergy, 72, 1825, 10.1111/all.13208 Dhami, 2017, Allergen immunotherapy for allergic rhinoconjunctivitis: a systematic review and meta-analysis, Allergy, 72, 1597, 10.1111/all.13201 Erekosima, 2014, Effectiveness of subcutaneous immunotherapy for allergic rhinoconjunctivitis and asthma: a systematic review, Laryngoscope, 124, 616, 10.1002/lary.24295 Zuberbier, 2010, GA(2) LEN/EAACI pocket guide for allergen-specific immunotherapy for allergic rhinitis and asthma, Allergy, 65, 1525, 10.1111/j.1398-9995.2010.02474.x Okubo, 2011, Japanese guideline for allergic rhinitis, Allergol Int, 60, 171, 10.2332/allergolint.11-RAI-0334 Hamasaki, 2014, Japanese guideline for childhood asthma 2014, Allergol Int, 63, 335, 10.2332/allergolint.14-RAI-0767 Ohta, 2014, Japanese guideline for adult asthma 2014, Allergol Int, 63, 293, 10.2332/allergolint.14-RAI-0766 Stelmach, 2012, Comparison of the long-term efficacy of 3- and 5-year house dust mite allergen immunotherapy, Ann Allergy Asthma Immunol, 109, 274, 10.1016/j.anai.2012.07.015 Marogna, 2008, Preventive effects of sublingual immunotherapy in childhood: an open randomized controlled study, Ann Allergy Asthma Immunol, 101, 206, 10.1016/S1081-1206(10)60211-6 Takai, 2015, Japanese Society of Allergology task force report on standardization of house dust mite allergen vaccines – secondary publication, Allergol Int, 64, 181, 10.1016/j.alit.2015.01.005 European Medicines Agency. Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases 2008. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003605.pdf. [Accessed 20 September 2017]. Nathan, 2004, Development of the asthma control test: a survey for assessing asthma control, J Allergy Clin Immunol, 113, 59, 10.1016/j.jaci.2003.09.008 Liu, 2007, Development and cross-sectional validation of the childhood asthma control test, J Allergy Clin Immunol, 119, 817, 10.1016/j.jaci.2006.12.662 Arioka, 2006, [Bronchial asthma and QOL], Nihon Naika Gakkai Zasshi [J Jpn Soc Int Med], 95, 1507, 10.2169/naika.95.1507 Kondo, 2008, [QOL questionnaire for pediatric patients with bronchial asthma and their parents or caregivers. Preparation and evaluation of the short form version 2008 (Gifu)], Arerugi, 57, 1022 Simons, 2011, World allergy organization guidelines for the assessment and management of anaphylaxis, World Allergy Organ J, 4, 13, 10.1097/WOX.0b013e318211496c 2015 Cox, 2010, Speaking the same language: the World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System, J Allergy Clin Immunol, 125, 569, 10.1016/j.jaci.2009.10.060 DaVeiga, 2011, Systemic reactions associated with subcutaneous allergen immunotherapy: timing and risk assessment, Ann Allergy Asthma Immunol, 106, 533, 10.1016/j.anai.2011.02.007 Epstein, 2014, AAAAI/ACAAI surveillance study of subcutaneous immunotherapy, years 2008–2012: an update on fatal and nonfatal systemic allergic reactions, J Allergy Clin Immunol Pract, 2, 161, 10.1016/j.jaip.2014.01.004 Epstein, 2011, Immediate and delayed-onset systemic reactions after subcutaneous immunotherapy injections: ACAAI/AAAAI surveillance study of subcutaneous immunotherapy: year 2, Ann Allergy Asthma Immunol, 107, 426, 10.1016/j.anai.2011.05.020 Pfaar, 2016, A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients, Allergy, 71, 967, 10.1111/all.12860 Rieker-Schwienbacher, 2013, Open-label parallel dose tolerability study of three subcutaneous immunotherapy regimens in house dust mite allergic patients, Clin Transl Allergy, 3, 16, 10.1186/2045-7022-3-16 Lieberman, 2012, The risk and management of anaphylaxis in the setting of immunotherapy, Am J Rhinol Allergy, 26, 469, 10.2500/ajra.2012.26.3811 Caminati, 2015, Incidence and risk factors for subcutaneous immunotherapy anaphylaxis: the optimization of safety, Expert Rev Clin Immunol, 11, 233, 10.1586/1744666X.2015.988143 Brozek, 2010, Allergic rhinitis and its Impact on asthma (ARIA) guidelines: 2010 revision, J Allergy Clin Immunol, 126, 466, 10.1016/j.jaci.2010.06.047 Okamoto, 2014, Guiding principles of subcutaneous immunotherapy for allergic rhinitis in Japan, Auris Nasus Larynx, 41, 1, 10.1016/j.anl.2013.06.003 U.S. Department of Health and Human Services, 2007, National asthma education and prevention program. Expert Panel Report 3 (EPR-3): guidelines for the diagnosis and management of asthma-Summary report 2007, J Allergy Clin Immunol, 120, S94, 10.1016/j.jaci.2007.09.029 Calderon, 2007, Allergen injection immunotherapy for seasonal allergic rhinitis, Cochrane Database Syst Rev, 1 Calderon, 2011, Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond, J Allergy Clin Immunol, 127, 30, 10.1016/j.jaci.2010.08.024 Frew, 2006, Efficacy and safety of specific immunotherapy with SQ allergen extract in treatment-resistant seasonal allergic rhinoconjunctivitis, J Allergy Clin Immunol, 117, 319, 10.1016/j.jaci.2005.11.014 Calderon, 2013, An evidence-based analysis of house dust mite allergen immunotherapy: a call for more rigorous clinical studies, J Allergy Clin Immunol, 132, 1322, 10.1016/j.jaci.2013.09.004 Okamoto, 2015, Efficacy and safety of sublingual immunotherapy for two seasons in patients with Japanese cedar pollinosis, Int Arch Allergy Immunol, 166, 177, 10.1159/000381059 Okubo, 2017, Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite-induced allergic rhinitis, J Allergy Clin Immunol, 139, 1840, 10.1016/j.jaci.2016.09.043