PMID- 33317341 OWN - NLM STAT- MEDLINE DCOM- 20220202 LR - 20220202 IS - 1750-7448 (Electronic) IS - 1750-743X (Linking) VI - 13 IP - 3 DP - 2021 Feb TI - Safety of semi-depot house dust mite allergen extract in children and adolescents with allergic rhinitis and asthma. PG - 227-239 LID - 10.2217/imt-2020-0232 [doi] AB - Aim: Multicenter study to investigate the safety of mite extract product Novo-Helisen Depot, Strengths 1 to 3 (NHD3), as subcutaneous immunotherapy (SCIT), in Chinese children and adolescents with allergic rhinitis (AR) and allergic asthma (AA). Patients & methods: We evaluated SCIT-related adverse events (AEs) during NHD3 14-week initial therapy in children (5-11 years) and adolescents (12-17 years) with perennial symptomatic AR and AA. Results: Among 3600 injections in 250 patients, 361/3600 (10.0%) injections caused SCIT-related AEs in 96/250 (38.4%) patients, 321/3600 injections (8.9%) caused local reactions in 89/250 (35.6%) and 40/3600 injections (1.1%) caused systemic reactions in 23/250 (9.2%). Conclusion: Initial SCIT treatment using NHD3 was safe and well tolerated in Chinese children and adolescents with AR and AA. FAU - Xiang, Li AU - Xiang L AD - Department of Allergy, Beijing Children's Hospital, Beijing 100045, China. FAU - Liu, Fengxia AU - Liu F AD - Department of Allergy, Weifang People's Hospital, Weifang 261200, China. FAU - Zhi, Lili AU - Zhi L AD - Department of Allergy, Central Hospital of Zibo, Zibo 255020, China. FAU - Jiang, Weihong AU - Jiang W AD - Department of Otorhinolaryngology, Xiangya Hospital of Central South University, Changsha 410008, China. FAU - Liu, Changshan AU - Liu C AD - Department of Pediatrics, The Second Hospital of Tianjin Medical University, Tianjin 300211, China. FAU - Xie, Hua AU - Xie H AD - Department of Respiratory, General Hospital of Northern Theater Command, Shenyang 110015, China. FAU - Zhou, Xiaoqin AU - Zhou X AD - Department of Pediatrics, Hubei Provincial Maternal & Child Health Hospital, Wuhan 430070, China. FAU - Sun, Yuemei AU - Sun Y AD - Department of Allergy, Yantai Yuhuangding Hospital, Yantai 264000, China. FAU - Zheng, Yuejie AU - Zheng Y AD - Department of Respiratory, Shenzhen Children's Hospital, Shenzhen 518026, China. FAU - Zhu, Rongfei AU - Zhu R AD - Department of Allergy, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan 430030, China. FAU - Tao, Zezhang AU - Tao Z AD - Department of Otorhinolaryngology, Renmin Hospital of Wuhan University, Wuhan 430060, China. FAU - Xia, Wanmin AU - Xia W AD - Department of Pediatric Respiratory Medicine, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 611731, China. FAU - Lai, He AU - Lai H AD - Department of Allergy, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, China. FAU - Wei, Qingyu AU - Wei Q AD - Department of Allergy, General Hospital of Northern Theater Command, Shenyang 110003, China. FAU - Cheng, Lei AU - Cheng L AD - Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China. AD - International Centre for Allergy Research, Nanjing Medical University, Nanjing 210029, China. FAU - Tang, Yu AU - Tang Y AD - Department of Respiratory, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou 450018, China. FAU - Xu, Rui AU - Xu R AD - Department of Allergy of Otorhinolaryngology Hospital, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China. FAU - Huang, Huijie AU - Huang H AD - Department of Allergy, Beijing Children's Hospital, Beijing 100045, China. FAU - Zhou, Queena AU - Zhou Q AD - Medical Affairs, Merck Serono Co., Ltd, Beijing 100016, China. FAU - Chang, Peter AU - Chang P AD - Global Biostatistics, Epidemiology, Medical Writing (GBEM), Merck Serono Co., Ltd, Beijing 100016, China. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20201215 PL - England TA - Immunotherapy JT - Immunotherapy JID - 101485158 RN - 0 (Antigens, Dermatophagoides) SB - IM MH - Adolescent MH - Animals MH - Antigens, Dermatophagoides/immunology/*therapeutic use MH - Asthma/immunology/*therapy MH - Child MH - Child, Preschool MH - China MH - Desensitization, Immunologic MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - Humans MH - Injections, Subcutaneous MH - Male MH - Medication Adherence MH - Pyroglyphidae/immunology MH - Rhinitis, Allergic/immunology/*therapy MH - Treatment Outcome OTO - NOTNLM OT - adolescents OT - allergic rhinitis OT - asthma OT - children OT - house dust mite OT - multicenter OT - safety OT - semi-depot allergen extract OT - subcutaneous immunotherapy OT - tolerability EDAT- 2020/12/16 06:00 MHDA- 2022/02/03 06:00 CRDT- 2020/12/15 05:38 PHST- 2020/12/16 06:00 [pubmed] PHST- 2022/02/03 06:00 [medline] PHST- 2020/12/15 05:38 [entrez] AID - 10.2217/imt-2020-0232 [doi] PST - ppublish SO - Immunotherapy. 2021 Feb;13(3):227-239. doi: 10.2217/imt-2020-0232. Epub 2020 Dec 15.