PMID- 30294519
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2197-0378 (Print)
IS  - 2197-0378 (Electronic)
IS  - 2197-0378 (Linking)
VI  - 27
IP  - 5
DP  - 2018
TI  - SCIT with a high-dose house dust mite allergoid is well tolerated: safety data 
      from pooled clinical trials and more than 10 years of daily practice analyzed in 
      different subgroups.
PG  - 131-139
LID - 10.1007/s40629-018-0059-x [doi]
AB  - BACKGROUND: Efficacy of house dust mite (HDM) allergen immunotherapy (AIT) in 
      allergic rhinitis and controlled allergic asthma has been documented in 
      controlled trials with adults and children. However, tolerability comparing 
      clinical development and post marketing data, particularly in different 
      subgroups, is missing. METHODS: We performed an analysis of pooled safety data 
      for subcutaneous AIT (SCIT) with a high-dose house dust mite allergoid from 6 
      randomized, controlled trials (RCT) in HDM allergic respiratory disease (ARD) and 
      of post marketing safety data from more than 10 years including different 
      subgroups (age, gender, asthma status). RESULTS: In all, 500 patients with ARD 
      were treated in RCTs: 279 received the marketed dose of 1800 protein nitrogen 
      units (PNU) high-dose HDM allergoid AIT (214 double-blind placebo controlled 
      [HDM-DBPC], 65 children/adolescents usual care controlled [HDM-RCT(UC)]), and 221 
      placebo (PL). 38.8% adverse events (AEs) were observed with 1800 PNU in HDM-DBPC 
      (31.2% PL, 35.5% HDM-ALL [1800 PNU]); the difference was primarily because of 
      local reactions; there was no difference in systemic reactions (10.9% PL, 11.2% 
      HDM-DBPC, 11.2% HDM-ALL); one out of 279 high-dose HDM allergoid-treated patients 
      had a serious adverse event (SAE).Children (n = 39)/adolescents (n = 26) had 
      fewer related AEs and local reactions compared to adults; systemic reactions: 
      children 12.8%, adults 11.2% adolescents 7.7%. Females had slightly more AEs. 
      Treatment was well tolerated in asthmatic patients (n = 267; GINA I n = 32, 
      II n = 104, III n = 17, 114 no classification).In more than 10 years more than 
      100,000 patients were treated with high-dose HDM allergoid (1800 PNU) under daily 
      practice conditions. Adverse drug reactions (ADRs) were reported in 0.5% of 
      patients. 94.6% of these ADRs were expected. CONCLUSION: SCIT with the marketed 
      dose of high-dose HDM allergoid was well tolerated in clinical development and in 
      daily practice. There was no increased risk for the investigated patient 
      subgroups. Tolerability was comparable to HDM sublingual immunotherapy (SLIT) 
      tablets.
FAU - Klimek, Ludger
AU  - Klimek L
AD  - Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, 
      Germany.
FAU - Fox, Gabriele-Cornelia
AU  - Fox GC
AD  - 2Allergopharma GmbH & Co. KG, Reinbek bei Hamburg, Germany. ISNI: 0000 0001 0672 
      7022. GRID: grid.39009.33
FAU - Thum-Oltmer, Susanne
AU  - Thum-Oltmer S
AD  - 2Allergopharma GmbH & Co. KG, Reinbek bei Hamburg, Germany. ISNI: 0000 0001 0672 
      7022. GRID: grid.39009.33
LA  - eng
PT  - Journal Article
DEP - 20180725
PL  - Germany
TA  - Allergo J Int
JT  - Allergo journal international
JID - 101659261
PMC - PMC6153715
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - Asthma
OT  - Children
OT  - Subcutaneous allergen immunotherapy
OT  - Tolerability
COIS- L. Klimek has received research grants from ALK-Abello, Denmark; Allergopharma, 
      Germany; Bionorica, Germany; Biomay, Austria, Boehringer Ingelheim, Germany, 
      Circassia, USA; Stallergenes, France; HAL, Netherlands; Allergy 
      Therapeutics/Bencard, Great Britain/Germany; Hartington, Spain; Lofarma, Italy; 
      MEDA, Sweden; Novartis, Switzerland, Leti, Spain; ROXALL, Germany; 
      Glaxo-Smith-Kline (GSK), Great Britain; Cytos, Switzerland; Curalogic, Denmark; 
      and/or has served on the speaker's bureau or was consulting for the above 
      mentioned pharmaceutical companies. G.-C. Fox and S. Thum-Oltmer are employees of 
      Allergopharma GmbH & Co. KG, Reinbek, Germany.
EDAT- 2018/10/09 06:00
MHDA- 2018/10/09 06:01
PMCR- 2018/07/25
CRDT- 2018/10/09 06:00
PHST- 2018/01/09 00:00 [received]
PHST- 2018/03/08 00:00 [accepted]
PHST- 2018/10/09 06:00 [entrez]
PHST- 2018/10/09 06:00 [pubmed]
PHST- 2018/10/09 06:01 [medline]
PHST- 2018/07/25 00:00 [pmc-release]
AID - 59 [pii]
AID - 10.1007/s40629-018-0059-x [doi]
PST - ppublish
SO  - Allergo J Int. 2018;27(5):131-139. doi: 10.1007/s40629-018-0059-x. Epub 2018 Jul 
      25.