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A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients

O Pfaar, MJ Nell, JD Boot, SA Versteeg, R van Ree, A Roger, H Riechelmann, A Sperl, JNG Oude Elberink, Z Diamant, et al. (2016) ALLERGY. 71(7). p.967-976
abstract
Background: The safety and tolerability of a mite allergoid subcutaneous allergen immunotherapy (SCIT) product was previously established. The aim of this study (EudraCT number: 2011-000393-61) was to find the optimally safe and effective allergoid dose by evaluating several dosages in patients with house dust mite (HDM)-induced allergic rhinoconjunctivitis (ARC) using a titrated nasal provocation test (TNPT). Methods: In total, 290 adult ARC patients (148 females; 142 males) with established HDM allergy and with a positive TNPT were randomized to receive placebo or mite allergoid SCIT 6667, 20 000, 50 000 or 100 000 AUeq/ml for 12 months. Patients were updosed weekly, followed by monthly maintenance dosing. The primary study endpoint comprised the clinical response to TNPT after 12 months of treatment. Secondary endpoints included response to TNPT after 6 months, PNIF measurements, symptom and medication scores during the last 8 weeks of treatment, serum immunoglobulins and safety assessments. Results: After 12 months, a dose-response was observed showing statistically significant improvements in the TNPT with SCIT concentrations of >= 20 000 AUeq/ml, while no significantly different outcomes were reached after 6 months. Specific serum IgG and IgG4 levels were dose dependently increased. In the highest dose group, more treatment-emergent adverse events were observed compared with the lower dose groups. Conclusion: In this mite allergoid SCIT dose finding study in HDM-induced ARC, concentrations of >= 20 000 AUeq/ml showed both immunological effects and clinical efficacy in the TNPT compared with placebo. The risk-benefit ratio favours 20 000 AUeq/ml and 50 000 AUeq/ml strengths for further clinical development.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
allergic rhinoconjunctivitis, allergoid, dose finding, house dust mites, subcutaneous immunotherapy, HOUSE-DUST MITE, SUBLINGUAL IMMUNOTHERAPY, RHINITIS, SAFETY, EFFICACY, EXTRACT, DESLORATADINE, TABLETS, TRIALS
journal title
ALLERGY
Allergy
volume
71
issue
7
pages
967 - 976
Web of Science type
Article
Web of Science id
000378280200006
JCR category
ALLERGY
JCR impact factor
7.361 (2016)
JCR rank
2/26 (2016)
JCR quartile
1 (2016)
ISSN
0105-4538
DOI
10.1111/all.12860
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
8506403
handle
http://hdl.handle.net/1854/LU-8506403
date created
2017-01-31 13:38:30
date last changed
2017-03-21 10:00:14
@article{8506403,
  abstract     = {Background: The safety and tolerability of a mite allergoid subcutaneous allergen immunotherapy (SCIT) product was previously established. The aim of this study (EudraCT number: 2011-000393-61) was to find the optimally safe and effective allergoid dose by evaluating several dosages in patients with house dust mite (HDM)-induced allergic rhinoconjunctivitis (ARC) using a titrated nasal provocation test (TNPT). 
Methods: In total, 290 adult ARC patients (148 females; 142 males) with established HDM allergy and with a positive TNPT were randomized to receive placebo or mite allergoid SCIT 6667, 20 000, 50 000 or 100 000 AUeq/ml for 12 months. Patients were updosed weekly, followed by monthly maintenance dosing. The primary study endpoint comprised the clinical response to TNPT after 12 months of treatment. Secondary endpoints included response to TNPT after 6 months, PNIF measurements, symptom and medication scores during the last 8 weeks of treatment, serum immunoglobulins and safety assessments. 
Results: After 12 months, a dose-response was observed showing statistically significant improvements in the TNPT with SCIT concentrations of {\textrangle}= 20 000 AUeq/ml, while no significantly different outcomes were reached after 6 months. Specific serum IgG and IgG4 levels were dose dependently increased. In the highest dose group, more treatment-emergent adverse events were observed compared with the lower dose groups. 
Conclusion: In this mite allergoid SCIT dose finding study in HDM-induced ARC, concentrations of {\textrangle}= 20 000 AUeq/ml showed both immunological effects and clinical efficacy in the TNPT compared with placebo. The risk-benefit ratio favours 20 000 AUeq/ml and 50 000 AUeq/ml strengths for further clinical development.},
  author       = {Pfaar, O and Nell, MJ and Boot, JD and Versteeg, SA and van Ree, R and Roger, A and Riechelmann, H and Sperl, A and Oude Elberink, JNG and Diamant, Z and Bachert, Claus},
  issn         = {0105-4538},
  journal      = {ALLERGY},
  keyword      = {allergic rhinoconjunctivitis,allergoid,dose finding,house dust mites,subcutaneous immunotherapy,HOUSE-DUST MITE,SUBLINGUAL IMMUNOTHERAPY,RHINITIS,SAFETY,EFFICACY,EXTRACT,DESLORATADINE,TABLETS,TRIALS},
  language     = {eng},
  number       = {7},
  pages        = {967--976},
  title        = {A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients},
  url          = {http://dx.doi.org/10.1111/all.12860},
  volume       = {71},
  year         = {2016},
}

Chicago
Pfaar, O, MJ Nell, JD Boot, SA Versteeg, R van Ree, A Roger, H Riechelmann, et al. 2016. “A Randomized, 5-arm Dose Finding Study with a Mite Allergoid SCIT in Allergic Rhinoconjunctivitis Patients.” Allergy 71 (7): 967–976.
APA
Pfaar, O, Nell, M., Boot, J., Versteeg, S., van Ree, R., Roger, A., Riechelmann, H., et al. (2016). A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients. ALLERGY, 71(7), 967–976.
Vancouver
1.
Pfaar O, Nell M, Boot J, Versteeg S, van Ree R, Roger A, et al. A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients. ALLERGY. 2016;71(7):967–76.
MLA
Pfaar, O, MJ Nell, JD Boot, et al. “A Randomized, 5-arm Dose Finding Study with a Mite Allergoid SCIT in Allergic Rhinoconjunctivitis Patients.” ALLERGY 71.7 (2016): 967–976. Print.