PMID- 25097754
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140806
LR  - 20220408
IS  - 2045-7022 (Print)
IS  - 2045-7022 (Electronic)
IS  - 2045-7022 (Linking)
VI  - 4
DP  - 2014
TI  - A prospective study comparing the efficacy and safety of two sublingual birch 
      allergen preparations.
PG  - 23
LID - 10.1186/2045-7022-4-23 [doi]
AB  - BACKGROUND: SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula 
      verrucosa pollen extract for the treatment of allergic 
      rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content 
      of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order 
      to compare the clinical efficacy and safety of both products, the present study 
      was designed to investigate efficacy of treatment with SUB-B compared to Stal-B 
      by means of reduction in allergy symptoms assessed by a titrated nasal 
      provocation test (TNPT) in subjects suffering from IgE mediated allergy 
      complaints triggered by birch pollen. METHODS: A prospective, randomized, open, 
      blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic 
      adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or 
      Stal-B (initial phase 10 I.R./ml and maintenance phase 300 I.R./ml) for 16-20 
      weeks at maintenance dose. The primary efficacy outcome was defined by the 
      difference in change of the TNPT-threshold dose between the two treatment groups 
      at baseline and after completion of treatment. Secondary outcomes included 
      determination of birch pollen specific IgE and IgG levels, safety lab and ECG. 
      During the first 30 days of treatment, subjects were requested to fill out a 
      diary concerning compliance with study medication, occurrence of AEs and the use 
      of concomitant medication. RESULTS: Analysis of the primary efficacy parameter 
      showed that the percentage of subjects showing a beneficial treatment effect was 
      similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the 
      intention to treat population. Evaluation of the immunologic response, showed 
      that treatment with SUB-B and Stal-B induced similar increases (approximately 2 
      times) in IgE, IgG and IgG4 specific for Bet v 1. In total, 143 related adverse 
      events (AEs) were reported. The majority of the AEs was of mild intensity. The 
      same pattern of AEs was observed for both products. No clinically relevant 
      changes in other safety parameters, such as safety laboratory parameters, vital 
      signs, physical examination and ECGs were observed. CONCLUSION: Taken together, 
      treatment with both products was effective by means of reduction in allergic 
      symptoms during a TNPT. In addition, safety analysis revealed a good tolerability 
      of both SLIT extracts.
FAU - Klimek, Ludger
AU  - Klimek L
AD  - Center for Rhinology and Allergology Wiesbaden, Department of 
      Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, 
      Wiesbaden, Germany.
FAU - Sperl, Annette
AU  - Sperl A
AD  - Center for Rhinology and Allergology Wiesbaden, Department of 
      Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, 
      Wiesbaden, Germany.
FAU - van Twuijver, Esther
AU  - van Twuijver E
AD  - HAL Allergy BV, Medical Department, Leiden, The Netherlands.
FAU - van Ree, Ronald
AU  - van Ree R
AD  - Department of Experimental Immunology, Academic Medical Center, University of 
      Amsterdam, Amsterdam, The Netherlands.
FAU - Kleinjans, Huub
AU  - Kleinjans H
AD  - HAL Allergy BV, Medical Department, Leiden, The Netherlands.
FAU - Boot, Johan Diderik
AU  - Boot JD
AD  - HAL Allergy BV, Medical Department, Leiden, The Netherlands.
FAU - Pfaar, Oliver
AU  - Pfaar O
AD  - Center for Rhinology and Allergology Wiesbaden, Department of 
      Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, 
      Wiesbaden, Germany.
LA  - eng
PT  - Journal Article
DEP - 20140723
PL  - England
TA  - Clin Transl Allergy
JT  - Clinical and translational allergy
JID - 101576043
PMC - PMC4122029
OTO - NOTNLM
OT  - Birch pollen allergy
OT  - Nasal provocation test (NPT)
OT  - Non-inferiority design
OT  - Randomized
OT  - Sublingual immunotherapy (SLIT)
EDAT- 2014/08/07 06:00
MHDA- 2014/08/07 06:01
PMCR- 2014/07/23
CRDT- 2014/08/07 06:00
PHST- 2014/02/18 00:00 [received]
PHST- 2014/07/09 00:00 [accepted]
PHST- 2014/08/07 06:00 [entrez]
PHST- 2014/08/07 06:00 [pubmed]
PHST- 2014/08/07 06:01 [medline]
PHST- 2014/07/23 00:00 [pmc-release]
AID - 2045-7022-4-23 [pii]
AID - 10.1186/2045-7022-4-23 [doi]
PST - epublish
SO  - Clin Transl Allergy. 2014 Jul 23;4:23. doi: 10.1186/2045-7022-4-23. eCollection 
      2014.