A prospective study comparing the efficacy and safety of two sublingual birch allergen preparations

Abstract

BackgroundSUBLIVAC 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.MethodsA 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.ResultsAnalysis 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.ConclusionTaken 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.

Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season

“…The most frequent treatment-emergent AEs were local reactions such as oral pruritus, mouth oedema, and throat irritation. Klimek et al 40 . reported treatment-emergent AEs in 75.7% of patients undergoing SLIT with liquid solutions for birch pollen allergy.…”

A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT‐birch pollen extract for the treatment of allergic rhinitis: results of a phase II study

“…In a previous clinical trial, the 10 000 AUN/ml dose was shown to be noninferior to Staloral birch by means of reduction in allergy symptoms assessed by a TNPT and an increase in serum‐specific IgG 4 levels to Bet v 1 . Staloral birch is a registered product with demonstrated clinical efficacy during the birch pollen season .…”

“…The product investigated here is a sublingual liquid birch pollen preparation (SB). In a previous clinical study, SB at a dose of 10 000 AUN/ml was shown to be noninferior to a similar SLIT product by means of reduction in allergy symptoms assessed by a TNPT and an increase in serum‐specific IgG 4 levels to the major birch pollen allergen, Bet v 1 .…”

Smoking effects on quality of life of allergic rhinitis patients after sublingual immunotherapy

“…It consists of the administration of gradually increasing doses of specific allergen extracts to which the patient is sensitized (positive SPT's) and in conjunction to history is considered allergic (7,8) . SLIT consisted of Staloral (36) around 0.5 a "moderate" effect and 0.8 to infinity, a "large" effect (37) . To assess the independent effect of the number of packyears on the post-therapy changes of the QoL questionnaires multivariate linear regression analysis was constructed.…”

“…(10 I.R./ml and 300 I.R./ml; Stallergenes, Antony, France; build-up phase 10 I.R./ml for 1 week and then 300 IR/mL for 1 week gradually increasing every day and maintenance phase 300 I.R./ml eight applications three times a week) or Sublivac(36) (10,000 AUN/ml; HAL Allergy BV, The Netherlands; build-up up-dosing phase lasting 5 days gradually increasing every day and maintenance dosage of 5 droops every day). In polysensitized patients we used a mixture of no more than two antigens, according to SPT's results, history and clinical information.…”