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Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study.

Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK - Clin Transl Allergy (2014)

Bottom Line: Over the second pollen period, the least square (LS) mean AAdSS was significantly lower in the 300IR group than in the placebo group (LS mean difference -2.04, 95% CI [-2.69, -1.40], (p <0.0001) with a relative reduction of 30.6%.A significant reduction in LS mean AAdSS was also observed over the first pollen season.Efficacy results were consistent in patients with and without oral allergy syndrome.

View Article: PubMed Central - HTML - PubMed

Affiliation: Allergy-Centre-Charité, Charité - Universitätsmedizin Berlin, 10117 Berlin, Germany. margitta.worm@charite.de.

ABSTRACT

Background: Allergic rhinoconjunctivitis (ARC) due to birch pollen is a growing health concern in Europe. Here, we report the efficacy and safety of 300IR birch pollen sublingual solution administered discontinuously for 2 consecutive years to patients with birch-associated allergic rhinoconjunctivitis.

Methods: Birch pollen-allergic adults were randomized in this double blind study to 300IR birch pollen sublingual solution or placebo, daily, starting 4 months before and continuing through the pollen season for two pollen seasons. Randomization was stratified according to the presence or absence of oral allergy syndrome (OAS). The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) over the second pollen season and was analyzed by ANCOVA. Secondary efficacy endpoints included the AAdSS over the first pollen period. Safety was evaluated by means of adverse event monitoring.

Results: 574 patients (284 in the active group and 290 in the placebo group) were randomized and 496 completed the study. Over the second pollen period, the least square (LS) mean AAdSS was significantly lower in the 300IR group than in the placebo group (LS mean difference -2.04, 95% CI [-2.69, -1.40], (p <0.0001) with a relative reduction of 30.6%. Results were consistent in patients with and without OAS (-33.6% and -28.4%, respectively). A significant reduction in LS mean AAdSS was also observed over the first pollen season. The most frequently reported adverse events were application site reactions: oral pruritus, throat irritation, and mouth edema. There were no reports of anaphylaxis.

Conclusions: Pre- and co-seasonal treatment with 300IR birch pollen sublingual solution demonstrated sustained clinical efficacy over 2 pollen seasons and was well tolerated in adults with birch pollen-associated allergic rhinoconjunctivitis. Efficacy results were consistent in patients with and without oral allergy syndrome.

Trial registration: ClinicalTrials.gov: NCT01731249.

No MeSH data available.


Related in: MedlinePlus

Immunological markers (FASP1, FASP2). Serum specific-IgG4 levels (A) and serum specific-IgE levels (B) at baseline, at the end of pollen period (Period 1), 4 months before the pollen period (Period 2) and at the end of the pollen period (Period 2).
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Figure 7: Immunological markers (FASP1, FASP2). Serum specific-IgG4 levels (A) and serum specific-IgE levels (B) at baseline, at the end of pollen period (Period 1), 4 months before the pollen period (Period 2) and at the end of the pollen period (Period 2).

Mentions: At study entry, birch-specific serum IgE and IgG4 were similar in the 300IR and placebo groups. At the end of the second pollen period, the change from baseline in birch-specific serum IgE was similar in the two treatment groups, however, birch-specific serum IgG4 increased by about four-fold in the 300IR group but was essentially unchanged in the placebo group (Figure 7).


Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study.

Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK - Clin Transl Allergy (2014)

Immunological markers (FASP1, FASP2). Serum specific-IgG4 levels (A) and serum specific-IgE levels (B) at baseline, at the end of pollen period (Period 1), 4 months before the pollen period (Period 2) and at the end of the pollen period (Period 2).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3928083&req=5

Figure 7: Immunological markers (FASP1, FASP2). Serum specific-IgG4 levels (A) and serum specific-IgE levels (B) at baseline, at the end of pollen period (Period 1), 4 months before the pollen period (Period 2) and at the end of the pollen period (Period 2).
Mentions: At study entry, birch-specific serum IgE and IgG4 were similar in the 300IR and placebo groups. At the end of the second pollen period, the change from baseline in birch-specific serum IgE was similar in the two treatment groups, however, birch-specific serum IgG4 increased by about four-fold in the 300IR group but was essentially unchanged in the placebo group (Figure 7).

Bottom Line: Over the second pollen period, the least square (LS) mean AAdSS was significantly lower in the 300IR group than in the placebo group (LS mean difference -2.04, 95% CI [-2.69, -1.40], (p <0.0001) with a relative reduction of 30.6%.A significant reduction in LS mean AAdSS was also observed over the first pollen season.Efficacy results were consistent in patients with and without oral allergy syndrome.

View Article: PubMed Central - HTML - PubMed

Affiliation: Allergy-Centre-Charité, Charité - Universitätsmedizin Berlin, 10117 Berlin, Germany. margitta.worm@charite.de.

ABSTRACT

Background: Allergic rhinoconjunctivitis (ARC) due to birch pollen is a growing health concern in Europe. Here, we report the efficacy and safety of 300IR birch pollen sublingual solution administered discontinuously for 2 consecutive years to patients with birch-associated allergic rhinoconjunctivitis.

Methods: Birch pollen-allergic adults were randomized in this double blind study to 300IR birch pollen sublingual solution or placebo, daily, starting 4 months before and continuing through the pollen season for two pollen seasons. Randomization was stratified according to the presence or absence of oral allergy syndrome (OAS). The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) over the second pollen season and was analyzed by ANCOVA. Secondary efficacy endpoints included the AAdSS over the first pollen period. Safety was evaluated by means of adverse event monitoring.

Results: 574 patients (284 in the active group and 290 in the placebo group) were randomized and 496 completed the study. Over the second pollen period, the least square (LS) mean AAdSS was significantly lower in the 300IR group than in the placebo group (LS mean difference -2.04, 95% CI [-2.69, -1.40], (p <0.0001) with a relative reduction of 30.6%. Results were consistent in patients with and without OAS (-33.6% and -28.4%, respectively). A significant reduction in LS mean AAdSS was also observed over the first pollen season. The most frequently reported adverse events were application site reactions: oral pruritus, throat irritation, and mouth edema. There were no reports of anaphylaxis.

Conclusions: Pre- and co-seasonal treatment with 300IR birch pollen sublingual solution demonstrated sustained clinical efficacy over 2 pollen seasons and was well tolerated in adults with birch pollen-associated allergic rhinoconjunctivitis. Efficacy results were consistent in patients with and without oral allergy syndrome.

Trial registration: ClinicalTrials.gov: NCT01731249.

No MeSH data available.


Related in: MedlinePlus