Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season

Gherasim, Alina; Dietsch, Frank; Beck, Marine; Domis, Nathalie; Blay, F. De

doi:10.1016/j.waojou.2023.100801

Cited by 3 publications

(6 citation statements)

References 40 publications

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“…49,50 Environment exposure chambers (also referred to as allergen challenge chambers) provide the most 'natural' exposure to aeroallergens and are increasingly being used in Phase II to IV trials of allergy therapies but, for logistic reasons, are not as well suited to studies in which the investigating centres are far from the chamber facility. 47,51,52 A comparison of the CPT with another challenge method would have been interesting but was not logistically possible in the present study. Thirdly, the fact that the study took place outside the birch pollen season could also be considered as a limitation; the effect of SCIT might differ when participants are 'primed' or concomitantly exposed to the natural triggering allergen.…”

Section: Discussionmentioning

confidence: 99%

“…46 In allergology more generally, CPTs are less commonly encountered than nasal provocation tests (NPTs). 47,48 NPTs can be standardized to a good extent, but the results (as a subjective nasal symptom score and/or an objective nasal air flow rate) are sometimes difficult to interpret. 49,50 Environment exposure chambers (also referred to as allergen challenge chambers) provide the most 'natural' exposure to aeroallergens and are increasingly being used in Phase II to IV trials of allergy therapies but, for logistic reasons, are not as well suited to studies in which the investigating centres are far from the chamber facility.…”

Section: Discussionmentioning

confidence: 99%

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A high‐dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

Pfaar,

Sager,

Mösges

et al. 2023

Clinical & Translational All

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BackgroundSubcutaneous allergen immunotherapy (SCIT) with depigmented, polymerized (DPP) birch pollen extract has been marketed at doses of up to 1000 DPP units/mL since 2001. We sought to determine the dose‐dependent efficacy of a DPP birch pollen extract formulation in patients suffering from birch‐pollen‐induced allergic rhinitis or rhinoconjunctivitis with or without intermittent asthma.MethodsA titrated conjunctival provocation test (CPT) was applied as a surrogate marker. This Phase II randomized, double‐blind, parallel‐group, dose‐ranging clinical trial was performed at 39 centres in Germany, Lithuania and Poland. After randomization to four dose‐level groups (100, 1000, 5000 and 10,000 DPP units/mL) and up‐dosing, participants received maintenance SCIT with five monthly subcutaneous injections. The primary endpoint was the proportion of patients in whom a higher concentration of birch pollen (vs. baseline) was needed to elicit a positive CPT.ResultsThree hundred forty‐three patients were included (mean (range) age: 42.6 (19–70)). The highest CPT responder rates were seen in the higher dose‐level groups. In the intention‐to‐treat analysis, the difference between the 100 and 10,000 groups was statistically significant (p = 0.0118). Although the proportion of patients with ≥1 treatment‐emergent adverse events increased with the dose, almost all these events were mild (65.6%) or moderate (18.5%).ConclusionJudging by the results of a CPT, the efficacy/safety ratio in SCIT appears to be favourable for a high‐dose‐level preparation of a DPP birch pollen extract.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A high‐dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

Pfaar,

Sager,

Mösges

et al. 2023

Clinical & Translational All

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show abstract

Section: Discussionmentioning

confidence: 99%

“…The 2018 European Academy of Allergy and Clinical Immunology (EAACI) position paper 2 emphasizes the unmet needs in NAC methodologies, such as standardization of allergen dose and quality, application techniques, and the necessity of a titration process. Recent studies have explored the NAC method for HDM using Allerkin® HDM extract, 20 and for SB pollen, comparing the outcomes of NAC with Allergopharma® allergoid diluted SB and those of environmental exposure chambers 21 . This study contributes to this field by proposing a standardized protocol for HDM and SB pollen.…”

Section: Discussionmentioning

confidence: 99%

“…Recent studies have explored the NAC method for HDM using Allerkin® HDM extract, 20 and for SB pollen, comparing the outcomes of NAC with Allergopharma® allergoid diluted SB and those of environmental exposure chambers. 21 This study contributes to this field by proposing a standardized protocol for HDM and SB pollen. The lack of availability of commercial aqueous allergen extracts is increasingly a problem, and prior research has already demonstrated that sublingual tablets could serve as a viable alternative for NAC with grass pollen.…”

Section: Discussionmentioning

confidence: 99%

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Utility of silver birch and house dust mite extracts derived from licensed sublingual tablets for nasal allergen challenge

Olivieri,

Gil,

Stoenchev

et al. 2024

Clinical & Translational All

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BackgroundNasal allergen challenge (NAC) is used to investigate the effects of allergen exposure and assess treatment efficacy in allergic rhinitis (AR). This study aims to establish dose‐responses to NAC using licensed silver birch (SB) pollen and house dust mite (HDM) sublingual tablets as sources of the allergen extracts in participants with AR.MethodsSixteen volunteers with HDM‐induced perennial AR and 15 volunteers with SB pollen‐induced seasonal rhinitis underwent a graded up‐dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0–12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 (“provoking dose 7”) in most allergic participants was identified. NACs using the “provoking dose 7” were performed on 5 non‐allergic individuals to test for irritant effects. The “provoking dose 7” of HDM extract was used in a subgroup of two SB allergic, non‐HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses.ResultsMost patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non‐allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics.ConclusionFor both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate‐severity response (“provoking dose 7/12”) was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.

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Alleviation of allergic rhinoconjunctivitis symptoms in participants treated with a 0.005% tacrolimus eye drop solution

Sladek,

Unger-Manhart,

Siegl

et al. 2024

Preprint

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Purpose: This randomized, placebo-controlled, crossover, doublel-blind, single site trial was aimed to evaluate efficacy and safety of Tacrosolv, a novel eye drop solution containing solubilized tacrolimus, in adult participants with grass pollen induced allergic conjunctivitis. Methods: 64 adult participants with proven grass pollen allergy were randomized to either 2.5 ug or 5 ug tacrolimus/eye/day or placebo treatment for 8 days. Allergic symptoms were induced by 4h grass pollen exposure on day 1 and day 8. After a 2-week wash-out period, placebo participants crossed over to high or low dose and vice versa, and repeated treatment and exposure. During exposure, participants recorded ocular, nasal and respiratory allergy symptoms every 15 minutes. The primary endpoint was the mean Total Ocular Symptom Score (TOSS) on Day 8. Objective ocular safety parameters were assessed before, during and after exposure. Adverse events (AEs) were recorded throughout the study. Results: On Day 8, TOSS was reduced towards the end of exposure in participants receiving Tacrosolv high dose compared to placebo (p<0.05 at timepoints 3h45min and 4h). Accordingly, intensity of the single ocular symptoms like redness and watery eyes was reduced versus placebo by end of exposure on Day 8. A 26% reduction of baseline adjusted TOSS from day 1 to day 8 was observed in participants treated with high dose Tacrosolv, whereas placebo treated participants showed no difference in TOSS between day 1 and day 8. Interestingly, a significant reduction of total nasal symptoms, mainly itching and sneezing, was seen both on day 1 and day 8 in participants treated with high dose Tacrosolv (p<0.05). No safety concerns were raised upon ocular assessments by the investigator like redness of the eye, corneal and conjunctival staining. All AEs were resolved within the study period. Conclusion: Treatment with Tacrosolv at the dose and frequency studied is safe and alleviates symptoms in participants suffering from allergic rhinoconjunctivitis. Trial registration:NCT04532710; EudraCT No. 2019‐002847‐62 Keywords: Allergic rhinoconjunctivitis, tacrolimus, ocular redness, ocular itching, topical administration, clinical trial.

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Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season

Cited by 3 publications

References 40 publications

A high‐dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

A high‐dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

Utility of silver birch and house dust mite extracts derived from licensed sublingual tablets for nasal allergen challenge

Alleviation of allergic rhinoconjunctivitis symptoms in participants treated with a 0.005% tacrolimus eye drop solution

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