Reliability of a New Symptom Score in a Titrated Quantitative Conjunctival Provocation Test Supported by an Objective Photodocumentation

Pfaar, Oliver; Claßen, Dan Philipp; Astvatsatourov, A.; Klimek, Ludger; Mösges, Ralph

doi:10.1159/000487884

Cited by 8 publications

(30 citation statements)

References 29 publications

(35 reference statements)

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“…Despite differences in how CPT is performed, all methods use a standard range of titrated allergen concentrations applied to the conjunctiva and PROMs. The CIA‐CPT© uniquely allows both subject and investigator to contribute to scoring symptoms (a mixed PROM), and the test‐retest reliability has been investigated in a pilot methodological trial . Studying subjects individually avoids collusion and follows best practice for PROMs.…”

Section: Discussionmentioning

confidence: 99%

“…Conjunctival Provocation Test (CPT) (see Appendix ) was performed at the first visit and repeated at subsequent visits to confirm eligibility and establish the baseline score prior to randomization. Study treatment was administered, and post‐treatment CPT was performed 3‐4 weeks (+/−3 days) after the last injection.…”

Section: Methodsmentioning

confidence: 99%

“…Birch pollen allergen CPT material was supplied by Laboratorios LETI S.L (see Appendix ) and administered at concentrations of 0.3, 1.0, 3.0 and 10 histamine equivalent potency (HEP)/mL. Additionally, the original reconstituted allergen solution of 30 HEP/mL was used post‐treatment, if a subject tested negative to all other concentrations (see Appendix ). Aqueous diluent served as the negative control.…”

Section: Methodsmentioning

confidence: 99%

“…Four eye symptoms after challenge with the allergen or negative control were recorded as subject and investigator reported outcomes (mixed patient‐reported outcomes measures [PROMs]) using a severity rating scale as follows: 0 = absent, 1 = mild, 2 = moderate and 3 = severe. Subjects independently scored the eye symptoms of itching and irritation, followed by co‐assessment of eye tearing in conjunction with the investigator and scoring of eye redness by the investigator independent of the subject . This questionnaire (Culture‐Independent Assessment of the Conjunctival Provocation Test [CIA‐CPT©]) was conducted 10 minutes after application of negative control or allergen.…”

Section: Methodsmentioning

confidence: 99%

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Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

Worm

Higenbottam

Pfaar

et al. 2018

Allergy

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BackgroundThe Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX ® Quattro Plus 1.0 ml Birch 100%) is an effective, well‐tolerated short course subcutaneous immunotherapy. We performed 2 phase II studies to determine its optimal cumulative dose.MethodsThe studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012‐004336‐28 PQBirch203 and 2015‐000984‐15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season. Conjunctival Provocation Tests were performed at screening, baseline and 3‐4 weeks after completing treatment, to quantify the reduction in Total Symptom Scores (as the primary endpoint) with each cumulative dose. Multiple Comparison Procedure and Modeling analysis was used to test for the dose response, shape of the curve and estimation of the median effective dose (ED 50), a measure of potency.ResultsStatistically significant dose responses (P < .01 & .001) were seen, respectively. The highest cumulative dose in PQBirch204 (27 300 standardized units [SU]) approached a plateau. Potency of the PQBirch was demonstrated by an ED 50 2723 SU, just over half the current dose. Prevalence of treatment‐emergent adverse events was similar for active doses, most being short‐lived and mild. Compliance was over 85% in all groups.ConclusionIncreasing the cumulative dose of PQBirch 5.5‐fold from 5100 to 27 300 SU achieved an absolute point difference from placebo of 1.91, a relative difference 32.3% and an increase in efficacy of 50%, without compromising safety. The cumulative dose response was confirmed to be curvilinear in shape.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

Worm

Higenbottam

Pfaar

et al. 2018

Allergy

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“…Moreover, using new media and building up networks will help to raise awareness and spread information, both to health professionals and to patients [16]. In order to standardize measures of outcome with conjunctival provocation tests, the use of a new scoring protocol, including the items itching, irritation, tearing, and redness supported by an objective photodocumentation, has been validated [17]. …”

Section: Characterization Of Subgroups Of Allergic Rhinitismentioning

confidence: 99%

Recent Advances in Clinical Allergy and Immunology

Simon

2018

Int Arch Allergy Immunol

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Allergic diseases are of great concern because of their high prevalence, which is still rising in several regions, their impact on patients’ physical and psychological health, the huge burden they place on patients’ quality of life, as well as the socioeconomic consequences that they cause. Recent research has provided new data on both genetic and environmental risk factors of atopic/allergic diseases. The application of new technologies such as “omics” has allowed a better understanding of the pathogenesis and has helped with the identification of therapeutic targets. Immense progress has been made in developing and applying novel, targeted therapies, for example for asthma and urticaria. Intensive efforts are being made to find biomarkers that help to classify patients, to identify their potential responsiveness to specific therapies, and to monitor the disease severity. Based on recent insights in the pathogenesis of food allergy and drug hypersensitivity, novel strategies for diagnostics, allergen avoidance, and induction of tolerance have been developed. Here, we summarize important findings in the field of clinical allergy and immunology with a special focus on asthma, allergic rhinitis, atopic dermatitis, food allergy, urticaria, angioedema, and drug hypersensitivity.

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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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Reliability of a New Symptom Score in a Titrated Quantitative Conjunctival Provocation Test Supported by an Objective Photodocumentation

Cited by 8 publications

References 29 publications

Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

Recent Advances in Clinical Allergy and Immunology

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

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