Publications by authors named "Michael Rudert"

3 Publications

  • Page 1 of 1

Sensitivity and specificity of standardised allergen extracts in skin prick test for diagnoses of IgE-mediated respiratory allergies.

Clin Transl Allergy 2019 18;9. Epub 2019 Feb 18.

2Allergopharma GmbH & Co. KG, Hermann-Körner-Str. 52, 21465 Reinbek, Germany.

Background: Skin prick tests (SPTs) are essential for the diagnosis of IgE-mediated allergy and are influenced by extract quality, biological potency and concentration of allergen.

Methods: In this open multicentre study 431 patients, aged 18-64 years were enrolled. Patients had a history of IgE-mediated allergy and a sensitisation (previous positive SPT of any manufacturer) against at least one of the investigated allergens: 6-grass pollen, house dust mite, birch and mugwort pollen. In our study, these allergens were tested in five concentrations each. To establish the optimal trade-off between sensitivity and specificity, the area under the receiver operating characteristic (ROC) curve was estimated by comparing the outcome of the SPT with three methods referred to as 'reference methods' (specific IgE, clinical case history and a previous SPT).

Results: For all allergens and reference methods, the area under the ROC curves were highly significant (p < 0.001). Specific IgE reference method resulted in the largest area under the curve (AUC) for all allergens (0.80-0.90) followed by previous SPT (0.70-0.87) and case history (0.65-0.74). Sensitivity of SPT increased with increasing concentration and specificity decreased. For all allergens, compared to specific IgE, the highest sensitivity (specificity at least 80%) was observed for the SPT solution of 50,000 Standardised Units (SU)/mL (grass pollen, birch pollen, house dust mite and mugwort).

Conclusion: In this study, with a large number of patients, it was demonstrated that clinical case history, previous SPT and specific IgE measurement could all be used as reference methods for the assessment of sensitivity/specificity of SPT solutions. The comparison of SPT with specific IgE resulted in the largest AUC. The highest sensitivity was observed for the SPT solution of 50,000 SU/mL. EudraCT: 2006-005304-14.
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February 2019

Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2-year double-blind, placebo-controlled, randomized trial plus 1-year open-label extension.

Clin Exp Allergy 2019 04 27;49(4):516-525. Epub 2019 Feb 27.

Department of Lung Diseases and Clinical Allergology, University of Turku, Turku, Finland.

Background: Previous clinical trials with birch pollen subcutaneous immunotherapy have been conducted over a 1- to 2-year treatment period and involved mostly a single geographic location.

Objective: This study (EudraCT-Number: 2005-000025-35) intended to evaluate the effect of subcutaneous immunotherapy with high-dose hypoallergenic birch pollen allergoid in patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3-year course in 19 European centres.

Methods: Adults with confirmed birch pollen allergy (n = 253) were randomized to preseasonal placebo (n = 129) or active treatment (n = 124). Primary endpoint was change in Symptom Medication Score after 2 years treatment (2007).

Results: The change in Symptom Medication Score of active- vs placebo-treated patients for the Full Analysis Set (n = 227, 15.2% reduction, P = 0.0710) and Per-Protocol Set (n = 216, 16.7% reduction, P = 0.0523) showed a positive trend, although significance was not achieved. The primary endpoint, assessed in 2007, coincided with the lowest pollination during the study period. In a subgroup analysis of patients in the north-eastern region (n = 102), where birch is the major tree and consequently patients' exposure is higher, changes in Symptom Medication Score (32.7% reduction, P = 0.0034) and median number of well days (P = 0.0232) were highly significant in favour of the active group. During the open-label third year of treatment, the mean Symptom Medication Score of active-treated patients was further reduced despite an increased pollen count. Subcutaneous immunotherapy was well tolerated and consistent with the known safety profile.

Conclusions And Clinical Relevance: Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north-eastern region of Europe, where birch is the predominant tree species. Proving efficacy of birch allergen subcutaneous immunotherapy is challenging due to the numerous factors influencing birch pollen allergen exposure in field studies.
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April 2019

Efficacy and tolerability of a house dust mite allergoid in allergic bronchial asthma: a randomized dose-ranging trial.

Immunotherapy 2018 09 9;10(13):1149-1161. Epub 2018 Aug 9.

Barlicki University Hospital, Medical University, Lodz, Poland.

Aim: This multicenter randomized placebo-controlled double-blind clinical trial investigated which maintenance dose shows the optimal benefit-risk ratio for subcutaneous immunotherapy with a Dermatophagoides pteronyssinus allergoid preparation.

Objective: To evaluate four maintenance doses of the allergoid preparation versus placebo.

Methods: The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control.

Results: A total of 146 adults with bronchial asthma were randomized. After subcutaneous immunotherapy, reductions in swelling size were greatest with 10,000 therapeutic units (TU). The 18,000 TU group showed the highest percentage of patients with fluticasone dose reduced to 0 μg/day.

Conclusion: The optimal dose of allergoid for the investigation in a confirmatory trial with inhaled corticosteroid reduction is 18,000 TU.
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September 2018