Declining frequency of sensitization to fragrance mixes I and II: IVDK-data of the years 2012-2021.

BACKGROUND: EU Commission Regulation 2017/1410 prohibits using atranol and chloroatranol, the main allergens in Evernia prunastri (oakmoss), and hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) in cosmetic products. Oakmoss absolute is contained in fragrance mix (FM) I and HICC in FM II which are patch tested as screening mixtures in the baseline series. OBJECTIVE: To describe the time trends of reaction frequencies to both FMs as well as to their components in FM-positive patients. METHODS: Retrospective analysis of data from the Information Network of Departments of Dermatology (IVDK), 2012-2021. RESULTS: Positive reactions to FM I (FM II) declined from 9.1% (4.7%) in 2012 to 4.6% (3.0%) in 2021. Full breakdown tests were performed in 24% (FM I) and 31% (FM II), respectively, of the mix-positive patients. From this data, frequencies of sensitization to the 14 single fragrances of FM I and FM II were calculated. For the majority, a decline was noted from 2012/2013 to 2020/2021, for oakmoss absolute 1.9%-0.8% and for HICC 1.8%-0.9%. CONCLUSION: EU Commission Regulation 2017/1410 was an effective measure. However, our data have some limitations, possibly causing underestimation of sensitization frequencies to fragrances.

Fast up-dosing with a birch allergoid is safe and well tolerated in allergic rhinitis patients with or without asthma.

AIM: Subcutaneous immunotherapy is effective in treating allergic rhinoconjunctivitis and asthma, but is still inconvenient when heavy schedules are used. A faster dose escalation is desirable. MATERIALS & METHODS: In this open-label, Phase II trial, 130 adults were randomized 1:1 to receive a birch pollen allergoid subcutaneous immunotherapy. Group I with four weekly injections and Group II with seven weekly injections. Safety, tolerability and immunogenicity were assessed. RESULTS: Mild-to-moderate treatment-related adverse events were reported for 57.7% of the patients (Group I: 36, Group II: 39). Tolerability was assessed by physicians and rated as 'good' or 'very good' for 55 patients in Group I (87.3%) and for 63 patients in Group II (94.0%). Levels of IgG and IgG4 increased before and after treatment significantly (p < 0.0001) in both groups. CONCLUSION: Standard versus fast dose escalation is comparable in terms of safety and tolerability.

Open-label parallel dose tolerability study of three subcutaneous immunotherapy regimens in house dust mite allergic patients.

BACKGROUND: The current maintenance dose (10,000 AUeq/monthly) of a subcutaneous allergoid for house dust mite (HDM) immunotherapy has previously shown significant clinical efficacy in patients with HDM induced allergic rhinitis or rhinoconjunctivitis. In order to comply with the 2009 EMA guidelines on immunotherapy products, a study was conducted to evaluate the safety, tolerability and short-term treatment effects of up-dosing regimens with high doses (up to 40,000 AUeq) of allergoid HDM immunotherapy. METHODS: In total 48 patients with HDM-allergic rhinitis or rhinoconjunctivitis (29 M/19 F; 18-53 years) were included and enrolled into one of three up-dosing regimens (1:4:4): 1) a regular regimen with up-dosing to 40,000 AUeq followed by two maintenance doses (total duration 17 weeks), 2) an intermediate regimen (14 weeks) or 3) a fast regimen (11 weeks). Safety and tolerability were evaluated by monitoring of early and late local reactions and systemic reactions. In addition, short-term effects were assessed by conjunctival provocation test (CPT) and levels of serum allergen-specific IgE, IgG and IgG4. RESULTS: Thirty-nine patients completed the study according to protocol. No early local reactions occurred. Late local reactions (LLR) were observed in 12% of the injections. In total, 31 systemic reactions, all grade 1, were reported of which two needed oral antihistamine treatment. No grade 2 or higher systemic reactions were observed. Six patients (15%) did not reach the highest dose due to LLR and/or systemic reactions needing antihistamines (20% in the regular regimen, 16% in the intermediate regimen and 13% in the fast regimen). At the end of the study, an improvement in the CPT was observed in 82.1% of patients, indirectly indicating an early treatment effect at the current dose and higher doses. In addition, IgG4 immunoglobulin levels were significantly increased in all groups following treatment. CONCLUSIONS: In this open-label study, allergoid HDM immunotherapy in doses up to 40,000 AUeq was generally well tolerated and no clinically relevant safety issues were identified. In the safety aspects of the three up-dosing regimens no clinically relevant differences were encountered. Therefore, these dose ranges and up-dosing regimens can be safely included in future dose-finding efficacy studies.