Shared Decision-Making in Allergen Immunotherapy (AIT) Options Using a Questionnaire for Respiratory Allergic Patients: A Delphi Consensus Study.

Purpose: The objective of this study was to develop and validate a questionnaire, through a Delphi consensus, to be used by allergists in their routine clinical practice to assess the preferences of patients starting allergen immunotherapy (AIT) treatment using an objective approach. Patients and Methods: A Delphi consensus-driven process was used. The scientific committee, composed of 15 allergists, led the study and participated in the preparation of the questionnaire. Two-hundred panelists from different Spanish regions were invited to complete a 16-item questionnaire on a nine-point Likert scale covering six topic blocks. Consensus was achieved if ≥66.6% of panelists reached agreement or disagreement. Results: Of the 200 experts invited to participate in the Delphi process, a total of 195 (97.5%) answered the questionnaire. The panel experts reached a consensus on "agreement" on a total of 12 of the 16 (75.0%) items, covering a total of six categories: (a) patient knowledge (2 questions), (b) barriers to patient adherence (3 questions), (c) patient behavior (4 questions), (d) future actions (3 questions), (e) treatment costs (2 questions), and (f) final patient preferences (2 questions). Conclusion: This Delphi consensus study validated a set of twelve recommended questions for patients objectively assessing their preferences and suitability for the most common AIT options available. The questionnaire intends to assist allergists in making an objective, unconditioned decision regarding the best AIT option for each patient, after informing them about the different routes.

First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy.

BACKGROUND: Polymerized allergens conjugated to non-oxidized mannan (PM-allergoids) are novel vaccines targeting dendritic cells (DCs). Previous experimental data indicate that PM-allergoids are readily taken up by DCs and induce Treg cells. This first-in-human study was aimed to evaluate safety and to find the optimal dose of house dust mite PM-allergoid (PM-HDM) administered subcutaneously (SC) or sublingually (SL). METHODS: In a randomized, double-blind, double-dummy, placebo-controlled trial, 196 subjects received placebo or PM-HDM at 500, 1000, 3000, or 5000 mannan-conjugated therapeutic units (mTU)/mL in 9-arm groups for 4 months. All subjects received 5 SC doses (0.5 ml each) every 30 days plus 0.2 ml SL daily. The primary efficacy outcome was the improvement of titrated nasal provocation tests (NPT) with D. pteronyssinus at baseline and at the end of the study. All adverse events and reactions were recorded and assessed. Secondary outcomes were the combination of symptom and medication scores (CSMS) and serological markers. RESULTS: No moderate or severe adverse reactions were reported. Subjects improving the NPT after treatment ranged from 45% to 62% in active SC, 44% to 61% in active SL and 16% in placebo groups. Statistical differences between placebo and active groups were all significant above 500 mTU, being the highest with 3000 mTU SL (p = 0.004) and 5000 mTU SC (p = 0.011). CSMS improvement over placebo reached 70% (p < 0.001) in active 3000 mTU SC and 40% (p = 0.015) in 5000 mTU SL groups. CONCLUSIONS: PM-HDM immunotherapy was safe and successful in achieving primary and secondary clinical outcomes in SC and SL at either 3000 or 5000 mTU/ml.

Safety evaluation of a multiallergen immunotherapy treatment in polyallergic patients. APOLO observational study.

Aim: Assessment of safety, tolerability and changes in global clinical impression with an multiallergen immunotherapy treatment without dilutional effect in polyallergic patients. Patients & methods: This observational prospective study included patients with allergic rhinitis-rhinoconjunctivitis with or without asthma between 5 and 60 years old receiving immunotherapy treatment with a mixture of two allergenic sources. All adverse events were recorded. Global clinical impression, tolerability subjective assessment and satisfaction were also assessed. Results: 130 patients were analyzed. Nine clinically relevant local adverse reactions were reported in six patients (4.6%). Six systemic reactions (grades 0-I) occurred in four patients (3.1%). Patients improved significantly in their global clinical impression. Good tolerability subjective assessment and satisfaction values were also observed. Conclusion: This multiallergen immunotherapy treatment without dilutional effect can be considered as a potential therapeutic alternative for polyallergic patients suffering from allergic rhinitis.