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      Effectiveness and safety of a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid immunotherapy in adult patients with allergic asthma and rhinitis: A real‐life prospective observational study

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          Abstract

          Introduction

          Although clinical trials have shown the efficacy and safety of allergen‐specific immunotherapy (AIT) in the treatment of allergic asthma, there is a need for real‐life studies. We aimed to assess the effectiveness and safety of a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite (HDM)‐induced allergic asthma in a real‐life study.

          Methods

          A subanalysis of a multicenter, prospective, observational, real‐life study. Patients with rhinitis and allergic asthma caused by HDMs were assessed before AIT with Acarovac Plus® and at 6 and 12 months after this treatment. Assessment parameters were percentage of days with asthma symptoms, percentage of days on asthma medication, classification of asthma according to Spanish guidelines for the management of asthma, asthma‐related quality of life (quality of life in adults with asthma questionnaire [QLAAQ]), perception of symptoms (visual analog scale [VAS]), and treatment satisfaction (treatment satisfaction questionnaire for medication [TSQM]). Safety was assessed by the number and severity of adverse reactions.

          Results

          This subanalysis included 55 patients. Treatment with Acarovac Plus® showed significant differences in the analyzed variables when the baseline visit was compared with the 12‐month visit: reduction of the mean (SD) percentage of days with asthma symptoms (23.9 [9.2] vs. 5.1 [12.8]; p = .002), of the mean [SD] percentage of days on asthma medication (67.6 [42.9] vs. 45.1 [46.8]; p = .002), and of the percentage of patients with persistent asthma (78.2% vs. 38.9%; p = .009). Acarovac Plus® significantly improved asthma‐related quality of life, as shown by a decrease of 1.39 points in QLAAQ score at 12 months ( p < .001), and in the subjective perception of symptoms on the VAS (−3.50, p < .0001). Patients showed high treatment satisfaction according to the TSQM, and it was well tolerated. No serious adverse events were reported.

          Conclusions

          Acarovac Plus® was effective and safe for the treatment of patients with HDM‐induced allergic asthma in a real‐life study.

          Abstract

          In this multicenter, prospective, observational, real‐life study, we assessed the effectiveness and safety of allergen‐specific immunotherapy with a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite‐induced allergic asthma. At 6 and 12 months of treatment, Acarovac Plus® showed a significant clinical improvement assessed by reduction of days with symptoms and need for medication and by improvement in disease severity according to Spanish guidelines for the management of asthma classification and asthma‐related quality of life. All of the above was associated with a good safety profile and a high level of patient satisfaction.

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          Most cited references40

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          Information bias in health research: definition, pitfalls, and adjustment methods

          As with other fields, medical sciences are subject to different sources of bias. While understanding sources of bias is a key element for drawing valid conclusions, bias in health research continues to be a very sensitive issue that can affect the focus and outcome of investigations. Information bias, otherwise known as misclassification, is one of the most common sources of bias that affects the validity of health research. It originates from the approach that is utilized to obtain or confirm study measurements. This paper seeks to raise awareness of information bias in observational and experimental research study designs as well as to enrich discussions concerning bias problems. Specifying the types of bias can be essential to limit its effects and, the use of adjustment methods might serve to improve clinical evaluation and health care practice.
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            Determining a minimal important change in a disease-specific Quality of Life Questionnaire.

            This study was carried out to determine whether the minimal important difference, in evaluative quality of life instruments which use a 7-point scale, is similar across individual domains and for both improvement and deterioration. Thirty nine adults with asthma were studied, using an 8 week cohort with assessments at 0, 4 and 8 weeks. The outcomes were the Asthma Quality of Life Questionnaire and global rating of change. For overall asthma-specific quality of life and for all individual domains (activities, emotions, symptoms), the minimal important difference of quality of life score per item was very close to 0.5 (range: 0.42-0.58); differences of approximately 1.0 represented a moderate change (range: 0.77-1.51); differences greater than 1.5 represented large changes. Changes for improvement and deterioration were very similar. The changes in quality of life score that represent a minimal important difference are very similar to those observed for other evaluative instruments. The observation that the minimal important difference is consistent across domains and for both improvement and deterioration will facilitate interpretation of results of studies examining quality of life.
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              Validation of a standardized version of the Asthma Quality of Life Questionnaire.

              In the original 32-item Asthma Quality of Life Questionnaire (AQLQ), five activity questions are selected by patients themselves. However, for long-term studies and large clinical trials, generic activities may be more appropriate. For the standardized version of the AQLQ, the AQLQ(S), we formulated five generic activities (strenuous exercise, moderate exercise, work-related activities, social activities, and sleep) to replace the five patient-specific activities in the AQLQ. In a 9-week observational study, we compared the AQLQ with the AQLQ(S) and examined their measurement properties. Forty symptomatic adult asthma patients completed the AQLQ(S), the AQLQ, the Medical Outcomes Survey Short Form 36, the Asthma Control Questionnaire, and spirometry at baseline, 1, 5, and 9 weeks. Activity domain scores (mean +/- SD) were lower with the AQLQ (5.7 +/- 0.9) than with the AQLQ(S) (5.9 +/- 0.8; p = 0.0003) and correlation between the two was moderate (r = 0.77). However, for overall scores, there was minimal difference (AQLQ, 5.4 +/- 0.8; AQLQ(S), 5.5 +/- 0.8; r = 0.99). Reliability (AQLQ intraclass correlation coefficient, 0.95; AQLQ(S) intraclass correlation coefficient, 0.96) and responsiveness (AQLQ, p < 0.0001; AQLQ(S), p < 0.0001) were similar for the two instruments. Construct validity (correlation with other measures of health status and clinical asthma) was also similar for the two instruments. The AQLQ(S) has strong measurement properties and is valid for measuring health-related quality of life in asthma. The choice of instrument should depend on the task at hand.
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                Author and article information

                Contributors
                clara.padro.casas@gmail.com
                Journal
                Immun Inflamm Dis
                Immun Inflamm Dis
                10.1002/(ISSN)2050-4527
                IID3
                Immunity, Inflammation and Disease
                John Wiley and Sons Inc. (Hoboken )
                2050-4527
                19 April 2022
                May 2022
                : 10
                : 5 ( doiID: 10.1002/iid3.v10.5 )
                : e585
                Affiliations
                [ 1 ] Allergy Section Hospital Universitari Germans Trias i Pujol Badalona Spain
                [ 2 ] Clínica Médico Asistencial Virgen del Rosario Algeciras Spain
                [ 3 ] CM ASISA Dr. Lobatón Cádiz Spain
                [ 4 ] Allergy Department Complexo Hospitalario Universitario A Coruña A Coruña Spain
                [ 5 ] Allergy Unit Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain
                [ 6 ] Allergy Therapeutics Ibérica Sant Joan Despí Spain
                Author notes
                [*] [* ] Correspondence Clara Padró, Allergy Section, Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, s/n, 08916 Badalona, Spain. 

                Email: clara.padro.casas@ 123456gmail.com

                José L. Justicia and Albert Roger contributed equally to this study.

                Author information
                http://orcid.org/0000-0003-0139-5836
                Article
                IID3585
                10.1002/iid3.585
                9017636
                b72e4b5a-0562-42d4-baf1-762d162874d0
                © 2022 The Authors. Immunity, Inflammation and Disease published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 16 September 2021
                : 18 November 2021
                Page count
                Figures: 3, Tables: 1, Pages: 9, Words: 5987
                Funding
                Funded by: Allergy Therapeutics Ibérica
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                May 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.4 mode:remove_FC converted:19.04.2022

                allergen‐specific immunotherapy,allergic asthma,allergoid,dermatophagoides pteronyssinus,microcrystalline tyrosine,real‐life clinical practice

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