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      Patient related outcomes in a real life prospective follow up study: Allergen immunotherapy increase quality of life and reduce sick days

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          Abstract

          Background

          One fourth of the adult population in Europe suffer from respiratory allergy. Subcutaneous-allergen-specific-immunotherapy (SCIT) has long-term disease modifying effect on disease specific Health-Related Quality of Life (HRQoL). The purpose of this study was to assess the effect of SCIT on alternative disease outcomes in patients with grass-pollen and/or house dust mite induced allergic rhino-conjunctivitis and/or an asthma diagnosis. Focus was on expressing outcomes in terms of generic quality of life (Quality-Adjusted-Life-Years (QALY)) and reductions in sick days.

          Methods

          The study was a multi-centre study with prospective follow-up. 248 patients were initiated on SCIT. The disease specific Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) and two generic (HRQoL) instruments 15D and EQ-5D were used at baseline and at follow-up. The outcome measures included change in; disease severity, RQLQ-scores, number of days with symptoms- and number of sick days per year and finally changes in generic HRQoL and thus, QALY. Disease severity was assessed by specialist doctors; severity of rhino-conjunctivitis was classified according to the Allergic Rhinitis and its Impact on Asthma (ARIA) and asthma severity according to the Global Initiative for Asthma (GINA guideline). The remaining outcome measures were assessed by the patients in questionnaires at baseline and at follow-up. An intension to treat approach was applied. For missing items imputation of sample mean base-line values or follow-up values were used after specified criteria. The effect of SCIT on rhino-conjunctivitis and/or asthma diagnoses was analysed at follow-up using three logistic regression models.

          Results

          The disease severity showed significantly improved disease control. Mean RQLQ-score was reduced from 3.02 at baseline to 2.00 at follow-up. Average annual days with symptoms were reduced from 189 to 145 days whilst annual sick days were reduced from 3.7 to 1.2 days. The 15D-score increased from 0.83 to 0.86 and the EQ-5D-score from 0.70 to 0.77, which indicated an annual gain per patient of 0.03-0.06 QALY.

          Conclusions

          Allergic patients suffering from rhino-conjunctivitis alone or rhino-conjunctivitis and asthma experience significantly increased HRQoL and they gain 0.03-0.06 QALY, when treated with SCIT for one year.

          Trial registration

          The study was registered at ClinicalTrials.gov with the identifier: NCT01486498.

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          Most cited references23

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          Long-term clinical efficacy of grass-pollen immunotherapy.

          Pollen immunotherapy is effective in selected patients with IgE-mediated seasonal allergic rhinitis, although it is questionable whether there is long-term benefit after the discontinuation of treatment. We conducted a randomized, double-blind, placebo-controlled trial of the discontinuation of immunotherapy for grass-pollen allergy in patients in whom three to four years of this treatment had previously been shown to be effective. During the three years of this trial, primary outcome measures were scores for seasonal symptoms and the use of rescue medication. Objective measures included the immediate conjunctival response and the immediate and late skin responses to allergen challenge. Cutaneous-biopsy specimens obtained 24 hours after intradermal allergen challenge were examined for T-cell infiltration and the presence of cytokine-producing T helper cells (TH2 cells) (as evidenced by the presence of interleukin-4 messenger RNA). A matched group of patients with hay fever who had not received immunotherapy was followed as a control for the natural course of the disease. Scores for seasonal symptoms and the use of rescue antiallergic medication, which included short courses of prednisolone, remained low after the discontinuation of immunotherapy, and there was no significant difference between patients who continued immunotherapy and those who discontinued it. Symptom scores in both treatment groups (median areas under the curve in 1995, 921 for continuation of immunotherapy and 504 for discontinuation of immunotherapy; P=0.60) were markedly lower than those in the group that had not received immunotherapy (median value in 1995, 2863). Although there was a tendency for immediate sensitivity to allergen to return late after discontinuation, there was a sustained reduction in the late skin response and associated CD3+ T-cell infiltration and interleukin-4 messenger RNA expression. Immunotherapy for grass-pollen allergy for three to four years induces prolonged clinical remission accompanied by a persistent alteration in immunologic reactivity.
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            Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study.

            3-year subcutaneous specific immunotherapy (SIT) in children with seasonal allergic rhinoconjunctivitis reduced the risk of developing asthma during treatment and 2 years after discontinuation of SIT (5-year follow-up) indicating long-term preventive effect of SIT. We evaluated the long-term clinical effect and the preventive effect of developing asthma 7-years after termination of SIT. One hundred and forty-seven subjects, aged 16-25 years with grass and/or birch pollen allergy was investigated 10 years after initiation of a 3-year course of SIT with standardized allergen extracts of grass and/or birch or no SIT respectively. Conjunctival provocations were performed outside the season and methacholine bronchial provocations were performed during the season and winter. Asthma was assessed by clinical evaluation. The significant improvements in rhinoconjunctivitis and conjunctival sensitivity persisted at the 10-year follow-up. Significantly less actively treated subjects had developed asthma at 10-year follow-up as evaluated by clinical symptoms [odds ratio 2.5 (1.1-5.9)]. Patients who developed asthma among controls were 24/53 and in the SIT group 16/64. The longitudinal treatment effect when adjusted for bronchial hyper-responsiveness and asthma status at baseline including all observations at 3, 5 and 10 years follow-up (children with or without asthma at baseline, n = 189; 511 observations) was statistically significant (P = 0.0075). The odds ratio for no-asthma was 4.6 95% CI (1.5-13.7) in favor of SIT. A 3-year course of SIT with standardized allergen extracts has shown long-term clinical effects and the potential of preventing development of asthma in children with allergic rhinoconjunctivitis up to 7 years after treatment. Specific immunotherapy has long-term clinical effects and the potential of preventing development of asthma in children with allergic rhino conjunctivitis up to 7 years after treatment termination.
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              Generation of a Danish TTO value set for EQ-5D health states.

              Health policy decisions should be based on national social preferences. In the absence of a set of Danish health preferences, patient outcome studies using the EQ-5D instrument have typically used UK health state valuations. This article describes the development of a Danish EQ-5D value set. Regression modelling was based on Time Trade-Off (TTO) data derived from computer-assisted interviews conducted with 1,332 respondents from the Danish general population. Using a split-sample technique, 46 health states were directly valued by the respondents. Five different model types were tested and compared on statistical and theoretical grounds. Eleven different specifications were then tested for the chosen model type to identify the most appropriate model that had high explanatory power and parameters that were both consistent (positively signed) and statistically significant. An additive random effects model was found to be superior to ordinary least squares, fixed effects, random coefficient and censored Tobit modelling approaches. From the 11 model specifications tested, the TTO3 model (main effects model, without an N3 factor) performed best and was used to generate a Danish set of health state preferences. An additive random effects model appears to adequately generate a Danish set of EQ-5D health state preferences. The model has high explanatory power and produces consistent and significant parameters for EQ-5D dimensions and levels. It is recommended that this value set be used in Danish cost-utility studies using EQ-5D.
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                Author and article information

                Contributors
                Journal
                World Allergy Organ J
                World Allergy Organ J
                The World Allergy Organization Journal
                World Allergy Organization
                1939-4551
                2013
                9 September 2013
                : 6
                : 1
                : 15
                Affiliations
                [1 ]Danish Center for Healthcare Improvements (DCHI), Faculty of Social Sciences and Faculty of Health Sciences, Department of Business and Management, Aalborg University, Fibigerstræde 11, 11-75, 9220 Aalborg Ø, Denmark
                [2 ]Centre of Health Economics Research (COHERE), University of Southern Denmark, Odense, Denmark
                [3 ]Department of Research & Development, ALK-Abelló, Hørsholm, Denmark
                [4 ]Institute for Clinical Medicine, Aarhus Universitet, Brendstrupgårdsvej 100, DK 8200 Aarhus N, Denmark
                Article
                1939-4551-6-15
                10.1186/1939-4551-6-15
                3846409
                24229439
                35c1f527-179e-4ac0-9e40-6a1723f58bef
                Copyright © 2013 Petersen et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 April 2013
                : 16 July 2013
                Categories
                Original Research

                Immunology
                allergic,rhinitis,asthma,health related quality of life,sick leave,absenteeism,house dust mite allergy,immunotherapy,pollen allergy,quality adjusted,life years,rhino-conjunctivitis,15d,eq-5d

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