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Health and Quality of Life Outcomes

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Open Access 01-12-2014 | Research

Estimation of health-related utility (EQ-5D index) in subjects with seasonal allergic rhinoconjunctivitis to evaluate health gain associated with sublingual grass allergen immunotherapy

Authors: Chris D Poole, Christian A Bannister, Jakob Nørgaard Andreasen, Jens Strodl Andersen, Craig J Currie

Published in: Health and Quality of Life Outcomes | Issue 1/2014

Abstract

Background

Grass allergen immunotherapy (AIT) reduces symptom severity in seasonal allergic rhinoconjunctivitis (ARC) but its impact on general health-related utility has not been characterised for the purposes of economic evaluation. The aim of this study was to model the preferred measure of utility, EQ-5D index, from symptom severity and estimate incremental quality adjusted life years (QALYs) associated with SQ-standardised grass immunotherapy tablet (GRAZAX®, 75,000 SQ-T/2,800 BAU, ALK, Denmark).

Methods

Data were analysed from five consecutive pollen seasons in a randomised placebo controlled trial of GRAZAX®. Binomial and Gaussian mixed effects modelling related weekly EQ-5D index score to daily symptom and medication scores (DSS & DMS respectively). In turn, daily EQ-5D index was estimated from ARC symptoms and medication use.

Results

DSS and DMS were the principal predictors of ‘perfect’ health (EQ-5D = 1.000; binomial) and ‘imperfect’ health (EQ-5D < 1.000; Gaussian). Each unit increase in DSS and DMS reduced the odds of ‘perfect’ health (EQ-5D = 1.000) by 27% and 16% respectively, and reduced ‘imperfect’ health by 0.17 and 0.13, respectively. Gender remained the only other significant main fixed effect (Male odds ratio [OR] = 1.82). Incremental estimated EQ-5D index utility for GRAZAX® was observed from day -30 to day +70 of the pooled pollen season; mean daily utility for GRAZAX® = 0.938 units (95%CI 0.932-0.943) vs. 0.914 (0.907-0.921) for placebo, an incremental difference of 0.0238 (p < 0.001). This translates into an incremental 0.0324 Quality Adjusted Life Years over the five year study period.

Conclusions

ARC symptoms and medication use are the main predictors of EQ-5D index. The incremental QALYs observed for GRAZAX® may not fully describe the health benefits of this treatment, suggesting that economic modelling may be conservative.

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Bauchau V, Durham SR: Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J 2004, 24(5):758–764. doi:10.1183/09031936.04.00013904CrossRefPubMed

Dahl R, Andersen PS, Chivato T, Valovirta E, de Monchy J: National prevalence of respiratory allergic disorders. Respir Med 2004, 98(5):398–403. doi:10.1016/j.rmed.2003.11.015CrossRefPubMed

Schatz M: A survey of the burden of allergic rhinitis in the USA. Allergy 2007, 62(Suppl 8):9–16. doi:10.1111/j.1398–9995.2007.01548.xCrossRefPubMed

Pitt AD, Smith AF, Lindsell L, Voon LW, Rose PW, Bron AJ: Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire. Ophthalmic Epidemiol 2004, 11(1):17–33. doi:10.1076/opep.11.1.17.26437CrossRefPubMed

HM Treasury: GDP deflators. 2012.

Nathan RA: The burden of allergic rhinitis. Allergy Asthma Proc 2007, 28(1):3–9. doi:10.2500/aap.2007.28.2934CrossRefPubMed

Hellgren J, Cervin A, Nordling S, Bergman A, Cardell LO: Allergic rhinitis and the common cold--high cost to society. Allergy 2010, 65(6):776–783. doi:10.1111/j.1398–9995.2009.02269.xCrossRefPubMed

European Medicines Evaluation Agency: Guideline on the clinical development on products for specific immuno- therapy for the treatment of allergic diseases. London: EuroQol Group. (n.d.). EQ-5D-3L Value sets; 2008.

Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP: Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol 2011, 127(1):64–71. 71.e1–4. doi:10.1016/j.jaci.2010.11.034CrossRefPubMed

10.

Dahl R, Stender A, Rak S: Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis. Allergy 2006, 61(2):185–190. doi:10.1111/j.1398–9995.2005.00949.xCrossRefPubMed

11.

Dahl R, Kapp A, Colombo G, de Monchy JGR, Rak S, Emminger W, Durham SR: Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006, 118(2):434–440. doi:10.1016/j.jaci.2006.05.003CrossRefPubMed

12.

Dahl R, Kapp A, Colombo G, De Monchy JGR, Rak S, Emminger W, Durham SR: Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol 2008, 121(2):512–518. e2. doi:10.1016/j.jaci.2007.10.039CrossRefPubMed

13.

Durham SR, Emminger W, Kapp A, Colombo G, de Monchy JGR, Rak S, Dahl R: Long-term clinical efficacy in grass pollen-induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet. J Allergy Clin Immunol 2010, 125(1):131–138. e1–7. doi:10.1016/j.jaci.2009.10.035CrossRefPubMed

14.

Frølund L, Durham SR, Calderon M, Emminger W, Andersen JS, Rask P, Dahl R: Sustained effect of SQ-standardized grass allergy immunotherapy tablet on rhinoconjunctivitis quality of life. Allergy 2010, 65(6):753–757. doi:10.1111/j.1398–9995.2009.02238.xCrossRefPubMed

15.

Nelson HS, Nolte H, Creticos P, Maloney J, Wu J, Bernstein DI: Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. J Allergy Clin Immunol 2011, 127(1):72–80. 80.e1–2. doi:10.1016/j.jaci.2010.11.035CrossRefPubMed

16.

Coons SJ, Rao S, Keininger DL, Hays RD: A Comparative Review of Generic Quality-of-Life Instruments. Pharmacoeconomics 2000, 17(1):13–35. doi:10.2165/00019053–200017010–00002CrossRefPubMed

17.

Rabin R, Oemar M, Oppe M: EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument. In EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument (The EuroQol Group). Rotterdam: EuroQol Group; 2011:1–23.

18.

Dolan P: Modeling valuations for EuroQol health states. Med Care 1997, 35(11):1095–1108. Retrieved from http://journals.lww.com/lww-medicalcare/Abstract/1997/11000/Modeling_Valuations_for_EuroQol_Health_States.2.aspxCrossRefPubMed

19.

Szende A, Oppe M, Devlin NJ, Group E: EQ-5D Value Sets: Inventory, Comparative Review and User Guide. In EuroQol Group Monographs, Volume 2. Springer; 2006.

20.

Durham SR, Emminger W, Kapp A, de Monchy JGR, Rak S, Scadding GK, Dahl R: SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. J Allergy Clin Immunol 2012, 129(3):717–725. e5. doi:10.1016/j.jaci.2011.12.973CrossRefPubMed

21.

Huang I-C, Frangakis C, Atkinson MJ, Willke RJ, Leite WL, Vogel WB, Wu AW: Addressing ceiling effects in health status measures: a comparison of techniques applied to measures for people with HIV disease. Health Serv Res 2008, 43(1 Pt 1):327–339. doi:10.1111/j.1475–6773.2007.00745.xPubMedCentralPubMed

22.

Li L, Fu AZ: Some methodological issues with the analysis of preference-based EQ-5D index score. Health Serv Outcomes Res Methodol 2009, 9(3):162–176. doi:10.1007/s10742–009–0053–3CrossRef

23.

Pullenayegum EM, Tarride J-E, Xie F, Goeree R, Gerstein HC, O’Reilly D: Analysis of health utility data when some subjects attain the upper bound of 1: are Tobit and CLAD models appropriate? Value Health J Int Soc Pharmacoecon Outcomes Res 2010, 13(4):487–494. doi:10.1111/j.1524–4733.2010.00695.xCrossRef

24.

R Core Development Team: R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing. R Foundation for Statistical Computing; 2013. http://www.r-project.org

25.

Brazier JE, Yang Y, Tsuchiya A, Rowen DL: A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ 2010, 11(2):215–225. doi:10.1007/s10198–009–0168-zCrossRefPubMed

26.

Hernández Alava M, Wailoo AJ, Ara R: Tails from the peak district: adjusted limited dependent variable mixture models of EQ-5D questionnaire health state utility values. Value Health J Int Soc Pharmacoecon Outcomes Res 2012, 15(3):550–561. doi:10.1016/j.jval.2011.12.014CrossRef

27.

Bachert C, Vestenbaek U, Christensen J, Griffiths UK, Poulsen PB: Cost-effectiveness of grass allergen tablet (GRAZAX) for the prevention of seasonal grass pollen induced rhinoconjunctivitis - a Northern European perspective. Clin Exp Allergy 2007, 37(5):772–779. doi:10.1111/j.1365–2222.2007.02706.xCrossRefPubMed

28.

Sullivan PW, Lawrence WF, Ghushchyan V: A National Catalog of Preference-Based Scores for Chronic Conditions in the United States. Medical Care 2005, 43(7):736–749. doi:10.1097/01.mlr.0000172050.67085.4fCrossRefPubMed

29.

Smith AF, Pitt AD, Rodruiguez AE, Alio JL, Marti N, Teus M, Barnes JR: The economic and quality of life impact of seasonal allergic conjunctivitis in a Spanish setting. Ophthalmic Epidemiol 2005, 12(4):233–242. doi:10.1080/09286580590967781CrossRefPubMed

30.

Colás C, Galera H, Añibarro B, Soler R, Navarro A, Jáuregui I, Peláez A: Disease severity impairs sleep quality in allergic rhinitis (The SOMNIAAR study). Clin Exp Allergy 2012, 42(7):1080–1087. doi:10.1111/j.1365–2222.2011.03935.xCrossRefPubMed

31.

Maspero J, Lee BW, Katelaris CH, Potter PC, Cingi C, Lopatin A, Walters RD: Quality of life and control of allergic rhinitis in patients from regions beyond western Europe and the United States. Clin Exp Allergy 2012, 42(12):1684–1696. doi:10.1111/j.1365–2222.2012.04025.xCrossRefPubMed

32.

Stull D, O’Quinn S, Vestenbaek U, Navaratnam P: PRS24 CEILING EFFECTS AND DISCRIMINATION OF TREATMENT BENEFIT FOR PATIENTS WITH LOWER SYMPTOM SEVERITY: MEASUREMENT OF HEALTH UTILITIES IN ALLERGIC RHINITIS. Value in Health 2008, 11(3):A276. doi:10.1016/S1098–3015(10)70872-XCrossRef

33.

Juniper E, Thompson A, Roberts J: Can the standard gamble and rating scale be used to measure quality of life in rhinoconjunctivitis? Comparison with the RQLQ and SF-36. Allergy 2002, 57: 201–206.CrossRefPubMed

34.

Majani G, Biardini I, Giardini A, Senna GE, Minale P, D’Ulisse S, Canonica W: Health-related quality of life assessment in young adults with seasonal allergic rhinitis. Allergy 2001, 56(4):313–317. doi:10.1034/j.1398–9995.2001.00852.xCrossRefPubMed

35.

Whitehurst DGT, Bryan S: Another study showing that two preference-based measures of health-related quality of life (EQ-5D and SF-6D) are not interchangeable But why should we expect them to be? Value in Health 2011, 14(4):531–538. doi:10.1016/j.jval.2010.09.002CrossRefPubMed

36.

Palta M, Chen H-Y, Kaplan RM, Feeny D, Cherepanov D, Fryback DG: Standard error of measurement of 5 health utility indexes across the range of health for use in estimating reliability and responsiveness. Med Decis Making 2011, 31(2):260–269. doi:10.1177/0272989X10380925PubMedCentralCrossRefPubMed

Title: Estimation of health-related utility (EQ-5D index) in subjects with seasonal allergic rhinoconjunctivitis to evaluate health gain associated with sublingual grass allergen immunotherapy
Authors: Chris D Poole
Christian A Bannister
Jakob Nørgaard Andreasen
Jens Strodl Andersen
Craig J Currie
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2014
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/1477-7525-12-99

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Estimation of health-related utility (EQ-5D index) in subjects with seasonal allergic rhinoconjunctivitis to evaluate health gain associated with sublingual grass allergen immunotherapy

Abstract

Background

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

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Abstract

Background

Methods

Results

Conclusions

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