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How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement

How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement
How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement
Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom-medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs
immunotherapy, randomized controlled trials, rhinitis, subcutaneous, sublingual, symptom score
0105-4538
765-774
Bousquet, J.
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Schünemann, H.J.
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Bousquet, P.J.
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Bachert, C.
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Canonica, G.W.
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Casale, T.B.
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Demoly, P.
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Durham, S.
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Carlsen, K.-H.
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Malling, H.-J.
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Passalacqua, G.
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Simons, F.E.R.
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Anto, J.
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Baena-Cagnani, C.E.
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Bergmann, K.-C.
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Bieber, T.
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Briggs, A.H.
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Brozek, J.
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Calderon, M.A.
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Dahl, R.
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Devillier, P.
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Gerth van Wijk, R.
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Howarth, P.
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Larenas, D.
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Papadopoulos, N.G.
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Schmid-Grendelmeier, P.
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Zuberbier, T.
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Bousquet, J.
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Schünemann, H.J.
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Bousquet, P.J.
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Bachert, C.
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Canonica, G.W.
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Casale, T.B.
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Demoly, P.
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Durham, S.
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Carlsen, K.-H.
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Malling, H.-J.
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Passalacqua, G.
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Simons, F.E.R.
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Anto, J.
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Baena-Cagnani, C.E.
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Bergmann, K.-C.
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Bieber, T.
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Briggs, A.H.
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Brozek, J.
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Calderon, M.A.
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Dahl, R.
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Devillier, P.
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Gerth van Wijk, R.
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Howarth, P.
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Larenas, D.
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Papadopoulos, N.G.
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Schmid-Grendelmeier, P.
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Zuberbier, T.
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Bousquet, J., Schünemann, H.J., Bousquet, P.J., Bachert, C., Canonica, G.W., Casale, T.B., Demoly, P., Durham, S., Carlsen, K.-H., Malling, H.-J., Passalacqua, G., Simons, F.E.R., Anto, J., Baena-Cagnani, C.E., Bergmann, K.-C., Bieber, T., Briggs, A.H., Brozek, J., Calderon, M.A., Dahl, R., Devillier, P., Gerth van Wijk, R., Howarth, P., Larenas, D., Papadopoulos, N.G., Schmid-Grendelmeier, P. and Zuberbier, T. (2011) How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement. Allergy, 66 (6), 765-774. (doi:10.1111/j.1398-9995.2011.02590.x). (PMID:21496059)

Record type: Article

Abstract

Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom-medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs

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e-pub ahead of print date: 18 April 2011
Published date: June 2011
Keywords: immunotherapy, randomized controlled trials, rhinitis, subcutaneous, sublingual, symptom score
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 337427
URI: https://eprints.soton.ac.uk/id/eprint/337427
ISSN: 0105-4538
PURE UUID: c474558e-a88b-405d-86d3-7393f81c01ca

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Date deposited: 26 Apr 2012 08:38
Last modified: 16 Apr 2019 16:31

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Contributors

Author: J. Bousquet
Author: H.J. Schünemann
Author: P.J. Bousquet
Author: C. Bachert
Author: G.W. Canonica
Author: T.B. Casale
Author: P. Demoly
Author: S. Durham
Author: K.-H. Carlsen
Author: H.-J. Malling
Author: G. Passalacqua
Author: F.E.R. Simons
Author: J. Anto
Author: C.E. Baena-Cagnani
Author: K.-C. Bergmann
Author: T. Bieber
Author: A.H. Briggs
Author: J. Brozek
Author: M.A. Calderon
Author: R. Dahl
Author: P. Devillier
Author: R. Gerth van Wijk
Author: P. Howarth
Author: D. Larenas
Author: N.G. Papadopoulos
Author: P. Schmid-Grendelmeier
Author: T. Zuberbier

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