title: How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement.
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.
authors.affiliation: University Hospital, Hôpital Arnaud de Villeneuve, Montpellier, France. jean.bousquet@inserm.fr
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: H J
authors.initials: HJ
authors.lastname: Schünemann
authors.forename: P J
authors.initials: PJ
authors.lastname: Bousquet
authors.forename: C
authors.initials: C
authors.lastname: Bachert
authors.forename: G W
authors.initials: GW
authors.lastname: Canonica
authors.forename: T B
authors.initials: TB
authors.lastname: Casale
authors.forename: P
authors.initials: P
authors.lastname: Demoly
authors.forename: S
authors.initials: S
authors.lastname: Durham
authors.forename: K-H
authors.initials: KH
authors.lastname: Carlsen
authors.forename: H-J
authors.initials: HJ
authors.lastname: Malling
authors.forename: G
authors.initials: G
authors.lastname: Passalacqua
authors.forename: F E R
authors.initials: FE
authors.lastname: Simons
authors.forename: J
authors.initials: J
authors.lastname: Anto
authors.forename: C E
authors.initials: CE
authors.lastname: Baena-Cagnani
authors.forename: K-C
authors.initials: KC
authors.lastname: Bergmann
authors.forename: T
authors.initials: T
authors.lastname: Bieber
authors.forename: A H
authors.initials: AH
authors.lastname: Briggs
authors.forename: J
authors.initials: J
authors.lastname: Brozek
authors.forename: M A
authors.initials: MA
authors.lastname: Calderon
authors.forename: R
authors.initials: R
authors.lastname: Dahl
authors.forename: P
authors.initials: P
authors.lastname: Devillier
authors.forename: R
authors.initials: R
authors.lastname: Gerth van Wijk
authors.forename: P
authors.initials: P
authors.lastname: Howarth
authors.forename: D
authors.initials: D
authors.lastname: Larenas
authors.forename: N G
authors.initials: NG
authors.lastname: Papadopoulos
authors.forename: P
authors.initials: P
authors.lastname: Schmid-Grendelmeier
authors.forename: T
authors.initials: T
authors.lastname: Zuberbier
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology; D000818:Animals; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D006801:Humans; D007279:Injections, Subcutaneous; D008925:Mites / Q000276:immunology; D011058:Pollen / Q000276:immunology; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000485:Allergens