PURPOSE OF REVIEW: To conduct a qualitative comparison between the primary and secondary outcomes used in clinical trials of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) for allergic rhinitis. RECENT FINDINGS: Studies of SCIT and SLIT for allergic rhinitis published up to January 2012 were included in this systematic review. Different ways of defining primary and secondary outcome parameters in studies investigating specific immunotherapy are described. Whereas older studies often use the total symptom score and the total medication score individually for the primary efficacy analysis, more recent studies follow current international recommendations of applying the total combined score as primary outcome measure. Even wider is the range of secondary outcomes in clinical trials with few being validated or standardized. SUMMARY: As already recognized as a major concern in recent literature, standardized and validated primary endpoints are of paramount importance in order to improve the comparability of study results. The lack of consistency in the selection of primary outcome parameters represents a major problem when comparing the same therapeutic intervention. A main point of concern is the absence of validation data for those primary and secondary outcomes selected. In conclusion, the qualitative analysis of well powered studies confirms an urgent call from academics, regulatory agencies and the pharmaceutical industry for validated primary outcome parameters and standardized definitions.
PURPOSE OF REVIEW: To conduct a qualitative comparison between the primary and secondary outcomes used in clinical trials of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) for allergic rhinitis. RECENT FINDINGS: Studies of SCIT and SLIT for allergic rhinitis published up to January 2012 were included in this systematic review. Different ways of defining primary and secondary outcome parameters in studies investigating specific immunotherapy are described. Whereas older studies often use the total symptom score and the total medication score individually for the primary efficacy analysis, more recent studies follow current international recommendations of applying the total combined score as primary outcome measure. Even wider is the range of secondary outcomes in clinical trials with few being validated or standardized. SUMMARY: As already recognized as a major concern in recent literature, standardized and validated primary endpoints are of paramount importance in order to improve the comparability of study results. The lack of consistency in the selection of primary outcome parameters represents a major problem when comparing the same therapeutic intervention. A main point of concern is the absence of validation data for those primary and secondary outcomes selected. In conclusion, the qualitative analysis of well powered studies confirms an urgent call from academics, regulatory agencies and the pharmaceutical industry for validated primary outcome parameters and standardized definitions.
Authors: Giorgio Walter Canonica; Linda Cox; Ruby Pawankar; Carlos E Baena-Cagnani; Michael Blaiss; Sergio Bonini; Jean Bousquet; Moises Calderón; Enrico Compalati; Stephen R Durham; Roy Gerth van Wijk; Désirée Larenas-Linnemann; Harold Nelson; Giovanni Passalacqua; Oliver Pfaar; Nelson Rosário; Dermot Ryan; Lanny Rosenwasser; Peter Schmid-Grendelmeier; Gianenrico Senna; Erkka Valovirta; Hugo Van Bever; Pakit Vichyanond; Ulrich Wahn; Osman Yusuf Journal: World Allergy Organ J Date: 2014-03-28 Impact factor: 4.084
Authors: Oliver Pfaar; Claus Bachert; Albrecht Bufe; Roland Buhl; Christof Ebner; Peter Eng; Frank Friedrichs; Thomas Fuchs; Eckard Hamelmann; Doris Hartwig-Bade; Thomas Hering; Isidor Huttegger; Kirsten Jung; Ludger Klimek; Matthias Volkmar Kopp; Hans Merk; Uta Rabe; Joachim Saloga; Peter Schmid-Grendelmeier; Antje Schuster; Nicolaus Schwerk; Helmut Sitter; Ulrich Umpfenbach; Bettina Wedi; Stefan Wöhrl; Margitta Worm; Jörg Kleine-Tebbe; Susanne Kaul; Anja Schwalfenberg Journal: Allergo J Int Date: 2014
Authors: M A Calderon; P Demoly; T Casale; C A Akdis; C Bachert; M Bewick; B M Bilò; B Bohle; S Bonini; A Bush; D P Caimmi; G W Canonica; V Cardona; A M Chiriac; L Cox; A Custovic; F De Blay; P Devillier; A Didier; G Di Lorenzo; G Du Toit; S R Durham; P Eng; A Fiocchi; A T Fox; R Gerth van Wijk; R M Gomez; T Haathela; S Halken; P W Hellings; L Jacobsen; J Just; L K Tanno; J Kleine-Tebbe; L Klimek; E F Knol; P Kuna; D E Larenas-Linnemann; A Linneberg; M Matricardi; H J Malling; R Moesges; J Mullol; A Muraro; N Papadopoulos; G Passalacqua; E Pastorello; O Pfaar; D Price; P Rodriguez Del Rio; R Ruëff; B Samolinski; G K Scadding; G Senti; M H Shamji; A Sheikh; J C Sisul; D Sole; G J Sturm; A Tabar; R Van Ree; M T Ventura; C Vidal; E M Varga; M Worm; T Zuberbier; J Bousquet Journal: Clin Transl Allergy Date: 2016-11-23 Impact factor: 5.871