SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial
Stephen R. Durham,W. Emminger,Alexander Kapp,Jan G.R. de Monchy,Sabina Rak,Glenis Scadding,Peter Adler Würtzen,Jens Strodl Andersen,Bente Tholstrup,Bente Riis,Ronald Dahl +10 more
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TLDR
In this article, the authors investigated sustained efficacy and disease modification in a 5-year double-blind, placebo-controlled trial, including 2 years of blinded follow-up after completion of a 3-year period of treatment, with the SQ-standardized grass allergy immunotherapy tablet, Grazax ( Phleum pratense 75,000 SQ-T/2,800 BAU, ∗ ∗SQ-T (standardized quality tablet units) and BAU (biological activity units) are quantitative measures of biological activity; i.e.Abstract:
Background The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials. Objective To investigate sustained efficacy and disease modification in a 5-year double-blind, placebo-controlled trial, including 2 years of blinded follow-up after completion of a 3-year period of treatment, with the SQ-standardized grass allergy immunotherapy tablet, Grazax ( Phleum pratense 75,000 SQ-T/2,800 BAU, ∗ ∗SQ-T (standardized quality tablet units) and BAU (biological activity units) are quantitative measures of biological activity; ie, the potency of allergen extracts/vaccines. One grass AIT contains 75,000 SQ-T of timothy (Phleum pratense) grass pollen extract (measure of total biological potency using ALK in-house reference), equivalent to 2,800 BAU (measure of total biological potency, defined by the FDA). ALK, Denmark) or placebo. Methods A randomized, double-blind, placebo-controlled, multinational, phase III trial included adults with a history of moderate-to-severe grass pollen–induced allergic rhinoconjunctivitis, with or without asthma, inadequately controlled by symptomatic medications. Two hundred thirty-eight participants completed the trial. End points included rhinoconjunctivitis symptom and medication scores, combined scores, asthma symptom and medication scores, quality of life, days with severe symptoms, immunologic end points, and safety parameters. Results The mean rhinoconjunctivitis daily symptom score was reduced by 25% to 36% ( P ≤ .004) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial. The rhinoconjunctivitis DMS was reduced by 20% to 45% ( P ≤ .022 for seasons 1-4; P = .114 for season 5), and the weighted rhinoconjunctivitis combined score was reduced by 27% to 41% ( P ≤ .003) in favor of active treatment. The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group, with relative differences of 49% to 63% ( P ≤ .0001). Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response. No safety issues were identified. Conclusion The results confirm disease modification by SQ-standardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis.read more
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Journal ArticleDOI
Sublingual immunotherapy: World Allergy Organization position paper 2013 update
Giorgio Walter Canonica,Linda Cox,Ruby Pawankar,Carlos E. Baena-Cagnani,Michael S. Blaiss,Sergio Bonini,Jean Bousquet,Moises A. Calderon,Enrico Compalati,Stephen R. Durham,Roy Gerth van Wijk,Désirée Larenas-Linnemann,Harold S. Nelson,Giovanni Passalacqua,Oliver Pfaar,Nelson Rosario,Dermot Ryan,Lanny J. Rosenwasser,Peter Schmid-Grendelmeier,Gianenrico Senna,Erkka Valovirta,Hugo Van Bever,Pakit Vichyanond,Ulrich Wahn,Osman M. Yusuf +24 more
TL;DR: “Raising public awareness about sublingual immunotherapy”, as a need for patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion are reported in detail.
Journal ArticleDOI
EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis
Graham Roberts,Graham Roberts,Graham Roberts,Oliver Pfaar,Cezmi A. Akdis,I. J. Ansotegui,Stephen R. Durham,R. Gerth van Wijk,Susanne Halken,Désirée Larenas-Linnemann,Ruby Pawankar,Constantinos Pitsios,Aziz Sheikh,Margitta Worm,Stefania Arasi,Stefania Arasi,Moises A. Calderon,Cemal Cingi,S. Dhami,Jean-Luc Fauquert,Eckard Hamelmann,P W Hellings,Lars Jacobsen,Edward F. Knol,Sandra Y. Lin,P. Maggina,Ralph Mösges,J. N. G. Oude Elberink,Giovanni B. Pajno,Elideanna Pastorello,Martin Penagos,G. Rotiroti,Carsten B. Schmidt-Weber,Frans Timmermans,Olympia Tsilochristou,Eva-Maria Varga,Jamie Wilkinson,Andrew James Williams,Lewei Zhang,Ioana Agache,E. Angier,Montserrat Fernandez-Rivas,Marek Jutel,Steffen Lau,R. van Ree,Dermot Ryan,Gunter J. Sturm,Antonella Muraro +47 more
TL;DR: In general, broad evidence for the clinical efficacy of AIT for AR exists but a product‐specific evaluation of evidence is recommended, and SCIT and SLIT are recommended for both seasonal and perennial AR for its short‐term benefit.
Journal ArticleDOI
Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report.
A.W. Burks,Moises A. Calderon,Thomas B. Casale,Linda Cox,Pascal Demoly,Marek Jutel,Harold S. Nelson,Cezmi A. Akdis +7 more
TL;DR: An expert team was nominated to develop a comprehensive consensus report on the mechanisms of AIT and its use in clinical practice, as well as unmet needs and ongoing developments in AIT.
Journal ArticleDOI
International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.
Sarah K. Wise,Sandra Y. Lin,Elina Toskala,Richard R. Orlandi,Cezmi A. Akdis,Jeremiah A. Alt,Antoine Azar,Fuad M. Baroody,Claus Bachert,G. Walter Canonica,Thomas Chacko,Cemal Cingi,Giorgio Ciprandi,Jacquelynne P. Corey,Linda Cox,Peter S. Creticos,Adnan Custovic,Cecelia Damask,Adam S. DeConde,John M. DelGaudio,Charles S. Ebert,Jean Anderson Eloy,Carrie E. Flanagan,Wytske Fokkens,Christine B. Franzese,Jan Gosepath,Ashleigh A. Halderman,Robert G. Hamilton,Hans Jürgen Hoffman,Jens M. Hohlfeld,Steven M. Houser,Peter H. Hwang,Cristoforo Incorvaia,Deborah Jarvis,Ayesha N. Khalid,Maritta Kilpeläinen,Todd T. Kingdom,Helene J. Krouse,Désirée Larenas-Linnemann,Adrienne M. Laury,Stella E. Lee,Joshua M. Levy,Amber U Luong,Bradley F. Marple,Edward D. McCoul,K. Christopher McMains,Erik Melén,James W. Mims,Gianna Moscato,Joaquim Mullol,Harold S. Nelson,Monica O. Patadia,Ruby Pawankar,Oliver Pfaar,Michael P. Platt,William R. Reisacher,Carmen Rondon,Luke Rudmik,Matthew W. Ryan,Joaquín Sastre,Rodney J. Schlosser,Russell A Settipane,Hemant Sharma,Aziz Sheikh,Timothy L. Smith,Pongsakorn Tantilipikorn,Jody R. Tversky,Maria C Veling,De Yun Wang,Marit Westman,Magnus Wickman,Mark A. Zacharek +71 more
TL;DR: To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR).
Journal ArticleDOI
Clinical practice. Allergic rhinitis.
Lisa M. Wheatley,Alkis Togias +1 more
TL;DR: A 35-year-old woman has a history of nasal congestion on most days of the year, dating back to her late teens; at these times, she also has sneezing, nasal itching, and cough.
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