Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles

[1]  D. Bernstein,et al.  Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. , 2016, The Journal of allergy and clinical immunology.

[2]  S. Durham,et al.  Treatment effect of sublingual immunotherapy tablets and pharmacotherapies for seasonal and perennial allergic rhinitis: Pooled analyses. , 2016, The Journal of allergy and clinical immunology.

[3]  J. Virchow,et al.  Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma: A Randomized Clinical Trial. , 2016, JAMA.

[4]  V. Backer,et al.  Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial. , 2016, The Journal of allergy and clinical immunology.

[5]  D. Bernstein,et al.  Efficacy and Safety of the SQ-House Dust Mite Sublingual Immunotherapy Tablet in North American Children and Adults: Findings from a Large Randomized, Placebo-Controlled Clinical Trial , 2016 .

[6]  S. Durham,et al.  Safety of sublingual immunotherapy Timothy grass tablet in subjects with allergic rhinitis with or without conjunctivitis and history of asthma , 2015, Allergy.

[7]  S. Vieths,et al.  Environmental exposure chambers in allergen immunotherapy trials: Current status and clinical validation needs. , 2015, The Journal of allergy and clinical immunology.

[8]  R. Gerth van Wijk,et al.  Mite-Allergic Rhinitis: How to Evaluate Clinical Efficacy in Allergen-Specific Immunotherapy Trials? , 2015, Current Treatment Options in Allergy.

[9]  E. Vicaut,et al.  The minimally important difference in the Rhinoconjunctivitis Total Symptom Score in grass‐pollen‐induced allergic rhinoconjunctivitis , 2014, Allergy.

[10]  M. Blaiss,et al.  A comparative analysis of symptom and medication scoring methods used in clinical trials of sublingual immunotherapy for seasonal allergic rhinitis , 2014, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

[11]  P. Demoly,et al.  Rhinitis , sinusitis , and upper airway disease Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis , 2016 .

[12]  J. Bousquet,et al.  Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. , 2014, Allergy.

[13]  J. Bousquet,et al.  Sublingual immunotherapy: World Allergy Organization position paper 2013 update , 2014, The World Allergy Organization journal.

[14]  S. Durham,et al.  Magnitude of efficacy measurements in grass allergy immunotherapy trials is highly dependent on pollen exposure , 2014, Allergy.

[15]  D. Gentile,et al.  Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis. , 2014, The Journal of allergy and clinical immunology.

[16]  D. Bernstein,et al.  Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. , 2014, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[17]  J. Bousquet,et al.  Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language. , 2013, The Journal of allergy and clinical immunology.

[18]  C. Baena-Cagnani,et al.  Pediatric sublingual immunotherapy efficacy: evidence analysis, 2009-2012. , 2013, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[19]  T. Casale,et al.  Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. , 2013, The Journal of allergy and clinical immunology.

[20]  A. Meadows,et al.  Subcutaneous and sublingual immunotherapy for seasonal allergic rhinitis: a systematic review and indirect comparison. , 2013, The Journal of allergy and clinical immunology.

[21]  A. Bufe,et al.  Die klinische Wirksamkeit und immunologische Antwort einer SQ-standardisierten Gras-Allergie-Immuntherapie- Tablette (AIT) ist nach einer Behandlungssaison vergleichbar zwischen Kindern und Erwachsenen Post-hoc- Analyse zwei randomisierter Studien , 2013 .

[22]  T. Casale,et al.  Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. , 2012, The Journal of allergy and clinical immunology.

[23]  S. Durham,et al.  Allergen immunotherapy for allergic respiratory diseases , 2012, Human vaccines & immunotherapeutics.

[24]  N. Zhong,et al.  Specific IgG4 Production during House Dust Mite Immunotherapy among Age, Gender and Allergic Disease Populations , 2012, International Archives of Allergy and Immunology.

[25]  U. Wahn,et al.  Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy , 2012, Clinical and Translational Allergy.

[26]  I. Annesi-Maesano,et al.  The Burden Associated with Ocular Symptoms in Allergic Rhinitis , 2012, International Archives of Allergy and Immunology.

[27]  P. Demoly,et al.  Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile , 2012, Allergy.

[28]  W. Busse,et al.  Asthma outcomes workshop: overview. , 2012, The Journal of allergy and clinical immunology.

[29]  O. Pfaar,et al.  A randomized placebo‐controlled trial of rush preseasonal depigmented polymerized grass pollen immunotherapy * , 2012, Allergy.

[30]  P. Howarth,et al.  How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA‐GA2LEN statement , 2011, Allergy.

[31]  D. Bernstein,et al.  Systemic reactions to subcutaneous allergen immunotherapy. , 2011, Immunology and allergy clinics of North America.

[32]  K. Hörmann,et al.  Allergen-specific immunotherapy: which outcome measures are useful in monitoring clinical trials? , 2011, Immunology and allergy clinics of North America.

[33]  M. Blaiss,et al.  Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. , 2011, The Journal of allergy and clinical immunology.

[34]  R. Lockey,et al.  Speaking the same language: The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. , 2010, The Journal of allergy and clinical immunology.

[35]  J. Bousquet,et al.  Recommendations for appropriate sublingual immunotherapy clinical trials. , 2009, The Journal of allergy and clinical immunology.

[36]  Jeong-Whun Kim,et al.  Early Compliance and Efficacy of Sublingual Immunotherapy in Patients with Allergic Rhinitis for House Dust Mites , 2009, Clinical and experimental otorhinolaryngology.

[37]  I. Pavord,et al.  An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. , 2009, American journal of respiratory and critical care medicine.

[38]  J Bousquet,et al.  Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce , 2007, Allergy.

[39]  H. Malling.  Sublingual immunotherapy: efficacy – methodology and outcome of clinical trials , 2006, Allergy.

[40]  J. Portnoy,et al.  Evidence-based strategies for treatment of allergic rhinitis , 2004, Current allergy and asthma reports.

[41]  S. Durham,et al.  Induction of IL-10+CD4+CD25+ T cells by grass pollen immunotherapy. , 2003, The Journal of allergy and clinical immunology.

[42]  Marek Jutel,et al.  IL‐10 and TGF‐β cooperate in the regulatory T cell response to mucosal allergens in normal immunity and specific immunotherapy , 2003, European journal of immunology.

[43]  C. Akdis,et al.  Role of interleukin 10 in specific immunotherapy. , 1998, The Journal of clinical investigation.

[44]  H.-J. Mailing.  Immunotherapy as an effective tool in allergy treatment , 1998 .

[45]  R. Lockey,et al.  World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? , 2017, The journal of allergy and clinical immunology. In practice.

[46]  T. Casale,et al.  Epinephrine Use in Clinical Trials of Sublingual Immunotherapy Tablets. , 2017, The journal of allergy and clinical immunology. In practice.

[47]  S. Durham,et al.  Originalarbeit Clinical efficacy and immunological response in children is similar to that of adults after the first treatment season with SQ-standardized grass allergy immunotherapy tablet in two randomized trials , 2013 .

[48]  D. Bernstein,et al.  Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. , 2011, The Journal of allergy and clinical immunology.

[49]  J. Wernicke,et al.  Detecting Treatment Emergent Adverse Events in Clinical Trials , 2005, Drug safety.

[50]  H. Malling.  Immunotherapy as an effective tool in allergy treatment. , 1998, Allergy.