Allergen-Specific Immunotherapy: Which Outcome Measures are Useful in Monitoring Clinical Trials?

Background: Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints. Methods: As elaborated by a Task Force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results: Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score (CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion: A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis.

show abstract

“…However, the definition of the 'clinically justified threshold' symptom score is heterogeneous between different trials (8).…”

Section: Well and Severe Daysmentioning

confidence: 99%

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Pfaar

Démoly

Wijk

et al. 2014

Allergy

Self Cite

376

442

View full text Add to dashboard Cite

show abstract

“…minimal amount of airborne pollen that is necessary to trigger a nasal or conjunctival allergic reaction) has not yet been defined throughout the literature (12). Moreover, such a definition must be a compromise as it is known that the threshold of pollen exposure for symptoms in allergic individuals may vary widely (8). A first review of attempts to correlate exposure to symptoms was conducted under the European Cooperation in the field of Scientific and Technical Research (COST) action ES0603 (13,14).…”

mentioning

confidence: 99%

Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen‐induced rhinoconjunctivitis – an EAACI position paper

Pfaar

Bastl

Berger

et al. 2017

Allergy

Self Cite

139

155

View full text Add to dashboard Cite

Underlying principles in measuring pollen exposure and associated methodological problems and limitations were considered to achieve a consensus. Results: The Task Force achieved a comprehensive position in defining pollen exposure times for different pollen types. Definitions are presented for 'pollen season', 'high pollen season' (or 'peak pollen period') and 'high pollen days'. Conclusion: This EAACI position paper provides definitions of pollen exposures for different pollen types for use in AIT trials. Their validity as standards remains to be tested in future studies.

show abstract

“…Подсчет количества дней с/без симптомов осущест-влялся и ранее в достаточно большом количестве иссле-дований [27, 30-32, 52, 53], однако результаты «клини-чески допустимой величины» критерия неоднородны [54]. При этом надо отметить, что перспективы использования подсчета «хороших/плохих» дней сохраняются: по данным RQLQ установлена прямая корреляция между количе-ством дней с выраженными симптомами и низким каче-ством жизни [8].…”

Section: провокационные тесты с аллергенамиunclassified

Allergen-Specific Immunotherapy in Children. Standardizing the Efficacy Evaluation Approaches

Вишнева¹,

Намазова-баранова²,

Алексеева³

et al. 2015

PPh

View full text Add to dashboard Cite

Allergen-Specific Immunotherapy: Which Outcome Measures are Useful in Monitoring Clinical Trials?

Cited by 49 publications

References 91 publications

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen‐induced rhinoconjunctivitis – an EAACI position paper

Allergen-Specific Immunotherapy in Children. Standardizing the Efficacy Evaluation Approaches

Contact Info

Product

Resources

About