Real-life studies in allergen immunotherapy

Passalacqua, Giovanni; Bagnasco, Diego

doi:10.1097/aci.0000000000000757

Cited by 11 publications

(7 citation statements)

References 33 publications

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“…In children, one of these trials additionally showed a reduced risk of experiencing asthma symptoms or using asthma medication while there was no difference in time to onset of asthma during the two-year follow-up period. 43 Data from different real-world settings, for example, non-interventional studies or analyses in claims databases, patients surveys, electronic health records or product and disease registries allow to analyze the effectiveness and medication adherence under practical conditions 10,45 and the evaluation of long-term data for larger patient populations and even longer follow-up periods without the risk of ethical concerns arising from withholding a therapy proven to be effective in placebo groups in 5-years' DBPC AIT studies. This review summarizes results from 13 publications dealing with retrospective cohort assessments of national prescription databases in Europe.…”

Section: Rwd Analyses On Ait Long-term Effectsmentioning

confidence: 99%

Real‐world evidence for the long‐term effect of allergen immunotherapy: Current status on database‐derived European studies

Vogelberg

Klimek

Brüggenjürgen

et al. 2022

Allergy

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Randomized controlled trials (RCTs) are the gold‐standard for benefit–risk assessments during drug approval processes. Real‐word data (RWD) and the resulting real‐world evidence (RWE) are becoming increasingly important for assessing the effectiveness of drug products after marketing authorization showing how RCT results are transferred into real life care. The effectiveness of allergen immunotherapy (AIT) has been assessed in several RWE studies based on large prescription databases. We performed a literature search for retrospective cohort assessments of prescription databases in Europe to provide an overview on the methodology, long‐term effectiveness outcomes, and adherence to AIT. Thirteen respective publications were selected. AIT was more effective in reducing the progression of allergic rhinitis (AR) compared to a non‐AIT control group receiving only symptomatic treatment for AR for up to 6 years. The development and progression of asthma were hampered for most endpoints in patients treated with most preparations compared to the non‐AIT group, receiving only anti‐asthmatic medication. The results for “time to onset” of asthma were inconsistent. Adherence to AIT decreased during the recommended 3‐year treatment period, however, in most studies higher adherence to subcutaneous than to sublingual AIT was shown. The analysis of long‐term effectiveness outcomes of the RWE studies based on prescription databases confirms the long‐term efficacy of AIT demonstrated in RCTs. Progression of rhinitis and asthma symptoms as well as delayed onset of asthma triggered by different allergens, real life adherence to the treatment shows differences in particular application routes.

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Section: Rwd Analyses On Ait Long-term Effectsmentioning

confidence: 99%

Real‐world evidence for the long‐term effect of allergen immunotherapy: Current status on database‐derived European studies

Vogelberg

Klimek

Brüggenjürgen

et al. 2022

Allergy

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show abstract

“…Data from different realworld settings e.g. non-interventional studies or analyses in claims databases, patients surveys, electronic health records or product and disease registries allow to analyze the effectiveness and medication adherence under practical conditions (10,43) and the evaluation of long-term data for larger patient populations and even longer follow-up periods without the risk of ethical concerns arising from withholding a therapy proven to be effective in placebo groups in 5-years' DBPC AIT studies. This review summarizes results from thirteen publications dealing with retrospective cohort assessments of national prescription databases in Europe.…”

Section: Rwd Analyses On Ait Long-term Effectsmentioning

confidence: 99%

Real-world evidence for the long-term effect of allergen immunotherapy: current status on database-derived studies

Vogelberg¹,

Klimek

Brüggenjürgen

et al. 2022

Preprint

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Background: Randomized controlled trials (RCTs) are the gold-standard for benefit-risk assessments during drug approval processes. Real-word data (RWD) and the resulting real-world evidence (RWE) are becoming increasingly important for assessing the effectiveness of drug products after marketing authorization showing how RCT results are transferred into real life care. The effectiveness of allergen immunotherapy (AIT) has been assessed in several RWE studies based on large prescription databases. Methods: We performed a literature search for retrospective cohort assessments of prescription databases in Europe to provide an overview on the methodology, long-term effectiveness outcomes and adherence to AIT. Results: 13 respective publications were selected. AIT was more effective in reducing the progression of allergic rhinitis (AR) compared to a non-AIT control group receiving only symptomatic treatment for AR for up to 6 years. The development and progression of asthma was hampered for most endpoints in patients treated with most preparations compared to the non-AIT group, receiving only anti-asthmatic medication. The results for “time to onset” of asthma were inconsistent. Adherence to AIT decreased during the recommended 3-years treatment period, however in most studies higher adherence to subcutaneous than to sublingual AIT was shown. Conclusion: The analysis of long-term effectiveness outcomes of the RWE studies based on prescription databases confirms the long-term efficacy of AIT demonstrated in RCTs. Progression of rhinitis and asthma symptoms as well as delayed onset of asthma triggered by different allergens, real life adherence to the treatment shows differences in particular application routes.

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“…Furthermore, patient selectivity in randomized clinical trials is difficult to apply to patients in real-life clinical practice, who are only partially represented by the highly selected population of RCTs [12][13][14][15]. It follows that real-life studies are required to confirm the applicability of AIT in common practice [16].…”

Section: Introductionmentioning

confidence: 99%

“…In recent years, real-life studies have been performed for AIT, demonstrating its effectiveness and safety and ensuring a better understanding of the best candidates for this therapy [16], thus leading to more widespread and appropriate AIT use. The importance of real-life studies has now been realized, and it has been recommended that real-life trials be conducted, suggesting that such studies should be introduced in the major EBM validation process for each individual product [17,18].…”

Section: Introductionmentioning

confidence: 99%

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Real-Life Effectiveness of Subcutaneous Immune Therapy with Carbamylated Monomeric Allergoids on Mite, Grass, and Pellitory Respiratory Allergy: A Retrospective Study

Gioacchino

Valle

Mangifesta

et al. 2022

JCM

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Background: real-life studies are encouraged to evaluate the effectiveness and safety of allergen immunotherapy (AIT). In this context, a retrospective cohort study was conducted to assess the effectiveness and safety of carbamylated monomeric allergoid subcutaneous immunotherapy (MA-SCIT), along with patient satisfaction. Methods: a total of 291 patients with rhinoconjunctivitis with or without asthma with inhalant (house dust mite, grass, and pellitory) allergies were enrolled in this study. Perceived efficacy and perceived satisfaction with MA-SCIT, symptom score by VAS, ARIA classification of rhinitis, drug consumption, number of asthma worsening episodes, and asthma symptom control were evaluated by questionnaires before, after one year, at the end of treatment, and after one or two years of MA-SCIT. Results: the overall symptom score significantly decreased over the years of MA-SCIT, irrespective of specific sensitization (p < 0.01). There was a substantial amelioration of rhinitis severity, with a significant reduction (p < 0.01) in drug use. A significant reduction was observed in the asthma symptom VAS score and asthma-worsening episodes requiring systemic steroids. None of the patients reported any severe adverse reactions. Finally, 90% of the patients reported full satisfaction with the treatment. Conclusions: the study showed that AIT with carbamylated monomeric allergoids of grass, pellitory, and mites was effective and well tolerated by patients.

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Real-life studies in allergen immunotherapy

Cited by 11 publications

References 33 publications

Real‐world evidence for the long‐term effect of allergen immunotherapy: Current status on database‐derived European studies

Real‐world evidence for the long‐term effect of allergen immunotherapy: Current status on database‐derived European studies

Real-world evidence for the long-term effect of allergen immunotherapy: current status on database-derived studies

Real-Life Effectiveness of Subcutaneous Immune Therapy with Carbamylated Monomeric Allergoids on Mite, Grass, and Pellitory Respiratory Allergy: A Retrospective Study

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