Safety and treatment compliance of subcutaneous immunotherapy: A 30-year retrospective study

Bona, Danilo Di; Magistà, Stefania; Masciopinto, Lucia; Lovecchio, Antonia; Loiodice, Roberto; Bilancia, Massimo; Albanesi, Marcello; Caiaffa, Maria Filomena; Nettis, Eustachio; Macchia, Luigi; Bariletto, G.; Carbonara, Annamaria; Cataldo, Vito; Damiani, Elisabetta; Leo, Elisabetta; Fiorino, Irene; Kourtis, Georgios; Laudadio, Valentina; Loconte, Filomena; Lotti, Anita; Mastromarco, Enza; Nenna, Saverio; Nico, Andrea; Pietrafesa, Maria; Rucco, Anna Simona; Strada, Silvana

doi:10.1016/j.rmed.2019.105843

Cited by 25 publications

(21 citation statements)

References 20 publications

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“…This study highlights the need for head-to-head comparative studies estimating the relative efficacy of SCIT and SLIT in order to perform reliable comparative cost-effectiveness evaluations. We made rea- implemented, as shown, 61 to increase cost-effectiveness.…”

Section: Con Clus Ionsmentioning

confidence: 99%

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Cost‐effectiveness of grass pollen allergen immunotherapy in adults

Bona

Bilancia

Albanesi

et al. 2020

Allergy

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Background Major scientific societies, such as the EAACI or the AAAAI, do not express any suggestion on which form of allergen immunotherapy (AIT) is to be preferred (subcutaneous immunotherapy, SCIT, vs sublingual immunotherapy, SLIT). This choice could depend on their relative pharmacoeconomic value. Objective To assess the cost‐effectiveness of AIT for grass pollen, administered as SCIT or SLIT. Methods We created a Markovian Model, to evaluate, in a hypothetical cohort of adult patients suffering from moderate‐to‐severe rhino‐conjunctivitis with or without allergic asthma, the cost‐effectiveness of SLIT (tablets, Grazax® and Oralair®) or SCIT (various currently available products, plus indirect nonmedical costs, such as travel and productivity costs) in addition to pharmacological therapy, assuming a 9‐year horizon to capture AIT long‐term effects. The incremental cost‐effectiveness ratio (ICER) was calculated assuming pharmacological therapy as the reference comparator. Results In the base case, SCIT was slightly more expensive, but more effective than SLIT, being the most cost‐effective option (ICER for SCIT, €11 418; ICER for SLIT, €15 212). ICERs greater than €120 000 for both SCIT and SLIT were demonstrated in a scenario assuming that low treatment persistence rates, which are common in real‐life, lead to absence of long‐term AIT clinical benefit. Considering indirect nonmedical costs SLIT resulted more cost‐effective than SCIT (ICER for SCIT, €17 318; ICER for SLIT, €15 212). Conclusion In daily practice, AIT for grass pollens may be a cost‐effective option only in patients with low discontinuation rates. SCIT, which is less affected by this limitation than SLIT, seems the most cost‐effective AIT form.

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Section: Con Clus Ionsmentioning

confidence: 99%

“…Patients should be informed about how AIT works and the need for regularity in the administration schedule and completion of the course of treatment. Furthermore, strategies of systematic follow-up promoting adherence should be implemented, as shown, 61 to increase cost-effectiveness.…”

Section: Con Clus Ionsmentioning

confidence: 99%

Cost‐effectiveness of grass pollen allergen immunotherapy in adults

Bona

Bilancia

Albanesi

et al. 2020

Allergy

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“…± ARC that received mite and/or pollen conventional SCIT, female gender, asthma, Parietaria allergen content, and administration of two vaccines in each session have been found to increase the risk of LRs and SRs (30). In the study by Nacaroglu et al (31) from Turkey, SRs were found to be significantly higher in SCIT with multiple allergens in ARC patients accompanied by asthma, however, no statistically significant relation was found between adjuvant / allergen content and the frequency of side effects.…”

Section: Discussionmentioning

confidence: 99%

Standardized Quantitative Evaluation of Clinical Effectiveness and Side Effect Profile of Subcutaneous and Sublingual Allergen-Specific Immunotherapy in Children: A 5-Year Single Center Experience

Tökmeci¹,

Demirhan²,

SENGUL³

et al. 2021

Asthma Allergy Immunol

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Objective: Allergen-specific immunotherapy (allergen-SIT) is a treatment method with variable efficacy in allergic diseases. This study aimed to investigate the effectiveness of allergen immunotherapy, frequency of LRs and SRs and variables affecting these parameters in patients who underwent allergen-SIT. Materials and Methods: In this study, the recorded data of 81 patients, who received subcutaneous (SCIT) or sublingual (SLIT) allergen immunotherapy for respiratory allergic diseases between 2014 and 2019, were analyzed. In asthma and/or allergic rhinoconjunctivitis (ARC) patients, the effectiveness of treatment was evaluated by analysing the change rates in disease symptom, medication and combined scores (symptom + medication) and visual analog score (VAS). Treatment success was defined by the degree of decrease in scores as; high response above 50%; low response between 20-50%; and failure <20%.Results: The mean age of allergen-SIT initiation was 11.4± 3.1 years. Diagnostic distributions of the patients were asthma (± ARC) in 64.2%, and ARC (without asthma) in 35.8%. The mode of allergen-SIT was SCIT in 77.8% (65% asthma and 35% ARC) and SLIT in 22.2% (61.1% asthma and 38.9% ARC). The main allergens used in allergen-SIT were mite (79%), grass-grain pollen (33.3%), alternaria (9.9%) and olea (8.6%). There was a significant decrease in symptoms, medication, combined and VAS scores in the asthma and ARC groups (p <0.0001), when end-SCIT values were compared to baseline. SLIT also resulted in significant decreases in these scores except asthma medication score. Among the asthma patients the rate of high-responders was 88.8% by SCIT and 50% by SLIT, according to combined asthma score. Among the ARC (without asthma) patients the rate of high-responders was 100% for both SCIT and SLIT. SCIT resulted in local (LR) and systemic side effects (SR) in 18% and 0.6% (all Grade I and Grade II) of the total injections performed. A high number of total injections was significantly associated with higher LR and SR rates. While LR was observed in 16.6% of the patients who underwent SLIT, no systemic reaction was found in any of the patients. Conclusion: SCIT was highly successful in the treatment of asthma and ARC in terms of the degree of therapeutic response. SLIT resulted in a high rate of good response in ARC patients, but a lower response degree in asthmatic patients. Systemic side effects were very low as a result of close risk monitoring and the dose adjustments performed. Keywords: Allergen-specific immunotherapy, SCIT, SLIT, efficacy, symptom score, medication score, visual analog score, side effects

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“…Adapted from: Vrijens et al 10 they have also used various definitions for adherence, compliance and persistence (Table 1). [11][12][13][14][15][16][17][18][19][20][21][22] Of note, the terms adherence and compliance are used synonymously in the published literature. Therefore, in this publication, the term adherence is used throughout to encompass both adherence and compliance; persistence is referred to separately.…”

Section: G R a P H I C A L Abstractmentioning

confidence: 99%

Adherence and persistence in allergen immunotherapy (APAIT): A reporting checklist for retrospective studies

Pfaar

Devillier

Schmitt

et al. 2023

Allergy

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Background Adherence is essential for the long‐term efficacy of allergen immunotherapy (AIT) and has been evaluated in numerous retrospective studies. However, there are no published guidelines for best practice in measuring and reporting adherence or persistence to AIT, which has resulted in substantial heterogeneity among existing studies. The ‘adherence and persistence in AIT (APAIT)’ checklist has been developed to guide the reporting, design and interpretation of retrospective studies that evaluate adherence or persistence to AIT in clinical practice. Methods Five existing checklists, focussing on study protocol design, the use of retrospective databases/patient registries, and the appraisal and reporting of observational studies, were identified and merged. Relevant items were selected and tailored to be specific to AIT. The content of the checklist was discussed by 11 experts from Europe, the United States and Canada, representing allergy, healthcare and life sciences, and health technology appraisal. Results The APAIT checklist presents a set of items that should either be included or at least considered, when reporting retrospective studies that assess adherence or persistence to AIT. Items are organized into four categories comprising study objective, design and methods, data analysis, and results and discussion. The checklist highlights the need for clarity and transparency in reporting and emphasizes the importance of considering potential sources of bias in retrospective studies evaluating adherence or persistence to AIT. Conclusions The APAIT checklist provides a pragmatic guide for reporting retrospective adherence and persistence studies in AIT. Importantly, it identifies potential sources of bias and discusses how these influence outcomes.

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Safety and treatment compliance of subcutaneous immunotherapy: A 30-year retrospective study

Cited by 25 publications

References 20 publications

Cost‐effectiveness of grass pollen allergen immunotherapy in adults

Cost‐effectiveness of grass pollen allergen immunotherapy in adults

Standardized Quantitative Evaluation of Clinical Effectiveness and Side Effect Profile of Subcutaneous and Sublingual Allergen-Specific Immunotherapy in Children: A 5-Year Single Center Experience

Adherence and persistence in allergen immunotherapy (APAIT): A reporting checklist for retrospective studies

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