Quantitative assessment of the compliance with once‐daily sublingual immunotherapy in children (EASY Project: Evaluation of A novel SLIT formulation during a Year)

Abstract

Compliance is a major determinant for allergy treatment, especially in children. Sublingual immunotherapy (SLIT) is self-managed at home, and no quantitative data on pediatric adherence are available. We studied the compliance in a large real-life setting. A simplified schedule of SLIT was used, consisting of a 10-day updosing phase followed by maintenance treatment in monodose containers to be taken daily (SLITOne). Italian specialists throughout Italy assessed the compliance in children who were newly prescribed SLIT according to guidelines. Parents were contacted with unscheduled telephone interviews at the third and sixth month of therapy and asked to count at that moment the remaining vials. Data from 71 children (38 boys, age range 2-13 yr) were enclosed in the database. Thirty had rhinoconjunctivitis, four asthma and 37 rhinoconjunctivitis + asthma. SLIT was prescribed for: mites in 57 (81%) subjects, grasses in 11 (15%) and 3 (4%) grass + olive mixture. Compliance data were available for all children at 3 months, and for 56 at 6 months. At 3 months, 85% of subjects had a compliance rate >75% (69% of them adhered >90%). At 6 months, 84% had a compliance rate >75% (66% of them adhered >90%). In four cases SLIT was discontinued for economical reasons, and in one case (1.4%) for side effects probably related to therapy. These data obtained in a quite large sample of children and in real-life confirm that the compliance with SLITOne is good, despite the therapy managed at home.

Comprehensive Study of Patients’ Compliance with Sublingual Immunotherapy in House Dust Mite Perennial Allergic Rhinitis

“…data are in agreement with several previously published studies of patients with PAR, which have reported the rates of around 70-80%[10,15,[17][18][19][20][21][22]. Another study has reported a higher compliance of approximately 97%[20].However, in that study, the patients counted the pills themselves and reported via a Variations caused by the method of compliance measurement were apparent in our study.…”

“…The available data on the patient adherence to allergen-specific immunotherapy are often conflicting [11,12]. In particular, in allergic rhinitis, compliance rates for sublingual administration range between 70% and 97% [10,[13][14][15][16][17][18][19][20][21][22]. This wide variation might be explained by differences in the characteristics and methodology of the studies, such as the population profiles and the definition of compliance [23].…”

Allergen Immunotherapy Adherence in the Real World: How Bad Is It and How Can It Be Improved?

“…Costs are a common drawback for both AIT routes of administration [29,31,34,39,45,46,49,62]. An Italian study shows that costs are responsible for SLIT discontinuation over time.…”

Specific Immunotherapy in Children: The Evidence

“…Concerning specific compliance and adherence studies, the available data indicate quite satisfactory results (74) The approach of evaluating the adherence by measuring the consume of allergen extracts was used in other 3 studies, which were facilitated by the fact that preparations in tablets or in liquid monodoses were employed (75,76,77). In the first ofthese the adherence value comprised between 75% and 97%, in the second 76.3% of the patients after 3 months and 74.8% of the patients after 6 months had compliance higher than 90%, in the third study on children a compliance rate higher than 75% was found in 85% of the children at the third month and in 84% of the children at the sixth month and the major cause of withdrawal (5.6% of the cases) was the cost of the treatment, while side effects accounted for 1.4% of stopping.…”