Patient Needs and Benefits of Sublingual Immunotherapy for Grass Pollen-Induced Allergic Rhinitis: An Observational Study

Klein, Toni Maria; Hadler, Meike; Augustin, Matthias; Blome, Christine

doi:10.2217/imt-2021-0161

Cited by 6 publications

(19 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“… Italian prospective, open-label, observational study over 1 season Pastorello et al 58 Children and adults (12–45 y) with mild/moderate-severe ARC ± mild asthma (n=47) Reduction in symptom severity and medication use. German 1-y prospective, open-label, observational study Klein et al 59 Children and adults (≥5 y) with moderate-severe ARC ± mild asthma (n=883) 90% of subjects (children, adolescents and adults) reported benefit (as measured using the ‘Patient Benefit Index—Allergic Rhinitis (PBI-AR) score’. Benefits were similar in mono- and polyallergic children but higher in polyallergic adolescents and adults.…”

Section: Efficacy and Safety Of Oralair® In Allergic Rhinitismentioning

confidence: 99%

“…Clinically relevant benefit was reported in 89–95% of subjects in all age-groups; in adolescents and adults, higher benefit was reported in polyallergic subjects than in monoallergic subjects. 59 Some data indicate benefit in patients sensitized to both temperate and subtropical grasses. A small observational study evaluated the impact of Oralair® over three consecutive pollen seasons in Australian patients (n = 63); of which 93.2% had ryegrass pollen allergy.…”

Section: Efficacy and Safety Of Oralair® In Allergic Rhinitismentioning

confidence: 99%

See 1 more Smart Citation

Update about Oralair® as a treatment for grass pollen allergic rhinitis

Klimek

Mösges

Demoly

et al. 2022

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Sublingual immunotherapy (SLIT) is a well-tolerated, safe, and effective approach to treating allergic rhinitis (AR). Oralair® is a five-grass pollen SLIT tablet containing natural pollen allergens from five of the major grass species responsible for seasonal AR due to grass pollen allergy. Recommended use is in a pre-coseasonal regimen, starting daily treatment approximately 4 months before the start of the pollen season, with treatment then continued daily throughout the season; treatment should continue for 3–5 y. Clinical efficacy and safety of Oralair® in patients with grass pollen-induced AR has been demonstrated in a comprehensive clinical development program of randomized controlled trials. Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging.

show abstract

Section: Efficacy and Safety Of Oralair® In Allergic Rhinitismentioning

confidence: 99%

Section: Efficacy and Safety Of Oralair® In Allergic Rhinitismentioning

confidence: 99%

Update about Oralair® as a treatment for grass pollen allergic rhinitis

Klimek

Mösges

Demoly

et al. 2022

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

show abstract

“…The items with the highest mean importance ratings were ‘to be able to do anything you want in your free time even while having hay fever’ (mean = 3.5) in children and ‘no longer have hay fever symptoms’ (mean = 3.3) in adolescents (Table 2 ; see also Klein et al [ 24 ] for a detailed discussion of the results). The item with the lowest importance rating as measured with the PNQ was ‘not be excluded by others’ with a mean score of 1.9 in children and 1.4 in adolescents.…”

Section: Resultsmentioning

confidence: 99%

“…The items with the highest patient-reported treatment benefit as measured with the PBQ (Table 3 ) were ‘need less time for treatment’ (children: 3.3, adolescents: 3.1) and ‘have an easily applicable treatment’ (children: 3.3, adolescents: 3.0). The lowest mean values were found for ‘no longer have a runny or stuffy up nose’ (children: 2.2, adolescents: 2.3), and ‘no longer have to sneeze’ (children and adolescents: 2.2; see also Klein et al [ 24 ] for a detailed discussion of the results). Benefit ratings showed similar patterns by sex and by the prevalence of asthma with somewhat higher benefits for male patients and those with asthma (Fig.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Development and validation of a tool for the assessment of benefit from treatment of allergic rhinitis in children and adolescents (PBI-AR-K)

Klein

Eisner

Augustin

et al. 2022

Allergy Asthma Clin Immunol

View full text Add to dashboard Cite

Background Allergic rhinitis (AR) is frequent in children and adolescents and can severely affect their lives. This article describes the development and validation of a questionnaire to assess treatment needs and benefits in children and adolescents, the PBI-AR-K, in a sample of patients receiving grass pollen sublingual immunotherapy. Patients and methods The PBI-AR-K was developed based on an open survey including children and adolescents and expert consensus between methodologists, patients, and physicians. The PBI-AR-K assesses patient needs before the treatment and perceived benefit during or at the end of a treatment. A weighted benefit score can be calculated ranging from 0 to 4 (4 = highest possible benefit). The validation was conducted in children (5–12 years) and adolescents (13–17 years) receiving sublingual immunotherapy. Subscales were developed based on factor analysis. Psychometric properties of items and scales were assessed with descriptive statistics, internal consistency, and convergent validity. Results The final PBI-AR-K consists of 19 items. For validation, data from 345 patients (mean age 11.1; 60.9% male; n = 223 children; n = 122 adolescents) was analysed. Factor analyses resulted in four subscales for children and three subscales for adolescents. The items with the highest importance ratings were about choice of leisure activities (mean value in children: 3.5) and about being free of AR symptoms (adolescents: 3.3). The weighted PBI-AR-K scores reflected considerable patient-reported benefit (2.08–2.82) in both children and adolescents. Internal consistency of all scales was good or acceptable. In the children’s sample, the global scale and three of four subscales were quite consistently correlated with convergent variables, while the subscale ‘treatment burden’ was significantly correlated only with change in average impairments due to rhinitis symptoms. The adolescents’ sample showed more inconsistent results with only change in rhinitis severity being significantly associate with all subscales. Conclusion The newly developed PBI-AR-K is a reliable and valid questionnaire for use in children; for the use in adolescents, it should be further elaborated.

show abstract

Clinical relevance of pre‐ and coseasonal sublingual immunotherapy with a 300 index of reactivity 5‐grass SLIT tablet in allergic rhinoconjunctivitis

Pfaar,

Wahn,

Canonica

et al. 2023

Clinical & Translational All

View full text Add to dashboard Cite

BackgroundThere is considerable interest in improving the scoring methods for evaluating the efficacy of allergen immunotherapy (AIT) and to show if this is associated with clinically meaningful results from the patient's perspective. We aimed to assess the efficacy and clinical relevance of a 300 index of reactivity (IR) 5‐grass pollen sublingual immunotherapy (SLIT) tablet in children, adolescents and adults with moderate to severe grass‐induced allergic rhinoconjunctivitis (ARC) with or without controlled asthma using the combined symptom and medication score CSMS0‐36.MethodsThe data of the European population that participated in 3 Phase III, international, randomized double‐blind placebo‐controlled clinical trials were analyzed post hoc.ResultsA total of 864 patients randomized to 300 IR 5‐grass tablet or placebo were analyzed. Over the primary evaluation period, the difference in CSMS0‐36 between the 300 IR and placebo groups was statistically significant (point estimates: −2.51, CI95% [−3.88; −1.14], p < 0.0001 in clinical trial1; −2.31, CI95% [−3.39; −1.23], p < 0.0001 in CT2; and −2.31, CI95% [−3.58; −1.03], p = 0.0004 in CT3). The relative differences between the 300 IR 5‐grass tablet and placebo were −29.7%, −33.8%, and −26.3%, respectively. The results based on CSMS0‐36 were consistent with those obtained with the primary endpoints of the trials and support the consideration of the 2‐point threshold of the CSMS0‐36 for clinical relevance of AIT.ConclusionPost hoc analysis of 3 CTs with the 300 IR 5‐grass SLIT tablet confirmed its significant and clinically relevant effect in the European population with grass pollen‐induced ARC with or without controlled asthma.

show abstract

Patient Needs and Benefits of Sublingual Immunotherapy for Grass Pollen-Induced Allergic Rhinitis: An Observational Study

Cited by 6 publications

References 29 publications

Update about Oralair® as a treatment for grass pollen allergic rhinitis

Update about Oralair® as a treatment for grass pollen allergic rhinitis

Development and validation of a tool for the assessment of benefit from treatment of allergic rhinitis in children and adolescents (PBI-AR-K)

Clinical relevance of pre‐ and coseasonal sublingual immunotherapy with a 300 index of reactivity 5‐grass SLIT tablet in allergic rhinoconjunctivitis

Contact Info

Product

Resources

About