In clinical practice, pre- and coseasonal treatment with a 5-grass pollen sublingual tablet is safe and well tolerated in children and adolescents.

After 1 year of treatment, polyallergic patients responded similarly to the five-grass pollen tablet as monoallergic patients. For polyallergic patients in whom additional treatment was needed, a second SLIT may be more beneficial than a SCIT or symptomatic co-medication.

BackgroundSublingual immunotherapy (SLIT) is a safe/well-tolerated alternative to allergen injection immunotherapy for allergic rhinoconjunctivitis (ARC). Patient adherence is essential and patient-related outcome measures including treatment satisfaction are informative/indicative of adherence.ObjectiveThe aim was to assess treatment satisfaction with five-grass pollen tablet SLIT under real-life conditions.MethodsTreatment satisfaction among adults taking SLIT with a five-grass pollen tablet for grass pollen-related ARC was assessed with QUARTIS, a self-report questionnaire dedicated to the management of patients treated with SLIT for ARC. This 1-year prospective, non-interventional, post-authorization study was conducted in Germany between 2008 and 2010.ResultsOf the 327 patients treated with the five-grass pollen tablet, 253 completed the QUARTIS questionnaire before and during (at least one item) treatment and were included in this analysis. Between the baseline and the treatment season, significant improvements were documented in nasal and ocular symptoms, and in the impact of allergy on everyday life. At the end of the first treatment period, patients had an improved opinion of the ease of SLIT intake and a significantly improved perception of SLIT. Compliance, overall satisfaction and motivation to continue SLIT the following year were good. Physicians’ assessments showed reduced symptoms and a reduced need for symptomatic medication throughout the study. SLIT was also well tolerated.ConclusionUnder real-life conditions, five-grass pollen tablet treatment was associated with a good level of treatment satisfaction, good symptom control, a reduced need for symptomatic medication, and favourable tolerability. These facets impacted favourably on patient functioning, disposition towards this medication, and adherence.

Aim: Clinical efficacy of sublingual immunotherapy for grass pollen-induced allergic rhinitis (AR) needs to translate into patient benefit. Patients & methods: Patients received Oralair (Stallergenes, Antony, France) in real-life medical practice. Patient-relevant treatment benefits were measured with the AR-specific Patient Benefit Index. Subgroups were analyzed regarding distinct patient characteristics. Results: Data of 883 patients (children, adolescents, and adults) were analyzed. The highest-ranked patient needs referred to having less AR-symptoms, being able to go outdoors, and being free in the choice of leisure activities. Most patients (89.2–94.6%) attained at least minimally relevant benefit. All subgroups reported relevant benefits, with significantly higher scores in some subgroups. Conclusion: Treatment with Oralair was associated with considerable patient-relevant benefit in all age groups.

IntroductionAllergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e. patients with different clinical profiles in daily clinical practice.MethodsIn a 2-year, prospective, open-label, multicenter, non-controlled, observational study patients were included from 327 centers across Germany. Rhinoconjunctivitis symptoms, symptomatic medication intake and adverse events were recorded.ResultsA total of 1482 patients aged 4–75 years were included. During the 2-year period of 5-grass pollen tablet therapy, mean rhinoconjunctivitis score decreased significantly in the overall study population by 65.5% (P < 0.001). The percentage of patients taking symptomatic medication decreased from 83.8% to 42.7%. Mean 2-year improvements in rhinoconjunctivitis scores and decreases in the percentage of patients taking symptomatic medication were broadly similar in adults, adolescents and children, in patients with polyallergy versus monoallergy, and in patients with/without asthma. Among polyallergic patients, concomitant application of another specific immunotherapy did not impair treatment outcomes. Adverse drug reactions, predominantly affecting the local application area, occurred in 15.4% of the overall patient population (n = 229). No cases of anaphylaxis or epinephrine use were documented.ConclusionThis study indicates that sublingual immunotherapy with the 5-grass pollen tablet is well tolerated and provides sustained effectiveness over 2 years in patients with different clinical profiles, producing a significant decrease in allergic symptoms and a reduction in the use of symptomatic medication.FundingStallergenes GmbH.

Introduction: Sublingual immunotherapy (SLIT) with birch pollen extract has been shown to be an efficacious treatment of allergic rhinitis (AR). An as-yet unanswered question is whether and how clinical benefit translates into patient benefit, i.e. what benefit patients derive from this treatment. Methods: This 1-year, open, prospective, multicenter, non-interventional study conducted in 75 German centers measured patient-relevant benefit of birch pollen SLIT (Staloral Ò Birch) using the questionnaire ''Patient Benefit Index for Allergic Rhinitis (PBI-AR)''. At treatment onset, patients rated the importance of 25 treatment needs; after the first birch pollen season on treatment, goal achievement was evaluated. A preference-weighted benefit index was calculated and its association with gender, asthma, allergy status, and severity of AR symptoms was determined. Results: Mean age of the 291 adult patients was 38.8 years; 58.4% were female. The most important treatment goals were to ''be able to stay outdoors without symptoms'' (87.3% quite or very important), ''no longer have a runny or stuffed-up nose'' (86.9%), and ''be able to breathe through your nose more freely'' (86.9%). The treatment goals with the highest benefit ratings (referring to those patients to whom the respective goal applied) were to ''have confidence in the therapy'' (60.5% has helped ''quite'' or ''very much''), ''have an easily applicable treatment'' (55.6%), and ''be able to breathe through my nose more freely'' (51.7%). The average PBI-AR global score was 2.19 (SD 1.04) (0-4; with 4 indicating maximum benefit). No significant differences in PBI-AR global score or subscales were found between men and women, poly-and monoallergic patients, or patients with severe versus mild rhinoconjunctivitis. Patients with asthma reported relevant but lower benefit than patients without asthma. Conclusion: After 1 year of birch pollen SLIT treatment, patients reported considerable benefit, mainly due to a reduction of physical symptoms and treatment burden.

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Background. Although the safety and efficacy of sublingual immunotherapy (SLIT) with a five-grass pollen tablet have been demonstrated in randomized clinical trials (RCTs), these outcomes must always be evaluated in real-life medical practice. Methods. In a prospective, open-label, noninterventional, “real-life” study in Germany, we evaluated the safety, tolerability, and effectiveness of SLIT with a five-grass pollen tablet in adults with grass-pollen-induced allergic rhinoconjunctivitis. Results. 808 adults were enrolled between September 2008 and December 2009. 35.3% of the participants experienced at least one adverse drug reaction (ADR), the most common of which were mild-to-moderate gastrointestinal and respiratory disorders. Serious ADRs considered causally related to SLIT treatment occurred in four patients. Overall, the five-grass pollen tablet was considered to have good or very good tolerability by most investigators and patients. Treatment was associated with the relief of nasal, ocular, and bronchial symptoms and decreased symptomatic medication use. However, interpretation of clinical improvements was limited by lower atmospheric grass pollen levels during the study season (relative to the preceding season). Conclusions. In a large population of patients treated in real-life medical practice, SLIT with a five-grass pollen tablet was safe and well tolerated. The patient-reported symptom relief suggests that SLIT was associated with clinical benefits.