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Background and Objective Allergy immunotherapy (AIT) with the SQ® grass sublingual immunotherapy (SLIT)-tablet has been shown to be efficacious, well-tolerated and to improve disease-specific health-related quality of life (HRQoL) in controlled clinical trials. The aim of our study was to investigate HRQoL in patients with allergic rhinoconjunctivitis routinely treated with the SLIT-tablet and taking symptomatic medication as needed compared with patients treated only with symptomatic medication. Methods In a non-interventional, open-label study, patients treated with the SLIT-tablet were observed for about 12 months compared with patients only symptomatically treated. Patients assessed their HRQoL with the 12-Item Short Form Health Survey (SF-12) and the Rhinitis Quality of Life Questionnaire (RQLQ) in the grass pollen seasons (GPS) at baseline (GPS1, HRQoL1), after GPS1 (HRQoL2) and in the following GPS (GPS2, HRQoL3). Tolerability, compliance, symptoms and medication use were assessed in the SLIT-tablet group by the physician. Results Overall, data were analysed in 576 patients. Mean differences (±SD) in overall scores for HRQoL3 versus HRQoL1 (186 patients) of SF-12 were +11.4 ± 16.8 (SLIT-tablet) and −3.4 ± 15.7 (symptomatic medication), (p

Background and Objective For specific immunotherapy to pollen allergy, a pre-seasonal start of treatment is recommended by international guidelines. In a placebo-controlled clinical trial with adults, an intra-seasonal start of therapy with the SQ-standardised grass allergy immunotherapy tablet (AIT) was well-tolerated. The objective of our study was to investigate the feasibility of an intra-seasonal start of grass AIT administered during routine treatment by practising allergists. Methods In a multicentre, prospective, open-label, uncontrolled, non-interventional observational study, data on routine treatment with grass AIT were recorded in patients who started administration of tablets within the 2010 grass pollen season in Germany. Adverse events (AEs) were recorded by the physician at visits for the first administration in the clinic and at the end of the 1- to 3-month observation period. AEs and daily administration of the tablet were recorded by the patients in diaries for the first 14 days. Treatment satisfaction, global tolerability and perceived effect of treatment were assessed by the patient and physician at the end of the study. Results A total of 662 patients were treated with 1 tablet daily by 286 physicians. Grass AIT was started intra-seasonally in 620 patients and post-season in 42. The average treatment period was 51.6 days. AEs were recorded in 52.1 % of all patients and in 35.6 % at first administration, with throat irritation (21.3 %), paraesthesia oral (19.9 %), oral pruritus (14.0 %) and ear pruritus (10.3 %) being the most frequent AEs related to grass AIT. The intensity of the AEs was assessed as mild or moderate in 42.1 % of patients and severe in 8.0 %; AEs related to grass AIT were classified as serious in two patients. Grass AIT was discontinued due to AEs in 7.7 % of patients. Diaries were evaluable for 77.0 % of patients; the average rate of patients with AEs decreased continuously from 44.7 % (day 1) to 26.9 % (day 14) and the average daily rate of patients who forgot to take their tablet was about 5 %. Overall tolerability was assessed by 87.2 % of patients and 91.4 % physicians as “very good” or “good” and effectiveness of treatment was assessed as “very good” or “good” in 81.4 % of patients and 85.8 % of physicians. More than 90 % of patients and physicians were satisfied with the treatment. Conclusion The tolerability data for an intra-seasonal start of grass AIT during routine treatment confirm the safety profile from the previous controlled trial. Tolerability was assessed as good in combination with high satisfaction with the treatment and compliance.

Therapy with the SQ®-standardised grass sublingual immunotherapy (SLIT)-tablet has been shown to be efficacious and well-tolerated in a large clinical development programme. The objective of this study was to investigate patients’ satisfaction with treatment by the SQ® grass SLIT-tablet during routine application. In the setting of a non-interventional, open-label, observational study, patients with allergic rhinoconjunctivitis were started on the SQ® grass SLIT-tablet 4–5 months before the grass pollen season and were followed until the end of the season. Treatment satisfaction was assessed by patients completing the Treatment Satisfaction Questionnaire for Medication (TSQM II, German version 1.4) before and after the grass pollen season. Compliance and changes in subjective well-being were also assessed. Data of 271 patients treated with the SQ® grass SLIT-tablet by 117 allergists in Germany were analysed. The TSQM score for global satisfaction was (mean ± standard deviation) 79.40 ± 19.98 after 6–9 months of therapy, with the highest scores for the dimensions side effects (92.89 ± 16.49) and convenience (88.19 ± 14.33), followed by effectiveness (70.74 ± 25.20). Treatment effect was assessed by the treating physician as very good or good in 83.1% of patients. The subjective well-being of the patients compared with the previous years was assessed as improved by 87.8% of the patients at the end of the study. Global satisfaction measured with the TSQM in patients treated with the SQ® grass SLIT-tablet was high, with the highest scores in the dimensions side effects and convenience, followed by effectiveness, and increased between 3 months and 6–9 months of treatment initiation. ALK-Abello Arzneimittel GmbH

Background The majority of allergic patients are poly-sensitized. For causal treatment by allergy immunotherapy (AIT) a single or few allergen products containing the clinically most relevant allergens are applied, but few data on tolerability of multiple application of AIT is available. The aim of our study was to investigate safety and tolerability in patients who started treatment by sublingual immunotherapy (SLIT) with the standardised SQ® grass SLIT-tablet and were treated with concomitant AIT products. Methods In a non-interventional, open-label, observational study in Germany treatment of patients with the SQ® grass SLIT-tablet and concomitant AIT (SCIT or SLIT) was documented between January 2012 and January 2014. Patients were followed at visits at first administration of the SQ® grass SLIT-tablet and after 1–3 months of treatment. Tolerability of the treatment with the SQ® grass SLIT-tablet and concomitant AIT were assessed by the physician and administration of AIT and adverse events (AEs) were recorded by the patients in diaries. AEs and adverse drug reactions (ADRs) were coded by using the Medical Dictionary for Regulatory Activities. Results In total, 181 patients were documented by 48 allergists and 160 patients treated with a concomitant AIT (SCIT 130, SLIT 30). AEs were reported in 58 (36.3 %) patients with concomitant AIT, and AEs considered related with the SQ® grass SLIT-tablet in 49 (30.6 %) and with concomitant AIT in 18 (11.3 %) patients. Treatment was discontinued due to ADRs in 12 (7.5 %) patients and severity of ADRs was assessed mild or moderate in 29 (18.1 %), and severe in 20 (12.5 %) patients. Most common reactions were localised at the application site of the SQ® grass SLIT-tablet as oral pruritus, throat irritation, oedema mouth and paraesthesia oral; no serious ADRs were reported. Overall tolerability of the SQ® grass SLIT-tablet if given with concomitant AIT was assessed as “good” or “very good” by 91.0 % of patients and 91.6 % of physicians. Conclusions In comparison to data from previous studies no increase in frequency of AEs or change in the tolerability profile was observed when SLIT with the SQ® grass SLIT-tablet was administered with concomitant SCIT or SLIT.