Grass Allergy Immunotherapy Tablet Research Articles

Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study.

IntroductionIntra-seasonal start of treatment with the SQ® grass sublingual immunotherapy (SLIT) tablet (GRAZAX®, ALK, Denmark) has been previously demonstrated to be well-tolerated. The objective of our study was to investigate the tolerability of intra-seasonal start of treatment comparing patients treated by allergists and general practitioners experienced in treatment of allergy (GPs).MethodsIn a non-interventional, open-label, observational study, data on intra-seasonal start with the SQ® grass SLIT tablet were recorded in patients treated by allergists and GPs in Germany. Adverse events (AEs) were recorded by the physicians at first administration and during the 1–3-month observation period. The tablets taken and any AEs were recorded by the patients in diaries for the first 14 days.ResultsTreatment with the SQ® grass SLIT tablet was started in 198 patients, and in 179 intra-seasonal (allergists: 140, GPs: 39) and 19 post-seasonal; average treatment period was 47 days. AEs related to intra-seasonal start were reported in 43.6% of patients; no relevant differences between allergists and GPs were observed. In the subgroup of GPs, patients were younger (p = 0.0191), had more frequently asthma (p = 0.0043), more patients used symptomatic medication in the previous pollen season (p = 0.0198) and were more frequently treated for other diseases (p = 0.0467). In the allergists subgroup, more diagnostic allergy tests were applied (p < 0.0001) with less anti-allergic premedication at first administration (p = 0.0026).ConclusionThe intra-seasonal start of treatment with the SQ® grass SLIT tablet in patients routinely treated by allergists or GPs with experience in treatment of allergy was well-tolerated, although patient characteristics were different with respect to age, frequency of asthma and concomitant allergies, use of symptomatic medication in the previous grass pollen season and concomitant treatment of other diseases. The safety profile from a previous placebo-controlled clinical trial and data from a previous real-life study on intra-seasonal start performed by allergists were confirmed.

Exploring The Burden of Illness and Impact of SQ-Standardised Grass Allergy Immunotherapy Tablet Treatment (AIT) on Quality of Life (QOL) in Patients with Allergic Rhinitis (AR) in Germany and The Netherlands

Exploring The Burden of Illness and Impact of SQ-Standardised Grass Allergy Immunotherapy Tablet Treatment (AIT) on Quality of Life (QOL) in Patients with Allergic Rhinitis (AR) in Germany and The Netherlands

Treatment Satisfaction During Routine Treatment with the SQ®-Standardised Grass Allergy Immunotherapy Tablet: A Non-interventional Observational Study

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

Health-Related Quality of Life During Routine Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet: A Non-Interventional Observational Study.

Background and ObjectiveAllergy 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.MethodsIn 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.ResultsOverall, 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 < 0.0001), and of RQLQ −1.31 ± 1.07 and +0.10 ± 0.74 (p < 0.001), and for HRQoL3 versus HRQoL2 (238 patients) of SF-12 −1.6 ± 15.3 and −10.0 ± 14.1 (p = 0.0003), and of RQLQ +0.22 ± 1.29 and +1.24 ± 1.30 (p < 0.0001). Tolerability and adherence for the SLIT-tablet were comparable with data of other non-interventional studies.ConclusionsRoutine treatment with the SQ® grass SLIT-tablet resulted in clear improvements in disease-specific and general quality of life, while no improvements were observed in patients treated only symptomatically.

Economic evaluation of SQ-standardized grass allergy immunotherapy tablet (Grazax(®)) in children.

BackgroundGrass pollen-induced rhinoconjunctivitis is a common allergic respiratory disorder affecting over 20% of the UK population in terms of quality of life and sleep, work, and school patterns. The SQ-standardized grass allergy immunotherapy tablet (AIT) has been demonstrated as a disease-modifying treatment which gives a sustained effect even after completion of a treatment course. The objective of this study was to provide an economic assessment of whether treatment with the SQ-standardized grass AIT, Grazax® (Phleum pratense) in combination with symptomatic medications is preferable to the standard of care using symptomatic medications only. The analysis was performed for children with grass pollen-induced rhinoconjunctivitis, with or without concomitant asthma, in the UK.MethodsThe model evaluated the two treatment regimens in a cohort of 1,000 children from a payer’s perspective. Treatment was modeled in terms of management of symptoms, impact on resource use, and development of allergic asthma. The analysis modeled the use of SQ-standardized grass AIT and the sustained effects of treatment over a 9-year time horizon (ie, 3 years of treatment, with modeled long-term benefits). Data inputs were drawn from a recent clinical trial, published studies, and databases.ResultsSQ-standardized grass AIT improves patient outcomes, generating an incremental cost per quality-adjusted life year gained of £12,168. This is below commonly accepted thresholds in the UK.ConclusionThe resulting incremental cost per QALY falls below commonly accepted willingness to pay thresholds. Therefore, the SQ-standardized grass AIT is a cost-effective option for the treatment of grass pollen-induced rhinoconjunctivitis in the UK pediatric population.

EQ-5D Health Utility Values In The Treatment Of Seasonal Grass Pollen Induced Rhinoconjunctivitis

Rationale: Standard clinical efficacy endpoints in allergen immunotherapy trials include the daily Rhinoconjunctivitis Symptom Score (RSS) and daily Rhinoconjunctivitis Medication Score (RMS). However, measurement of subjects' QoL in terms of health utility is also necessary to characterise changes in health status. In this study, we aimed to determine a relationship between standard efficacy endpoints and the health utility. Methods: Data from a 5-year DBPC phase III trial (GT-08, ALK, Denmark) in subjects with grass pollen induced rhinoconjunctivitis were analysed. During each pollen season, subjects recorded daily their RSS and RMS and weekly the EQ-5D index. A two-stage model was constructed: 1) binomial modelling of subjects with “perfect health” (EQ-5D utility=1) and 2) Gaussian modelling of EQ-5D utilities< 1. The utility during each grass pollen season was calculated as area under the curve. Results: A total of 16,690 weekly and 137,792 daily EQ-5D observations were recorded over the trial period. The binomial model showed the daily RSS and RMS to be the two most important predictors of “perfect health” (RSS: OR=0.729; p< 0.001; RMS: OR=0.841; p< 0.001). The Gaussian model of subjects with “imperfect health” confirmed this correlation. Based on relationship the average annual utility was estimated to 2.2 QALD. Conclusions: In a clinical trial including subjects with grass pollen induced rhinoconjunctivitis, the daily RSS and RMS were found to be suitable predictors of the EQ-5D health utility. The findings confirm the beneficial impact of the SQ-standardised Timothy grass allergy immunotherapy tablet (75,000 SQ-T/2,800 BAU, ALK) on health utilities with a clinical relevant QALY gain.

Safety and Tolerability of an Intra-seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet: A Non-interventional Observational Study Investigating the Feasibility During Routine Administration

Background and ObjectiveFor 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.MethodsIn 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.ResultsA 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.ConclusionThe 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.

A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma

BackgroundDesign and execution of immunotherapy trials for seasonal allergies may be complicated by numerous factors including variable allergy testing methods, pollen levels, and timing and intensity of other seasonal allergens. We evaluated grass allergy immunotherapy tablet (AIT) treatment in North American adults with grass pollen-induced allergic rhinitis with or without conjunctivitis (AR/C), with/without asthma.MethodsSubjects age 18–65 with clinical history of grass pollen–induced AR/C, with/without asthma were randomized 1:1 to once-daily 2800 BAU Timothy grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, containing approximately 15 μg of Phl p 5) or placebo. The AR/C symptom and medication scores were recorded daily. The primary end point was the average AR/C daily symptom score (DSS) during the entire grass pollen season (GPS). Ranked key secondary end points were Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, daily medication score (DMS), and percentage of well days, all over entire GPS. Safety was monitored through adverse event reporting.ResultsEfficacy analysis included 289 subjects. Over the entire GPS, mean DSS was 6% lower with AIT versus placebo (5.69 vs. 6.06), but this difference was not statistically significant (p = 0.3475) despite significantly higher immunological response in the grass AIT group. No significant between-group differences were seen for key secondary end points. In general, DSS was high before GPS began and no clear relationship between DSS and grass pollen counts was seen during GPS. In post hoc analysis of subjects with pre-seasonal DSS ≤3, mean DSS and DMS were both significantly lower with grass AIT versus placebo (27%; p = 0.0327 and 68%; p = 0.0060, respectively). In this subgroup a relationship between DSS and grass pollen counts was observed. Grass AIT was generally well tolerated, with no events of anaphylactic shock or respiratory compromise.ConclusionsIn this trial, 2800 BAU grass AIT did not demonstrate significant symptom improvement versus placebo. Lack of relationship between pollen count and symptom score in the study population, and post hoc findings among subjects with low pre-seasonal symptoms, suggest that the symptoms reported in this study were not primarily reflective of the effects of grass pollen exposure.Trial registrationNCT00421655

Grading local side effects of sublingual immunotherapy for respiratory allergy: Speaking the same language

Sublingual immunotherapy (SLIT) is increasingly used worldwide. Despite its safety being well ascertained, there is no universally accepted system to grade and classify its adverse events (AEs). According to the literature, it seems reasonable to classify and grade systemic side effects by using the previously published World Allergy Organization recommendations. On the other hand, local side effects are the most frequent with SLIT, sometimes leading to its discontinuation. Therefore grading of the severity of local side effects was perceived as necessary for the purpose of uniform reporting, classification, and quantification of this aspect. AWorld Allergy Organization Taskforce, after examining the available literature and the postmarketing surveillance data, proposed a clinically based grading of the severity of local AEs caused by SLIT. The use of the Medical Dictionary for Regulatory Activities nomenclature for AEs was also included in this context. The proposed grading system for SLIT-induced local reactions is expected to improve and harmonize surveillance and reporting of the safety of SLIT.

Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet is well Tolerated in Children, Adolescents and Adults in Real Life Application-A Non-Interventional Observational Study

Background: Efficacy and safety of the SQ-standardised grass allergy immunotherapy tablet (GRAZAX®) has been reported in a large number of randomised, controlled clinical trials in children and adults performed in Europe and the US. GRAZAX® became available for routine treatment in children from 5 years of age in Germany and Austria in 2008.To examine the safety and tolerability of GRAZAX® in patients that were less highly selected as in the controlled trials we performed an open label, uncontrolled, non-interventional study in children and adults who were routinely treated in allergists´ offices. Materials and methods: Patients with allergic rhinoconjunctivitis with or without asthma were treated with GRAZAX® and observed for 3-4 visits every 3 months with the last visit after the first grass pollen season. Adverse seasons before and during therapy. Results: Treatment was documented in 1,761 patients (797 75% in 89.8% of patients, >95% of patients and physicians were satisfied with treatment. Conclusion: The results of our study confirm the safety and tolerability profile observed in controlled clinical trials with GRAZAX®. Treatment satisfaction during routine application was rated high and was combined with a high compliance.

Efficacy and safety of the SQ‐standardized grass allergy immunotherapy tablet in mono‐ and polysensitized subjects

The efficacy of single-allergen-specific immunotherapy in polysensitized subjects is a matter of debate. We therefore performed a post hoc analysis of pooled data from six randomized, double-blind, placebo-controlled trials (N = 1871) comparing the efficacy and safety of the SQ-standardized grass allergy immunotherapy tablet (AIT), Grazax (Phleum pratense 75 000 SQ-T/2800 BAU, ALK, Denmark), in mono- and polysensitized subjects. A statistically significant reduction in the mean total combined symptom/medication score (TCS) of 27% was demonstrated in actively treated subjects compared with placebo (P < 0.0001). This was not dependent on sensitization status (P = 0.5772), suggesting a similar treatment effect in mono- and polysensitized subjects (i.e. reductions of the TCSs of 28% and 26%, respectively, both P < 0.0001). Finally, a comparable and favourable safety profile of grass AIT was demonstrated in the two subgroups. Thus, no difference in efficacy and safety of single-allergen grass AIT was observed between mono- and polysensitized subjects.

Budget impact analysis of two immunotherapy products for treatment of grass pollen-induced allergic rhinoconjunctivitis

BackgroundGrass pollen-induced allergic rhinoconjunctivitis constitutes a large burden for society. Up to 20% of European and United States (US) populations suffer from respiratory allergies, including grass pollen-induced allergic rhinoconjunctivitis. The majority of patients are treated with symptomatic medications; however, a large proportion remains uncontrolled despite use of such treatments. Specific immunotherapy is the only treatment documented to target the underlying cause of the disease, leading to a sustained effect after completion of treatment. The aim of this study was to compare the economic consequences of treating patients suffering from allergic rhinoconjunctivitis with either a grass allergy immunotherapy tablet (AIT) or subcutaneous immunotherapy (SCIT).MethodsA budget impact analysis was applied comparing SQ-standardized grass AIT (Grazax®; Phleum pratense, 75,000 SQ-T/2,800 BAU; ALK, Denmark) with SCIT (Alutard®; P. pratense, 100,000 SQ-U/mL; ALK, Denmark). Budget impact analysis included health care utilization measured in physical units based on systematic literature reviews, guidelines, and expert opinions, as well as valuation in unit costs based on drug tariffs, physician fees, and wage statistics. Budget impact analysis was conducted from a Danish health care perspective.ResultsTreating patients suffering from allergic rhinoconjunctivitis with grass AIT instead of grass SCIT resulted in a total reduction in treatment costs of €1291 per patient during a treatment course. This cost saving implies that approximately 40% more patients could be treated with grass AIT per year without influencing the cost of treatment.ConclusionBudget impact analysis showed that grass AIT is a cost-saving alternative to SCIT when treating patients with grass pollen-induced allergic rhinoconjunctivitis.

Safety and Tolerability of an SQ-Standardized GRAss ALlergy Immunotherapy Tablet (GRAZAX®) in a Real-Life Setting for Three Consecutive Seasons – The GRAAL Trial

GRAZAX(®) (Phleum Pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), an SQ-standardized grass allergy sublingual immunotherapy tablet for the desensitization of grass pollen-induced rhinoconjunctivitis, has been developed to facilitate patient access to specific immunotherapy (SIT), while minimizing the risk of serious treatment-related adverse events. As a minimum duration of 3 years is recommended for SIT treatment, the GRAAL trial aimed to assess the safety profile of GRAZAX(®) in real-world conditions during long-term treatment of patients with grass pollen-induced allergic rhinoconjunctivitis (ARC). A multicentre, prospective, open-label, observational trial was conducted over three consecutive grass pollen seasons from November 2007 to October 2010 in France. A total of 130 physicians included 628 patients with previously documented ARC. Patients received one tablet daily (no up-titration) for at least 4 months before the expected start of the pollen season (pre-season), which was then maintained throughout the entire season (co-season). The primary endpoint was safety and tolerability (immediate, i.e. each year at first tablet administration, and long-term) after pre- and co-seasonal exposure to GRAZAX(®). Patients were treated for an average of 5.5 months per year. After administration of the first tablet, immediate tolerable reactions (defined as benign, local, of short duration [<30 minutes] and not requiring any symptomatic treatment) were experienced by 54.6%, 38.4% and 33.6% of the patients during the first, second and third years of treatment, respectively. Immediate intolerable reactions (required study discontinuation, symptomatic medication or lasted >30 minutes) occurred in 14 patients (2.2%) during GRAZAX(®) initiation, and one patient (0.3%) at treatment reintroduction during the second year. Adverse events considered to be related to GRAZAX(®) were reported by 46.2%, 14.4% and 1.8% of patients, during the first, second and third years of treatment, respectively. The most frequently reported adverse events were mild-to-moderate local events (at the oral and pharyngeal mucosa levels). These symptoms mainly occurred within the first month of treatment initiation and subsequent tablet reintroduction. Daily administration of GRAZAX(®) for three consecutive years was generally safe and well tolerated. An improvement in the incidence of adverse events related to treatment was observed at reintroduction of GRAZAX(®) and during the course of treatment. http://clinicaltrials.gov (NCT01433510).

Treatment of seasonal allergic rhinoconjunctivitis with a once-daily SQ-standardized grass allergy immunotherapy tablet

Objectives:Specific immunotherapy with the grass allergy immunotherapy tablet (AIT) has been developed as an effective, well tolerated, and convenient treatment for grass pollen induced seasonal allergic rhinoconjunctivitis (ARC). Six phase II/III randomized, placebo-controlled trials with the duration of a single grass pollen season of treatment using the SQ-standardized grass AIT, Grazax (Phleum pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), have been published previously. This review compares results from these trials.Methods:As outcome measures and methods of assessing them were similar across the trials, we have summarized the main efficacy findings (Total Combined Score [TCS], average daily rhinoconjunctivitis symptom and medication scores, percentage of well days, quality of life scores) during a single season of treatment with grass AIT in adults and children with seasonal ARC.Results:The results of the European and North American trials were similar. Compared with the placebo group, who received symptomatic medications only, treatment with grass AIT resulted in fewer rhinoconjunctivitis symptoms, a lower intake of symptomatic medication, better patient self-rated quality of life and a greater percentage of well days during the entire grass pollen season. The data indicate that grass AIT treatment is equally effective in adults and children; the measured effect varies with pollen exposure, but is comparable across regions and continents, with a consistent difference compared with placebo in TCS that was above 20% for all trials. Local adverse events were experienced by the majority of patients. These reactions were generally mild to moderate in severity and transient in duration. Systemic adverse events were rare.Conclusions:This review confirms SQ-standardized grass AIT as a suitable therapeutic option for seasonal use in patients aged 5 years or older with grass pollen induced ARC.

4 The Risk of Severe Treatment Related Adverse Events is Significantly Lower in Children Compared to Adults When Treated With Standardized Timothy Grass Allergy Immunotherapy Tablets

BackgroundAllergy immunotherapy tablets (AIT) provides a safer and more convenient alternative to subcutaneous specific immunotherapy treatment. However, severe adverse events occur infrequently. These events are rare and therefore pooled safety data from 1 phase II/III and 6 phase III clinical trials (5 in adults, 2 in children (5–17 years)) with grass AIT (Grazax, Phleum pratense 75,000 SQ-T/2800 BAU, ALK, Denmark) were analysed.MethodAll trials were randomised, double-blind, placebo-controlled multi-centre trials. Subjects suffered from grass pollen induced allergic rhinoconjunctivitis with or without asthma, had positive skin prick test and specific IgE to Phleum pratense. Subjects received once-daily sublingual treatment with grass AIT or placebo for approximately 24 weeks. The 5 adult trials comprised 2095 treated subjects (AIT = 1060, placebo = 1035) and the 2 children trials comprised 597 treated subjects (AIT = 301, placebo = 296). Adverse events were assessed by the investigator as treatment-related (possible or probable) or unlikely related and for seriousness. Application site-related events were defined as adverse events in relation to the oral cavity.ResultsIn the adult trials, 71% of AIT-treated subjects reported treatment-related adverse events compared to 24% for placebo. In the children trials the corresponding numbers were 63% for AIT and 27% for placebo. Of the AIT-treated subjects 2 children (0.7%) and 32 adults (3.0%) experienced severe treatment-related events. The odds for severe events was 4.7 times lower in children compared to adults (odds-ratio with 95% CI, 0.22 [0.025-0.85], P = 0.019). Both AIT-treated children (0.7%) and 18 (1.7%) of the AIT-treated adults experienced severe treatment-related events that were application site-related. The odds for having severe related application site adverse events was 2.6 times lower in children compared to adults (odds-ratio with 95% CI, 0.39 [0.04-1.63], P = 0.27, not statistically significant). No serious treatment-related adverse events were reported.ConclusionThis pooled analysis of over 2000 subjects in 7 clinical trials shows that the risk of experiencing severe treatment-related adverse events was significantly lower in children compared to adults when treated with of Timothy grass allergy immunotherapy tablets. This analysis provides evidence that Timothy grass AIT is an important and safe immunotherapy treatment option in children with grass pollen induced rhinoconjunctivitis.

Timothy Grass Allergy Immunotherapy Tablets Reduce Nasal and Ocular Symptoms Associated With Allergic Rhinoconjunctivitis During Grass Pollen Season in North American Children and Adults: 2 Randomized, Placebo-Controlled Trials

The nasal and ocular symptoms of allergic rhinoconjunctivitis (ARC) are bothersome with a substantial negative impact on quality of life. The effect of Timothy grass allergy immunotherapy tablet (grass AIT) treatment on individual ARC symptoms was assessed in 2 randomized, double-blind trials in North American adults and children with grass pollen-induced ARC.

SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial

The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials. To investigate sustained efficacy and disease modification in a 5-year double-blind, placebo-controlled trial, including 2 years of blinded follow-up after completion of a 3-year period of treatment, with the SQ-standardized grass allergy immunotherapy tablet, Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU,(∗) ALK, Denmark) orplacebo. A randomized, double-blind, placebo-controlled, multinational, phase III trial included adults with a history of moderate-to-severe grass pollen-induced allergic rhinoconjunctivitis, with or without asthma, inadequately controlled by symptomatic medications. Two hundred thirty-eight participants completed the trial. End points included rhinoconjunctivitis symptom and medication scores, combined scores, asthma symptom and medication scores, quality of life, days with severe symptoms, immunologic end points, and safety parameters. The mean rhinoconjunctivitis daily symptom score was reduced by 25% to 36% (P ≤ .004) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial. The rhinoconjunctivitis DMS was reduced by 20% to 45% (P ≤ .022 for seasons 1-4; P= .114 for season 5), and the weighted rhinoconjunctivitis combined score was reduced by 27% to 41% (P ≤ .003) in favor of active treatment. The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group, with relative differences of 49% to 63% (P ≤ .0001). Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response. No safety issues were identified. The results confirm disease modification by SQ-standardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis.

Efficacy of Timothy grass allergy immunotherapy tablet (AIT) treatment in Canadian children and adults with grass pollen-induced allergic rhinoconjunctivitis (ARC)

Methods Subjects 5 years and older with ARC with/without asthma received once-daily 2800 BAU sublingual grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, ~15μg Phl p5) or placebo starting approximately 16 weeks before and continuing throughout the 2009 grass pollen season (GPS). Subjects used daily e-diaries to record ARC symptoms and use of symptomatic medications from randomization through study end (approximately 24 weeks). The primary efficacy endpoint comprised the average total combined daily symptom and medication score (TCS) during the entire GPS. Secondary endpoints included average daily symptom score (DSS) and average daily medication score (DMS). Safety was assessed by monitoring adverse events (AEs).

A Multicenter, Randomized, Parallel-Group Trial Assessing Compliance, Tolerability, Safety, and Efficacy to Treatment with Grass Allergy Tablets in 261 Patients with Grass Pollen Rhinoconjunctivitis

Background. Allergen-specific sublingual immunotherapy (SLIT) is considered a causal treatment of respiratory allergies. Compliance to the SLIT is an important aspect for a positive clinical outcome. Study Aim. To evaluate if compliance with grass Allergy Immunotherapy Tablet (AIT) can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm). Patients and Methods. 261 patients with grass allergy were enrolled and randomized (1 : 1) to 1-year treatment with AIT (Grazax) using a CED (group A; n = 122) or without (Group B, n = 139). Compliance was measured through tablet count at each visit. Results. The 12-month compliance, mean (SD), in group A was 83% (21) and 83% (24) in group B. A total of 81% of patients reported a significant clinical improvement of symptoms after treatment in comparison with the previous year. No severe adverse reactions were observed in the study. Conclusion. Compliance to the treatment with AIT administered for 12 consecutive months is in general good. The use of CED is not associated with a greater compliance. AIT treatment was associated with a significant clinical improvement in >80% of patients with a good tolerability and safety profile.

Efficacy and Safety of Timothy Grass Allergy Immunotherapy Tablets in North American Children and Adolescents

M Blaiss, J Maloney, H Nolte, S Gawchik, R Yao, SP Skoner. J Allergy Clin Immunol. 2011;127(1):64–71, 71.e1–71.e4 To investigate the efficacy and safety of timothy grass allergen immunotherapy (AIT) treatment using sublingual tablets in children and adolescents with grass pollen–induced allergic rhinoconjunctivitis (ARC). Three hundred forty-five subjects, aged 5 to 17 years, with a clinical history of physician-diagnosed grass pollen–induced ARC with or without asthma were studied. This was a double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase III study. Subjects were randomly assigned (1:1) to once-daily sublingual grass AIT treatment (2800 bioequivalent allergen units; 15 μg of Phlp5) or placebo. Treatment began ∼16 weeks before …