The Experts below are selected from a list of 1638 Experts worldwide ranked by ideXlab platform
Albrecht Bufe - One of the best experts on this subject based on the ideXlab platform.
-
Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy
The Journal of Allergy and Clinical Immunology, 2009Co-Authors: Albrecht Bufe, Roland Knecht, Bente Tholstrup, Peter Eberle, Eivy Franke-beckmann, Jürgen Funck, Martin Kimmig, Ludger Klimek, V. Stephan, Christian WeißhaarAbstract:Background Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended. Objective To investigate the efficacy of treatment with the grass tablet on grass pollen–induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children. Methods A total of 253 children age 5 to 16 years, with grass pollen–induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores. Results The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was Oral Pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related. Conclusion Immunotherapy with the grass tablet reduced grass pollen–induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.
-
Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children
Pediatric Allergy and Immunology, 2007Co-Authors: María Dolores Ibáñez, Friedrich Kaiser, Roland Knecht, Alicia Armentia, Helmut Schöpfer, Bente Tholstrup, Albrecht BufeAbstract:The aim of the study was to confirm the safety of an orodispersible grass allergen tablet 75,000 SQ-T (Grazax®, ALK-Abello A/S, Horsholm, Denmark) in children aged 5-12 yr. The study was randomized, double-blinded and placebo-controlled. Sixty children aged 5-12 yr suffering from grass pollen-induced rhinoconjunctivitis (with or without asthma) from five centres in two countries (three in Germany and two in Spain) participated in the study. They were randomized at the ratio of 3:1 as receiving either Grazax or placebo tablet given sublingually once daily for 28 days outside the grass pollen season. A total of 810 treatment-related adverse events were reported in the Grazax group. The majority of these were local reactions in the mouth or throat and were mostly mild (71%) to moderate (27%) in severity and resolved within days. Thirty-five (78%) subjects treated with Grazax and five (33%) treated with placebo reported at least one treatment-related adverse event. Oral Pruritus, throat irritation, mouth oedema and ear Pruritus appeared as the most frequently reported treatment-related adverse events. 62% (28 of 45) of the actively treated subjects reported Oral Pruritus, 36% (16 of 45) throat irritation, 31% (14 of 45) mouth oedema and 22% (10 of 45) ear Pruritus. Two actively treated subjects withdrew from the study: one subject due to four adverse events (moderate eye Pruritus, moderate pharyngolaryngeal pain, moderate non-cardiac chest pain and moderate dysphagia) and one subject due to a serious adverse event (asthmatic attack). The subjects recovered completely from the events. In conclusion, in the present study, Grazax was in general tolerated in a paediatric population and considered suitable for further clinical investigations in children.
Hendrik Nolte - One of the best experts on this subject based on the ideXlab platform.
-
Safety of Timothy Grass Sublingual Immunotherapy Tablet in Children: Pooled Analyses of Clinical Trials.
The journal of allergy and clinical immunology. In practice, 2020Co-Authors: Susanne Halken, Hendrik Nolte, Graham Roberts, Erkka Valovirta, Veronica Hulstrøm, Michael S. BlaissAbstract:Background Timothy grass sublingual immunotherapy (SLIT) tablets are indicated for children with allergic rhinitis with or without conjunctivitis. Objective To use pooled analyses to assess the short- and long-term tolerability and safety of timothy grass SLIT-tablet in children. Methods Data from 9 double-blinded, randomized European or North American trials that included children with allergic rhinitis with or without conjunctivitis treated up to 3 years with once-daily timothy grass SLIT-tablet or placebo were pooled. Results In all, 1818 (timothy grass SLIT-tablet, n = 923; placebo, n = 895) subjects were included in the analysis. The frequency of treatment-emergent adverse events (AEs) was 86% in the SLIT-tablet group and 83% in the placebo group, and the frequency of treatment-related AEs (TRAEs) was 59% and 23%, respectively. Most (98%) TRAEs were mild to moderate in severity. The 2 most common TRAEs with SLIT-tablet were Oral Pruritus (33%) and throat irritation (19%), which had a median onset of 1 day and recurrence of 14.5 and 5 days, respectively. In all, 8% of subjects in the SLIT-tablet group and 2% in the placebo group discontinued because of AEs. There were 7 serious AEs assessed as related to SLIT-tablet, 1 systemic allergic reaction (severe with a drop in blood pressure), 3 epinephrine administrations, no eosinophilic esophagitis events, and no serious airway obstructions. The safety profile was similar in subjects across geographic regions and with and without asthma. Conclusions Pooled data indicate that short- and long-term timothy grass SLIT-tablet is well tolerated in children, regardless of geographic region. AEs were generally local, mild, and transient allergic reactions.
-
SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration.
Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2018Co-Authors: David I Bernstein, Bodil Svanholm Fogh, Harold S Nelson, Gordon Sussman, J. Kleine-tebbe, Jose A. Bardelas, Dorte Rehm, Hendrik NolteAbstract:Abstract Background Allergic rhinitis with or without conjunctivitis (AR/C) is common, necessitating evaluation of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet efficacy in various subgroups. Objective To evaluate 12 SQ-HDM efficacy and safety across subgroups, and the onset, duration, and recurrence of local application site reactions. Methods Subgroup (age, gender, race, asthma status, and allergen sensitization) efficacy was assessed using pooled data from two previously described trials of daily 12 SQ-HDM vs placebo for AR/C (N=2138). Efficacy was measured by average total combined rhinitis score (TCRS; rhinitis daily symptom plus medication score) during the last 8 weeks of treatment. Safety in subgroups and local application site reaction onset, duration, and recurrence were evaluated using pooled data from five previously described trials of SQ HDM SLIT-tablet (N=2923). Results There was significant (based on 95% CIs) reduction in TCRS with 12 SQ-HDM relative to placebo across all subgroups, with TCRS improvements ranging from 15%-25%. The AE profile was generally similar within subgroups. Approximately 95% of local application site reactions were mild-to-moderate in severity. Median duration on day 1 of treatment for the most common local application site reactions (throat irritation, Oral Pruritus, ear Pruritus, and lip swelling) ranged from 30-60 minutes; median first day of onset ranged from days 1-4 of treatment; median days that reactions recurred ranged from 3-12 days. Conclusion Treatment with 12 SQ-HDM consistently improved symptoms and was well tolerated in relevant subgroups of subjects with HDM AR/C. Local application site reactions to 12 SQ-HDM were typically mild-to-moderate and transient.
-
Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet
The Journal of Allergy and Clinical Immunology: In Practice, 2018Co-Authors: Hendrik Nolte, Bodil Svanholm Fogh, Bernt Husøy, Susan Lu, David I Bernstein, Gordon Sussman, Harold S NelsonAbstract:Background It has been recommended that sublingual immunotherapy (SLIT) safety be assessed using solicited adverse event (AE) collection methods. Objectives The objectives of this study were to describe the impact on the safety profile of SQ house dust mite (HDM) SLIT-tablet (12 SQ-HDM dose) when prespecified local application site reactions were solicited versus unsolicited, and discuss ramifications of AE solicitation. Methods Subjects were randomized to daily 12 SQ-HDM or placebo for up to 52 weeks in 4 double-blinded, multicenter trials. In one trial (NCT01700192; N = 1272), subjects documented daily the presence or absence of 15 World Allergy Organization-defined local application site reactions using a structured questionnaire of closed-ended questions (solicited AEs). Subjects in the other trials were not asked about specific AEs (unsolicited AEs), and AE data were pooled (N = 1287). Analysis was limited to adults aged 18 to 65 years. Results Whether AEs were solicited or unsolicited, the most common AEs leading to study discontinuation with 12 SQ-HDM were throat irritation and Oral Pruritus. Approximately 95% of treatment-related AEs were mild to moderate. Placebo-subtracted frequencies of local application site reactions associated with 12 SQ-HDM were higher when solicited versus unsolicited (ie, throat irritation, 46% vs 13%, respectively; Oral Pruritus, 47% vs 17%; ear Pruritus, 40% vs 4%; mouth swelling, 8% vs 2%; tongue ulceration, 10% vs 0%; mouth ulceration, 7% vs Conclusions Qualitatively, the safety profile of 12 SQ-HDM was similar when AEs were solicited versus unsolicited; hence, solicitation did not alter the safety profile. Higher observed frequencies of local application site reactions with AE solicitation may be partly due to suggestive reporting bias, as observed in placebo-treated subjects.
-
ADVERSE EVENT PROFILE OF SQ HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY TABLET AFTER TREATMENT INTERRUPTION
Annals of Allergy Asthma & Immunology, 2018Co-Authors: S. Tilles, Harold S Nelson, Bruce M. Prenner, Jennifer Maloney, I. Mosbech Smith, Hendrik NolteAbstract:Introduction The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is approved for daily administration for the treatment of HDM-induced allergic rhinitis. The adverse event (AE) profile following treatment interruption was evaluated. Methods Safety data from 2 DBPC trials were pooled and analyzed for AEs reported at any point after a treatment interruption of ≥ 2 consecutive days for any reason. Data for the Europe/US approved dose 12 SQ-HDM (n=783) and placebo (n=782) are presented. IRB approval was obtained. Results In all, 977/1565 subjects (62%; 476/783, 12 SQ-HDM; 501/782, placebo) reported a treatment interruption for any reason. Median interruption duration was 7 days for 12 SQ-HDM and 8 days for placebo. The proportion of subjects who experienced AEs at any point after treatment re-initiation was similar between 12 SQ-HDM (226/783 [29%]) and placebo (203/782 [26%]). Most AEs after treatment re-initiation were assessed by the investigator as mild or moderate in severity. No systemic allergic reactions, epinephrine administrations, or severe local swellings were reported after treatment re-initiation. In the 12 SQ-HDM group, the most frequently reported AEs after re-initiation were Oral Pruritus (8%), throat irritation (8%), and ear Pruritus (7%); the frequencies of these AEs with placebo were 1%, 2%, and 1%, respectively. This AE profile characterized by local application site reactions is consistent with the known safety profile of the SQ HDM SLIT-tablet. Conclusions Safety data after short-term interruption of SQ HDM SLIT-tablet treatment do not indicate a safety signal after tablet re-initiation. The safety profile after long-term treatment interruption was not determined.
-
Sublingual immunotherapy tablets as a disease-modifying add-on treatment option to pharmacotherapy for allergic rhinitis and asthma.
Postgraduate medicine, 2017Co-Authors: Stephen Brunton, Harold S Nelson, David I Bernstein, Simon Lawton, Hendrik NolteAbstract:Allergic rhinitis (AR) with or without conjunctivitis (AR/C) is associated with a significant health and economic burden, and is often accompanied by asthma. Pharmacotherapies are the mainstay treatment options for AR and asthma, but guidelines also recommend allergy immunotherapy (AIT). Unlike pharmacotherapies, AIT has the ability to modify the underlying immunologic mechanisms of AR and asthma with the potential for long-term benefits after treatment is discontinued. Immunotherapy may also prevent progression of AR/C to asthma. Sublingual immunotherapy (SLIT)-tablets are a self-administered alternative to subcutaneous immunotherapy that provide the benefits of AIT without the cost and inconvenience of frequent office visits or the discomfort of injections. SLIT-tablets are also an option that can be utilized by primary care clinicians. Pharmacotherapies are generally effective in mild disease although a number of patients remain uncontrolled. SLIT-tablets have proven efficacy for AR in adults, children, and poly-sensitized allergic patients. Indirect comparisons indicate that SLIT-tablets have superior or comparable efficacy compared with traditional pharmacotherapies for seasonal AR, and superior efficacy for perennial AR. House dust mite (HDM) SLIT-tablets have also demonstrated clinically relevant benefits for asthma, with significant observed reductions in daily inhaled corticosteroid use, risk of asthma exacerbations, and asthma symptoms. SLIT-tablets are well tolerated, with minimal risk of systemic allergic reactions. The most common treatment-related adverse events are Oral site reactions such as Oral Pruritus and throat irritation. Based on the favorable efficacy and safety profile, as well as the convenience of at-home Oral administration and disease-modifying effects, SLIT-tablets should be considered as an alternative or add-on treatment to pharmacotherapy for AR/C, and as an add-on treatment for HDM allergic asthma.
Robert K. Zeldin - One of the best experts on this subject based on the ideXlab platform.
-
Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber
The Journal of allergy and clinical immunology, 2016Co-Authors: Michel Roux, Philippe Devillier, William H. Yang, A. Montagut, Kathy Abiteboul, Agnès Viatte, Robert K. ZeldinAbstract:Background In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis. Objectives We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber. Methods In this randomized, double-blind study, adults with HDM-associated allergic rhinitis were given a daily sublingual tablet containing placebo or STG320 at a dose of 500IR, 300IR, or 100IR (IR, index of reactivity) for 6 months. Participants recorded their rhinitis symptoms during 4-hour HDM EEC challenges at randomization and months 1, 2, 4, and 6. The primary efficacy end point was the change from baseline to end of treatment in the area under the curve of the rhinitis total symptom score (Ch BL AUC RTSS 0-4h ). Differences from the placebo group were analyzed by analysis of covariance. Adverse events (AEs) and routine safety parameters were recorded. Results A total of 355 subjects were randomized to 1 of 4 groups: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), or placebo (n = 87). The least squares mean differences from placebo in Ch BL AUC RTSS 0-4h for the 500IR, 300IR, and 100IR groups indicated a dose-dependent effect, with reductions in symptom scores of 33%, 29%, and 20%, respectively. The most frequent AEs were throat irritation and Oral Pruritus. There were no reports of anaphylaxis or reports consistent with severe laryngopharyngeal disorders and no use of epinephrine. AEs leading to premature discontinuations were more common in the 500IR group. Conclusions A dose-dependent effect of sublingual HDM immunotherapy was demonstrated in this environmental exposure chamber study, supporting further development of this treatment.
-
Safety of the 300 IR and 500 IR Doses of a House Dust Mite Allergen Extracts Sublingual Tablet in Adults with Allergic Rhinitis
Journal of Allergy and Clinical Immunology, 2015Co-Authors: Hélène Nguyen, Michel Roux, Josiane Cognet-sicé, Robert K. ZeldinAbstract:U E S D A Y 868 Safety of the 300 IR and 500 IR Doses of a House Dust Mite Allergen Extracts Sublingual Tablet in Adults with Allergic Rhinitis H el ene Nguyen, PharmD, Michel Roux, MD, Josiane CognetSic e, PharmD, Robert K. Zeldin, MD; Stallergenes S.A., Antony, France. RATIONALE: The efficacy of two doses (300IR and 500IR) of house dust mite (HDM) sublingual tablets was demonstrated in a randomized, DBPC study in patients with HDM-associated allergic rhinitis. Here we present the safety of this treatment. METHODS: Adults (18-50 years) with medically confirmed HDMassociated allergic rhinitis for at least one year were randomized to receive 300IR or 500IR HDM tablet or placebo once daily for one year and were followed for the subsequent year. Adverse events (AE) were monitored throughout the study and analyzed descriptively. All patients who received at least one dose of the investigational product were included in the safety set. RESULTS: 509 patients (300IR5170, 500IR5169, Placebo5170) were randomized and received at least one dose. 88% (300IR), 83% (500IR) and 80% (Placebo) reported at least one AE on treatment (TEAE). The most common TEAEs reported in the active groups were mild or moderate application site reactions i.e., Oral Pruritus (25-30% of patients), throat irritation (21-24%) and mouth edema (12-17%), which mostly occurred within the first month of treatment. Nine participants experienced serious TEAEs of which 4 were considered drug-related: pharyngeal edema (300IR), eczema (300IR), moderate respiratory distress related to a sublingual edema (500IR), and urticaria (Placebo); all recovered. Fortytwo patients (300IR517, 500IR520, and Placebo55) withdrew from the study due to a TEAE, most commonly pharyngeal edema, dyspepsia, nausea and mouth edema. CONCLUSIONS: Treatment with HDM sublingual tablets at doses of 300IR and 500IR was associated with a favorable safety profile. There was no appreciable difference in tolerability between the tested doses.
-
clinical efficacy of 300ir 5 grass pollen sublingual tablet in a us study the importance of allergen specific serum ige
The Journal of Allergy and Clinical Immunology, 2012Co-Authors: Thomas B. Casale, David I Bernstein, M Melac, A Nayak, Peter Socrates Creticos, Laurence Ambroisine, Robert K. ZeldinAbstract:Background Previous trials have demonstrated the efficacy, safety, and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen–induced allergic rhinoconjunctivitis. Objectives We sought to evaluate the efficacy and safety of 300 index of reactivity (IR) 5-grass pollen sublingual tablet in US adults. Methods Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater (scale, 0-18) during the previous grass pollen season were randomized in a double-blind, placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season. The primary efficacy end point was the daily Combined Score (CS; scale, 0-3), which integrates symptoms and rescue medication use. Results Four hundred seventy-three participants were randomized. The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group (least-squares mean difference: −0.13; 95% CI, −0.19 to −0.06; P = .0003; relative reduction: 28.2%; 95% CI, 13.0% to 43.4%). In placebo-treated participants, the daily CS least-squares mean was 0.32 in the subgroup with baseline timothy grass–specific serum IgE of less than 0.1 kU/L (n = 23) and 0.46 in those with baseline timothy grass–specific serum IgE of 0.1 kU/L or greater (n = 204). The most frequent reported adverse events were Oral Pruritus, throat irritation, and nasopharyngitis. There were no reports of anaphylaxis, and no actively treated participant received epinephrine. Conclusion In US adults with grass pollen–induced allergic rhinoconjunctivitis, preseasonal and coseasonal treatment with 300IR 5-grass pollen sublingual tablet demonstrated clinically meaningful efficacy, especially in study subjects with measurable timothy grass–specific serum IgE. Use of 300IR 5-grass pollen sublingual tablet was safe and well tolerated. A requirement for a measurable level of allergen-specific serum IgE should be considered in future studies in this field.
Christian Weißhaar - One of the best experts on this subject based on the ideXlab platform.
-
Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy
The Journal of Allergy and Clinical Immunology, 2009Co-Authors: Albrecht Bufe, Roland Knecht, Bente Tholstrup, Peter Eberle, Eivy Franke-beckmann, Jürgen Funck, Martin Kimmig, Ludger Klimek, V. Stephan, Christian WeißhaarAbstract:Background Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended. Objective To investigate the efficacy of treatment with the grass tablet on grass pollen–induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children. Methods A total of 253 children age 5 to 16 years, with grass pollen–induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores. Results The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was Oral Pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related. Conclusion Immunotherapy with the grass tablet reduced grass pollen–induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.
Peter Eberle - One of the best experts on this subject based on the ideXlab platform.
-
An observational, real-life safety study of a 5-grass pollen sublingual tablet in children and adolescents
Pediatric Allergy and Immunology, 2014Co-Authors: Peter Eberle, Helmut Brueck, Ralph Gall, Meike Hadler, Jochen Sieber, Efstrathios KaragiannisAbstract:Background The safety and efficacy of pre- and coseasonal sublingual allergen immunotherapy (SLIT) with a 5-grass pollen sublingual tablet have been demonstrated in a randomized clinical trial (RCT) in children and adolescents. Observational, ‘real-life’ studies can usefully complement the results of RCTs. Methods A prospective, open-label, observational, multicentre post-marketing study of children and adolescents (aged 5–17, with grass pollen-induced allergic rhinitis) treated with the 5-grass pollen sublingual tablet was performed between June 2009 and January 2011 in Germany. Adverse events (AEs) were recorded during consultations with the investigating physicians; AEs judged to have at least a possible causal link to the tablet were classified as adverse drug reactions (ADRs). Results Eight hundred and forty-nine patients were enrolled (by 207 investigating physicians), 829 (mean ± s.d. age: 10.9 ± 3.3 yr) completed the study without major protocol deviations, and 796 were fully documented with respect to AEs. Ninety-four of the 796 patients (11.8%) experienced at least one ADR on the first day of SLIT and 218 (27.4%) experienced at least one ADR during the study. Four hundred and sixty-six of the 596 ADRs (78.2%) were mild or moderate. The most common ADRs were throat irritation (19.1% of the reactions), Oral paresthesia (8.2%), Oral Pruritus (6.5%) and oedema mouth (6.2%). Serious ADRs occurred in five patients. No epinephrine use was reported. Seventy-six of the 829 patients (9.2%) discontinued SLIT due to AEs. Tolerability was judged to be good or very good by patients (84.7%), parents (87.0%) and investigators (89.7%). Conclusions In clinical practice, pre- and coseasonal treatment with a 5-grass pollen sublingual tablet is safe and well tolerated in children and adolescents.
-
An observational, real‐life safety study of a 5‐grass pollen sublingual tablet in children and adolescents
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2014Co-Authors: Peter Eberle, Helmut Brueck, Ralph Gall, Meike Hadler, Jochen Sieber, Efstrathios KaragiannisAbstract:Background The safety and efficacy of pre- and coseasonal sublingual allergen immunotherapy (SLIT) with a 5-grass pollen sublingual tablet have been demonstrated in a randomized clinical trial (RCT) in children and adolescents. Observational, ‘real-life’ studies can usefully complement the results of RCTs. Methods A prospective, open-label, observational, multicentre post-marketing study of children and adolescents (aged 5–17, with grass pollen-induced allergic rhinitis) treated with the 5-grass pollen sublingual tablet was performed between June 2009 and January 2011 in Germany. Adverse events (AEs) were recorded during consultations with the investigating physicians; AEs judged to have at least a possible causal link to the tablet were classified as adverse drug reactions (ADRs). Results Eight hundred and forty-nine patients were enrolled (by 207 investigating physicians), 829 (mean ± s.d. age: 10.9 ± 3.3 yr) completed the study without major protocol deviations, and 796 were fully documented with respect to AEs. Ninety-four of the 796 patients (11.8%) experienced at least one ADR on the first day of SLIT and 218 (27.4%) experienced at least one ADR during the study. Four hundred and sixty-six of the 596 ADRs (78.2%) were mild or moderate. The most common ADRs were throat irritation (19.1% of the reactions), Oral paresthesia (8.2%), Oral Pruritus (6.5%) and oedema mouth (6.2%). Serious ADRs occurred in five patients. No epinephrine use was reported. Seventy-six of the 829 patients (9.2%) discontinued SLIT due to AEs. Tolerability was judged to be good or very good by patients (84.7%), parents (87.0%) and investigators (89.7%). Conclusions In clinical practice, pre- and coseasonal treatment with a 5-grass pollen sublingual tablet is safe and well tolerated in children and adolescents.
-
Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy
The Journal of Allergy and Clinical Immunology, 2009Co-Authors: Albrecht Bufe, Roland Knecht, Bente Tholstrup, Peter Eberle, Eivy Franke-beckmann, Jürgen Funck, Martin Kimmig, Ludger Klimek, V. Stephan, Christian WeißhaarAbstract:Background Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended. Objective To investigate the efficacy of treatment with the grass tablet on grass pollen–induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children. Methods A total of 253 children age 5 to 16 years, with grass pollen–induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores. Results The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was Oral Pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related. Conclusion Immunotherapy with the grass tablet reduced grass pollen–induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.