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Clinical Outcome and Tolerability of a 2-Year Sublingual Allergen Immunotherapy (AIT) with a 5-Grass Pollen Tablet in Polyallergic Patients – Real-Life Medical Practice Data
Abstracts AB267
J ALLERGY CLIN IMMUNOL VOLUME 135, NUMBER 2
Safety of the 300 IR and 500 IR Doses of a House Dust Mite Allergen Extracts Sublingual Tablet in Adults with Allergic Rhinitis Helene Nguyen, PharmD, Michel Roux, MD, Josiane CognetSice, 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.
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Clinical Outcome and Tolerability of a 2-Year Sublingual Allergen Immunotherapy (AIT) with a 5-Grass Pollen Tablet in Polyallergic Patients – Real-Life Medical Practice Data Meike Hadler1, Efstrathios Karagiannis1, Kija Shah-Hosseini2, Ralph Mosges, MD, FAAAAI2; 1Stallergenes GmbH, Kamp-Lintfort, Germany, 2 Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), Cologne, Germany. RATIONALE: Patients with respiratory allergies are often polyallergic, i.e. allergic to more than one allergen. Clinical trials have shown that these patients can effectively and safely be treated with AIT, however data from real-life medical practice remain scarce. METHODS: We performed a prospective, open, non-controlled, multicenter, observational study of 1482 patients with grass pollen-induced allergic rhinoconjunctivitis (RC) in Germany to assess the clinical outcome, safety and tolerability of a pre-/coseasonal AIT with a 5-grass pollen tablet over 2 treatment seasons. Here we report the results in polyallergic patients with or without concomitant AIT (either SLIT or SCIT). RESULTS: 1011 polyallergic patients participated. 76.8% received only the 5-grass pollen AIT (5w/o AIT), 23.2% were treated concomitantly with another AIT (5with AIT). For the ‘‘with AIT’’ patients, the RC score (scale 0-6; severity rhinitis [0-3] + conjunctivitis [0-3]) was reduced by 62% (from 4.19 in the grass pollen season preceding AIT (Y0) to 2.02 (1st study year (Y1)) and 1.60 (2nd study year (Y2))). The RC score reduction in ‘‘w/o AIT’’ patients was 63% (from 4.18 (Y0) to 2.15 (Y1) and 1.55 (Y2)). Treatment was well tolerated. 18.0% of ‘‘with AIT’’ and 17.5% of ‘‘w/o AIT’’ patients experienced adverse drug reactions (ADRs). The most frequent ADRs were throat irritation and oral paraesthesia in both subgroups. Serious ADRs occurred in 4 of the ‘‘w/o AIT’’ and none of the ‘‘with AIT’’ patients. CONCLUSIONS: In real-life practice, grass pollen polyallergic patients treated with 5-grass pollen AIT reported similar tolerability and symptom reduction regardless of concomitant use of AIT.
870
Sustained Efficacy Assessed By Number Needed to Treat for Timothy Grass Immunotherapy Tablets in the Treatment of Allergic Rhinitis with/without Conjunctivitis up to 2 Years after 3 Years of Treatment Stephen R. Durham, MA, MD, FRCP1, Amarjot Kaur, PhD2, Gary Koch, PhD3, Jay M. Portnoy4, Jens S. Andersen, PhD5, Ziliang Li, PhD2, Jennifer Maloney, MD2, Hendrik Nolte, MD, PhD2; 1Royal Brompton and Harefield Hospitals NHS Trust, London, United Kingdom, 2 Merck & Co., Inc., Whitehouse Station, NJ, 3Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 4Department of Pediatric Allergy & Immunology, Children’s Mercy Hospital & Clinics, Kansas City, MO, 5ALK-Abello, Hørsholm, Denmark. RATIONALE: Number needed to treat (NNT) is a quantitative measure to assess relative treatment efficacy; lower NNT indicates greater efficacy. Using NNT, we explored efficacy for up to 2 years after 3-years of Timothy grass sublingual immunotherapy tablet (SLIT-tablet) treatment for allergic rhinitis with/without conjunctivitis (AR/C). METHODS: Yearly NNT was calculated for grass SLIT-tablet 2800 BAU/ 75,000 SQ-T (Merck/ALK-Abello [MK-7243]) using data from a randomized, double-blind, placebo-controlled trial (n5634; 3-year treatment+2-year follow-up; NCT00227279). In addition, overall NNT was calculated from pooled single-season data (n53094) from grass SLITtablet pivotal trials. In the absence of an established responder definition, NNT was based on 2 exploratory post-hoc responder definitions. _50% well-days (symptom score of Definition-1 was achievement of > none or mild for each of the 6 symptoms measured, and no rescue medication use) during pollen season. Missing data were considered nonwell2days. Definition-2 was achievement of average total combined _3 during pollen season (;10% of symptom+medication score (TCS) < observed range as cutoff). Subjects were included in Definition-2 analysis for a given year when average TCS was non-missing. _50% well-days definition, NNT was 5.9, 5.2, 6.9, RESULTS: Using the > _3 6.0, and 6.4 for years 1, 2, 3, 4, and 5, respectively. Using the TCS < definition, NNT was 6.4, 4.8, 5.3, 7.3, and 7.3 for years 1, 2, 3, 4, and 5, _50% well-days definition and respectively. Overall NNTwas 7.9 using the > _3 threshold. 9.4 using the TCS < CONCLUSIONS: NNT confirms favorable and sustained efficacy of grass SLIT-tablet for AR/C up to 2 years after a 3-year treatment period.
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J ALLERGY CLIN IMMUNOL VOLUME 135, NUMBER 2
Safety of the 300 IR and 500 IR Doses of a House Dust Mite Allergen Extracts Sublingual Tablet in Adults with Allergic Rhinitis Helene Nguyen, PharmD, Michel Roux, MD, Josiane CognetSice, 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.
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Clinical Outcome and Tolerability of a 2-Year Sublingual Allergen Immunotherapy (AIT) with a 5-Grass Pollen Tablet in Polyallergic Patients – Real-Life Medical Practice Data Meike Hadler1, Efstrathios Karagiannis1, Kija Shah-Hosseini2, Ralph Mosges, MD, FAAAAI2; 1Stallergenes GmbH, Kamp-Lintfort, Germany, 2 Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), Cologne, Germany. RATIONALE: Patients with respiratory allergies are often polyallergic, i.e. allergic to more than one allergen. Clinical trials have shown that these patients can effectively and safely be treated with AIT, however data from real-life medical practice remain scarce. METHODS: We performed a prospective, open, non-controlled, multicenter, observational study of 1482 patients with grass pollen-induced allergic rhinoconjunctivitis (RC) in Germany to assess the clinical outcome, safety and tolerability of a pre-/coseasonal AIT with a 5-grass pollen tablet over 2 treatment seasons. Here we report the results in polyallergic patients with or without concomitant AIT (either SLIT or SCIT). RESULTS: 1011 polyallergic patients participated. 76.8% received only the 5-grass pollen AIT (5w/o AIT), 23.2% were treated concomitantly with another AIT (5with AIT). For the ‘‘with AIT’’ patients, the RC score (scale 0-6; severity rhinitis [0-3] + conjunctivitis [0-3]) was reduced by 62% (from 4.19 in the grass pollen season preceding AIT (Y0) to 2.02 (1st study year (Y1)) and 1.60 (2nd study year (Y2))). The RC score reduction in ‘‘w/o AIT’’ patients was 63% (from 4.18 (Y0) to 2.15 (Y1) and 1.55 (Y2)). Treatment was well tolerated. 18.0% of ‘‘with AIT’’ and 17.5% of ‘‘w/o AIT’’ patients experienced adverse drug reactions (ADRs). The most frequent ADRs were throat irritation and oral paraesthesia in both subgroups. Serious ADRs occurred in 4 of the ‘‘w/o AIT’’ and none of the ‘‘with AIT’’ patients. CONCLUSIONS: In real-life practice, grass pollen polyallergic patients treated with 5-grass pollen AIT reported similar tolerability and symptom reduction regardless of concomitant use of AIT.
870
Sustained Efficacy Assessed By Number Needed to Treat for Timothy Grass Immunotherapy Tablets in the Treatment of Allergic Rhinitis with/without Conjunctivitis up to 2 Years after 3 Years of Treatment Stephen R. Durham, MA, MD, FRCP1, Amarjot Kaur, PhD2, Gary Koch, PhD3, Jay M. Portnoy4, Jens S. Andersen, PhD5, Ziliang Li, PhD2, Jennifer Maloney, MD2, Hendrik Nolte, MD, PhD2; 1Royal Brompton and Harefield Hospitals NHS Trust, London, United Kingdom, 2 Merck & Co., Inc., Whitehouse Station, NJ, 3Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 4Department of Pediatric Allergy & Immunology, Children’s Mercy Hospital & Clinics, Kansas City, MO, 5ALK-Abello, Hørsholm, Denmark. RATIONALE: Number needed to treat (NNT) is a quantitative measure to assess relative treatment efficacy; lower NNT indicates greater efficacy. Using NNT, we explored efficacy for up to 2 years after 3-years of Timothy grass sublingual immunotherapy tablet (SLIT-tablet) treatment for allergic rhinitis with/without conjunctivitis (AR/C). METHODS: Yearly NNT was calculated for grass SLIT-tablet 2800 BAU/ 75,000 SQ-T (Merck/ALK-Abello [MK-7243]) using data from a randomized, double-blind, placebo-controlled trial (n5634; 3-year treatment+2-year follow-up; NCT00227279). In addition, overall NNT was calculated from pooled single-season data (n53094) from grass SLITtablet pivotal trials. In the absence of an established responder definition, NNT was based on 2 exploratory post-hoc responder definitions. _50% well-days (symptom score of Definition-1 was achievement of > none or mild for each of the 6 symptoms measured, and no rescue medication use) during pollen season. Missing data were considered nonwell2days. Definition-2 was achievement of average total combined _3 during pollen season (;10% of symptom+medication score (TCS) < observed range as cutoff). Subjects were included in Definition-2 analysis for a given year when average TCS was non-missing. _50% well-days definition, NNT was 5.9, 5.2, 6.9, RESULTS: Using the > _3 6.0, and 6.4 for years 1, 2, 3, 4, and 5, respectively. Using the TCS < definition, NNT was 6.4, 4.8, 5.3, 7.3, and 7.3 for years 1, 2, 3, 4, and 5, _50% well-days definition and respectively. Overall NNTwas 7.9 using the > _3 threshold. 9.4 using the TCS < CONCLUSIONS: NNT confirms favorable and sustained efficacy of grass SLIT-tablet for AR/C up to 2 years after a 3-year treatment period.
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