- Email: [email protected]
Antidepressant & Anxiolytic Prescriptions Among Patients Receiving Allergen Immunotherapy
Abstracts S125
J ALLERGY CLIN IMMUNOL VOLUME 121, NUMBER 2
Reduction of Substance P in Nasal Lavage Fluid after Allergen Challenge of Mugwort Allergic Patients during Allergen Immunotherapy R. Gawlik1, B. Jawor1, B. Rogala1, L. M. DuBuske2; 1Silesian University School of Medicine, Zabrze, POLAND, 2Immunology Research Institute of New England, Gardner, MA. RATIONALE: Allergen specific immunotherapy (ASIT) may impact neuropeptides released into nasal lavage fluid (NLF) including substance P (SP). METHODS: 15 subjects (8 females and 7 males) mean age 33.0 6 7.8 years with symptoms during the previous mugwort pollen season were treated with ASIT as pre-seasonal weekly injections of a mugwort pollen allergoid (Allergovit) for 3 years. All had both positive skin prick tests to mugwort pollen allergen and elevated specific IgE to mugwort pollen (Phadia). The control group consisted of 9 untreated subjects. Nasal mugwort allergen challenge with subsequent lavage performed 15 minutes post-challenge was done by the method of Naclerio. The concentration of SP in NLF was determined by RIA (Incstar, USA). Nasal symptoms during the pollen seasons were recorded. RESULTS: Reduction of symptom scores occurred during the three years of ASIT. Levels of SP in NLF after nasal mugwort challenge in both groups prior to therapy were similar: ASIT group - SP 55.1 6 15.5 pg/ml versus control group- 54.3 6 10.1 pg/ml. SP levels in NLF 15 minutes after mugwort allergen challenge were significantly less after 1 year of ASIT versus controls (47.4 6 14.0 pg/ml versus 53.6 6 6.8 pg/l) with modest further decrease in SP levels in post-challenge NLF after 2 years of ASIT (42.2 6 9.6 pg/ml versus 51.2 6 9.2 pg/ml) and 3 years of ASIT (41.6 6 18.3 pg/ml versus 51.8 6 7.6 pg/ml). CONCLUSIONS: SP may play a role in nasal allergic responses to mugwort pollen. Decreased release of SP upon nasal allergen challenge occurs with each year of ASIT suggesting that ASIT reduces allergeninduced SP release.
483
Dose Effect of Sublingual Immunotherapy in the Treatment of Respiratory Allergic Diseases. Systematic Review and Metaregression of Randomized Clinical Trials, Double-Blind, Placebo-Controlled M. Penagos1,2, M. Calderon1,2, S. R. Durham1,2; 1Imperial College of London, London, UNITED KINGDOM, 2National Heart and Lung Institute, London, UNITED KINGDOM. RATIONALE: Recent randomized, double-blind, placebo-controlled clinical trials (RCTDBPC) comparing diverse doses of Sublingual Immunotherapy (SLIT) in the treatment of respiratory allergic diseases have demonstrated a clear dose-dependent effect. METHODS: In an attempt to determine whether the allergen SLIT dose is related to clinical outcomes, a comprehensive search of the EMBASE and MEDLINE databases up to July 31st, 2007 was conducted. The search strategy retrieved citations containing the subject SLIT limited to RCTDBPC combined with asthma and/or allergic rhinitis. Those studies that reported allergen dose in mass units and symptom and/or medication scores were included. A meta-regression analysis was performed. The cumulative dose and administration-time were considered as covariates. RESULTS: Forty-five RCTDBPC were identified; clinical scores were available in 41 studies and the allergen dose in mass units in 34. Thirty one studies met the inclusion criteria. Twelve studies used grasses, 9 house dust mites, 5 tree pollen and 5 weeds. The median administration-time for SLIT was 10 months (Range 3-36). Cumulative dose was variable, ranging from a monthly dose of 0.6 to 6,840 mg. Allergen dose was not significantly associated with lower clinical scores analyzed by the Meta-regression (p 5 0.07). When the covariate administration-time was analyzed, this was marginally associated with lower scores (p 5 0.048). CONCLUSIONS: This analysis was not able to demonstrate a significant effect of SLIT dose on clinical outcomes. Allergen diversity, manufacturing process, bioavailability, patients’ inclusion criteria and scores heterogeneity and treatment duration could influence the outcomes. Direct evaluations have to be conducted comparing dose schedules in RCTDBPC. Funding: Imperial College of London
484
Antidepressant & Anxiolytic Prescriptions Among Patients Receiving Allergen Immunotherapy B. J. McClimon, M. A. Rank, G. W. Volcheck; Mayo Clinic, Rochester, MN. RATIONALE: A correlation between depression and allergic disease has been reported but to our knowledge no data exists regarding antidepressant/ anxiolytic prescriptions in patients receiving allergen immunotherapy. METHODS: Electronic medication records of patients 18-50 years old receiving allergen immunotherapy at our institution from 2004-2006 were reviewed for anti-depressant/anxiolytic prescriptions. An age and gender matched control group of patients receiving primary care at our institution was also reviewed for anti-depressant/anxiolytic prescriptions. RESULTS: We identified 237 subjects and an equal number of gender/age matched controls. The average age of the allergen immunotherapy group was 36.7 years compared to 36.6 years in the control group. The groups consisted of 131 (55%) females and 106 (45%) males. We found 69 (29%) of 237 patients receiving immunotherapy were prescribed antidepressants or anxiolytics. In comparison, only 52 (22%) of 237 patients in our control group were prescribed these medications (p 5 0.09). In addition, we found 37% (49/131) of females receiving allergen immunotherapy were also prescribed anti-depressants/anxiolytics compared with 29% (38/131) in our control group. Nineteen percent (20/106) of males receiving allergen immunotherapy were prescribed antidepressants/anxiolytics while only 13% (14/106) in the control group were prescribed the medications. CONCLUSIONS: Nearly one third of patients receiving allergen immunotherapy were also prescribed antidepressants or anxiolytics. Further research will be helpful to clarify this relationship.
485
Efficacy of a Rush Immunotherapy with a Depigmented Polymerized Extract of Grass pollen using an Enviromental Challenge Chamber (ECC) A. Sager1, M. Braeutigam2, P. Badorrek3, N. Krug3; 1LETI Pharma GmbH, Witten, GERMANY, 2Novartis Pharma GmbH, Nuernberg, GERMANY, 3Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, GERMANY. RATIONALE: To avoid environmental variations the efficacy of a 5 weeks rush immunotherapy with DepigoidÒ Grass Mix was investigated in patients with allergic rhinitis under standardized ECC conditions. METHODS: Patient selection: 60 male and female patients aged 18 to 54 years with hay fever due to grass pollen sensitization were enrolled based on an at least moderate response upon 4000 Dactylis glomerata pollen grains/m3 within 2 hours in the ECC. Main exclusion criteria: Clinically significant sensitization against tree pollen, weed pollen and perennial allergens, persistent asthma (GINA II). Treatment: Immunotherapy was performed using with 1000 DPP/ml depigmented and polymerized allergenic extract of grass pollen. The rush treatment began with 0.2 ml followed by 0.3 ml after 30 min at day 1 and followed by 0.5 ml/week at weeks 1-5. Placebo treatment was performed identically using DepigoidÒ vehicle. Primary outcome was the change from baseline in the mean ’’Total Nasal Symptom Score’’ (TNSS) during the allergen challenge for the symptoms rhinorrhea, nasal congestion, sneezing and nasal itching on a scale from 0-3 (none -severe) for each symptom. RESULTS: Analysis was based on the ITT set (N 5 60) using an ANCOVA model. In patients with a baseline severity of TNSS 6 the prepost difference of the mean TNSS was -2.57 in the Depigoid Grass Mix and -1.38 in the placebo group. The overall difference between both treatments was statistically significant (p 5 0.03). CONCLUSIONS: Short-term rush immunotherapy with DepigoidÒ Grass Mix was effective and safe.
SUNDAY
482
J ALLERGY CLIN IMMUNOL VOLUME 121, NUMBER 2
Reduction of Substance P in Nasal Lavage Fluid after Allergen Challenge of Mugwort Allergic Patients during Allergen Immunotherapy R. Gawlik1, B. Jawor1, B. Rogala1, L. M. DuBuske2; 1Silesian University School of Medicine, Zabrze, POLAND, 2Immunology Research Institute of New England, Gardner, MA. RATIONALE: Allergen specific immunotherapy (ASIT) may impact neuropeptides released into nasal lavage fluid (NLF) including substance P (SP). METHODS: 15 subjects (8 females and 7 males) mean age 33.0 6 7.8 years with symptoms during the previous mugwort pollen season were treated with ASIT as pre-seasonal weekly injections of a mugwort pollen allergoid (Allergovit) for 3 years. All had both positive skin prick tests to mugwort pollen allergen and elevated specific IgE to mugwort pollen (Phadia). The control group consisted of 9 untreated subjects. Nasal mugwort allergen challenge with subsequent lavage performed 15 minutes post-challenge was done by the method of Naclerio. The concentration of SP in NLF was determined by RIA (Incstar, USA). Nasal symptoms during the pollen seasons were recorded. RESULTS: Reduction of symptom scores occurred during the three years of ASIT. Levels of SP in NLF after nasal mugwort challenge in both groups prior to therapy were similar: ASIT group - SP 55.1 6 15.5 pg/ml versus control group- 54.3 6 10.1 pg/ml. SP levels in NLF 15 minutes after mugwort allergen challenge were significantly less after 1 year of ASIT versus controls (47.4 6 14.0 pg/ml versus 53.6 6 6.8 pg/l) with modest further decrease in SP levels in post-challenge NLF after 2 years of ASIT (42.2 6 9.6 pg/ml versus 51.2 6 9.2 pg/ml) and 3 years of ASIT (41.6 6 18.3 pg/ml versus 51.8 6 7.6 pg/ml). CONCLUSIONS: SP may play a role in nasal allergic responses to mugwort pollen. Decreased release of SP upon nasal allergen challenge occurs with each year of ASIT suggesting that ASIT reduces allergeninduced SP release.
483
Dose Effect of Sublingual Immunotherapy in the Treatment of Respiratory Allergic Diseases. Systematic Review and Metaregression of Randomized Clinical Trials, Double-Blind, Placebo-Controlled M. Penagos1,2, M. Calderon1,2, S. R. Durham1,2; 1Imperial College of London, London, UNITED KINGDOM, 2National Heart and Lung Institute, London, UNITED KINGDOM. RATIONALE: Recent randomized, double-blind, placebo-controlled clinical trials (RCTDBPC) comparing diverse doses of Sublingual Immunotherapy (SLIT) in the treatment of respiratory allergic diseases have demonstrated a clear dose-dependent effect. METHODS: In an attempt to determine whether the allergen SLIT dose is related to clinical outcomes, a comprehensive search of the EMBASE and MEDLINE databases up to July 31st, 2007 was conducted. The search strategy retrieved citations containing the subject SLIT limited to RCTDBPC combined with asthma and/or allergic rhinitis. Those studies that reported allergen dose in mass units and symptom and/or medication scores were included. A meta-regression analysis was performed. The cumulative dose and administration-time were considered as covariates. RESULTS: Forty-five RCTDBPC were identified; clinical scores were available in 41 studies and the allergen dose in mass units in 34. Thirty one studies met the inclusion criteria. Twelve studies used grasses, 9 house dust mites, 5 tree pollen and 5 weeds. The median administration-time for SLIT was 10 months (Range 3-36). Cumulative dose was variable, ranging from a monthly dose of 0.6 to 6,840 mg. Allergen dose was not significantly associated with lower clinical scores analyzed by the Meta-regression (p 5 0.07). When the covariate administration-time was analyzed, this was marginally associated with lower scores (p 5 0.048). CONCLUSIONS: This analysis was not able to demonstrate a significant effect of SLIT dose on clinical outcomes. Allergen diversity, manufacturing process, bioavailability, patients’ inclusion criteria and scores heterogeneity and treatment duration could influence the outcomes. Direct evaluations have to be conducted comparing dose schedules in RCTDBPC. Funding: Imperial College of London
484
Antidepressant & Anxiolytic Prescriptions Among Patients Receiving Allergen Immunotherapy B. J. McClimon, M. A. Rank, G. W. Volcheck; Mayo Clinic, Rochester, MN. RATIONALE: A correlation between depression and allergic disease has been reported but to our knowledge no data exists regarding antidepressant/ anxiolytic prescriptions in patients receiving allergen immunotherapy. METHODS: Electronic medication records of patients 18-50 years old receiving allergen immunotherapy at our institution from 2004-2006 were reviewed for anti-depressant/anxiolytic prescriptions. An age and gender matched control group of patients receiving primary care at our institution was also reviewed for anti-depressant/anxiolytic prescriptions. RESULTS: We identified 237 subjects and an equal number of gender/age matched controls. The average age of the allergen immunotherapy group was 36.7 years compared to 36.6 years in the control group. The groups consisted of 131 (55%) females and 106 (45%) males. We found 69 (29%) of 237 patients receiving immunotherapy were prescribed antidepressants or anxiolytics. In comparison, only 52 (22%) of 237 patients in our control group were prescribed these medications (p 5 0.09). In addition, we found 37% (49/131) of females receiving allergen immunotherapy were also prescribed anti-depressants/anxiolytics compared with 29% (38/131) in our control group. Nineteen percent (20/106) of males receiving allergen immunotherapy were prescribed antidepressants/anxiolytics while only 13% (14/106) in the control group were prescribed the medications. CONCLUSIONS: Nearly one third of patients receiving allergen immunotherapy were also prescribed antidepressants or anxiolytics. Further research will be helpful to clarify this relationship.
485
Efficacy of a Rush Immunotherapy with a Depigmented Polymerized Extract of Grass pollen using an Enviromental Challenge Chamber (ECC) A. Sager1, M. Braeutigam2, P. Badorrek3, N. Krug3; 1LETI Pharma GmbH, Witten, GERMANY, 2Novartis Pharma GmbH, Nuernberg, GERMANY, 3Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, GERMANY. RATIONALE: To avoid environmental variations the efficacy of a 5 weeks rush immunotherapy with DepigoidÒ Grass Mix was investigated in patients with allergic rhinitis under standardized ECC conditions. METHODS: Patient selection: 60 male and female patients aged 18 to 54 years with hay fever due to grass pollen sensitization were enrolled based on an at least moderate response upon 4000 Dactylis glomerata pollen grains/m3 within 2 hours in the ECC. Main exclusion criteria: Clinically significant sensitization against tree pollen, weed pollen and perennial allergens, persistent asthma (GINA II). Treatment: Immunotherapy was performed using with 1000 DPP/ml depigmented and polymerized allergenic extract of grass pollen. The rush treatment began with 0.2 ml followed by 0.3 ml after 30 min at day 1 and followed by 0.5 ml/week at weeks 1-5. Placebo treatment was performed identically using DepigoidÒ vehicle. Primary outcome was the change from baseline in the mean ’’Total Nasal Symptom Score’’ (TNSS) during the allergen challenge for the symptoms rhinorrhea, nasal congestion, sneezing and nasal itching on a scale from 0-3 (none -severe) for each symptom. RESULTS: Analysis was based on the ITT set (N 5 60) using an ANCOVA model. In patients with a baseline severity of TNSS 6 the prepost difference of the mean TNSS was -2.57 in the Depigoid Grass Mix and -1.38 in the placebo group. The overall difference between both treatments was statistically significant (p 5 0.03). CONCLUSIONS: Short-term rush immunotherapy with DepigoidÒ Grass Mix was effective and safe.
SUNDAY
482