PMID- 23870670 OWN - NLM STAT- MEDLINE DCOM- 20140313 LR - 20131227 IS - 1097-6825 (Electronic) IS - 0091-6749 (Linking) VI - 133 IP - 1 DP - 2014 Jan TI - Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitis to ragweed pollen. PG - 121-9.e1-2 LID - S0091-6749(13)00907-X [pii] LID - 10.1016/j.jaci.2013.05.032 [doi] AB - BACKGROUND: Specific immunotherapy acts to modify the underlying cause of allergic rhinoconjunctivitis. Addition of adjuvants, such as monophosphoryl lipid A (MPL), might allow for efficacious and safe treatment with only 4 injections administered preseasonally, which is in contrast to most available schedules requiring long injection courses. OBJECTIVE: The primary objective was to assess the clinical efficacy of Ragweed MATA MPL (short ragweed pollen allergoid adsorbed to L-Tyrosine + MPL) versus placebo in reducing allergic rhinoconjunctivitis symptoms caused by ragweed pollen in an environmental exposure chamber (EEC) 3 weeks after treatment. METHODS: This was a randomized, double-blind, placebo-controlled phase IIb study to evaluate the clinical efficacy and safety of Ragweed MATA MPL compared with placebo by using controlled ragweed pollen exposure in an EEC. Two hundred twenty-eight patients with a history of ragweed allergy and positive skin prick test responses to ragweed were randomized and received 4 weekly injections of active treatment or placebo. Total nasal and nonnasal symptom scores were obtained in the EEC before and after treatment. RESULTS: Mean improvement in total symptom scores in the Ragweed MATA MPL group was statistically significantly greater than in the placebo group (relative mean improvement of active vs placebo, 48%; P < .05; median improvement, 82%). The majority of adverse events (AEs) experienced by subjects were mild injection-site reactions. No severe systemic AEs or serious AEs occurred during the study. CONCLUSION: This study demonstrated that an ultrashort course of Ragweed MATA MPL is efficacious in reducing allergy symptoms in patients with seasonal allergic rhinitis and that it is well tolerated. CI - Copyright (c) 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved. FAU - Patel, Piyush AU - Patel P AD - Allied Research International, Mississauga, Ontario, Canada. Electronic address: PPatel@inflamaxresearch.com. FAU - Holdich, Tom AU - Holdich T AD - Allergy Therapeutics, West Sussex, United Kingdom. FAU - Fischer von Weikersthal-Drachenberg, Karl J AU - Fischer von Weikersthal-Drachenberg KJ AD - Bencard Allergie, Munich, Germany. FAU - Huber, Birgit AU - Huber B AD - Bencard Allergie, Munich, Germany. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130716 PL - United States TA - J Allergy Clin Immunol JT - The Journal of allergy and clinical immunology JID - 1275002 RN - 0 (Allergens) RN - 0 (Antigens, Plant) RN - 0 (Lipid A) RN - 0 (Plant Extracts) RN - 0 (ragweed MATA MPL) RN - 0 (ragweed pollen) RN - Ragweed Sensitivity SB - IM MH - Adolescent MH - Adult MH - Aged MH - Allergens/adverse effects/immunology MH - Ambrosia/*immunology MH - Antigens, Plant/*adverse effects MH - Clinical Protocols MH - Conjunctivitis, Allergic/*therapy MH - Desensitization, Immunologic/*methods MH - Environmental Exposure/adverse effects MH - Female MH - Humans MH - Hypersensitivity, Immediate/*therapy MH - Lipid A/*analogs & derivatives/therapeutic use MH - Male MH - Middle Aged MH - Plant Extracts/*adverse effects/*therapeutic use MH - Rhinitis, Allergic, Seasonal/*therapy MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - AE OT - AR OT - Adverse event OT - Allergic rhinoconjunctivitis OT - EEC OT - Environmental exposure chamber OT - ITT OT - Intention to treat OT - MPL OT - Monophosphoryl lipid A OT - PP OT - Per protocol OT - RQLQ OT - Rhinoconjunctivitis Quality of Life Questionnaire OT - SAR OT - SIT OT - SU OT - Seasonal allergic rhinitis OT - Specific immunotherapy OT - Standardized units OT - TSS OT - Total symptom score OT - environmental exposure chamber OT - ragweed OT - specific immunotherapy OT - ultrashort course EDAT- 2013/07/23 06:00 MHDA- 2014/03/14 06:00 CRDT- 2013/07/23 06:00 PHST- 2012/10/11 00:00 [received] PHST- 2013/04/19 00:00 [revised] PHST- 2013/05/22 00:00 [accepted] PHST- 2013/07/23 06:00 [entrez] PHST- 2013/07/23 06:00 [pubmed] PHST- 2014/03/14 06:00 [medline] AID - S0091-6749(13)00907-X [pii] AID - 10.1016/j.jaci.2013.05.032 [doi] PST - ppublish SO - J Allergy Clin Immunol. 2014 Jan;133(1):121-9.e1-2. doi: 10.1016/j.jaci.2013.05.032. Epub 2013 Jul 16.