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Tabar A.I.,Hospital Virgen del Camino | Arroabarren E.,Hospital Universitario Donostia | Echechipia S.,Hospital Virgen del Camino | Garcia B.E.,Hospital Virgen del Camino | And 2 more authors.
Journal of Allergy and Clinical Immunology | Year: 2011

Background: Specific immunotherapy (SIT) duration for respiratory allergy is currently based on individual decisions. Objective: To evaluate the differences in clinical efficacy of SIT as a result of the duration between the current recommended limits (3-5 years). Methods: A 5-year prospective, controlled clinical trial of SIT blind until the first year and randomization to a 3-year (IT3) or 5-year (IT5) course was conducted. Of the 239 patients with respiratory allergy caused by D pteronyssinus initially included, 142 completed 3 years of SIT with good compliance. Twenty-seven controls were included at the third year. Efficacy of SIT after 3 (T3) and 5 (T5) years was assessed by using clinical scores, visual analog scales (VASs), rhinitis (RQLQ) and asthma (AQLQ) quality of life questionnaires, skin tests, and serum immunoglobulins. Results: At T3, significant reductions were observed in rhinitis (44% in IT3 and 50% in IT5; P < .001), asthma (80.9 % in IT3 and 70.9% in IT5; P < .001) scores, VAS (P < .001 in both), RQLQ (P < .001 in both) and AQLQ (P < .001 in both). At T5, the clinical benefit was maintained in both groups, and IT5 patients presented additional decreases (19%; P = .019) in rhinitis scores. At Tf, specific IgG 4 measurements were lower in IT3 (P = .03) without detecting differences in IT5. An increase in asthma score of 133% was the only difference observed in controls. Conclusion: Clinical improvement is obtained with 3 years of D pteronyssinus SIT. Two additional years of SIT add clinical benefit in rhinitis only. © 2010 American Academy of Allergy, Asthma & Immunology. Source


Nayak A.S.,Wheeze and Itch Associates LLC | Atiee G.J.,ICON Development Solutions | Dige E.,ALK Abello | Maloney J.,Merck And Co. | Nolte H.,Merck And Co.
Allergy and Asthma Proceedings | Year: 2012

A sublingually administered allergy immunotherapy tablet (AIT) is under development to treat ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). This study investigates the optimal tolerable dose of oncedaily ragweed pollen AIT. Subjects 18-50 years old with ragweed-induced ARC were enrolled at two U.S. centers in a double-blind, placebo-controlled, dose-escalation study outside ragweed season. Groups (12 subjects each) were to be randomized 3:1 to 28 days of active treatment (groups assigned in sequence to 3, 6, 12, 24, 50, or 100 Amb a 1 U, without dose buildup at any level) or matching placebo. Recruitment to 50 Amb a 1-U was discontinued because of adverse events (AEs) after four AIT subjects were enrolled; 100 1 unit of ambrosia artemislifolia major allergen 1 was not initiated. Fifty-three subjects were randomized (AIT, n = 40; placebo, n = 13); four discontinued, all because of AEs (AIT, n = 3; placebo, n = 1). Treatment-related AEs (TRAEs) were more frequent with AIT (73%) than placebo (31%), increasing with dose level. AIT TRAEs were mostly mild (94%) or moderate (5%). No serious TRAEs or anaphylactic shock occurred. The most common TRAEs with AIT were localized pruritus, nasal irritation, and throat irritation. Median onset for common AIT application site reactions was ≤24 hours after first treatment (median duration, 15-50 minutes). AIT increased immunoglobulin (Ig) significantly more than placebo (ragweed-specific IgE [6, 12, and 24 Amb a 1-U]; IgG4 [all doses]; p < 0.05). Three subjects in dose groups ≥24 Amb a 1-U experienced symptoms suggestive of systemic reaction. Of tested doses, ragweed AIT <24 Amb a 1-U once-daily was well tolerated in subjects with ragweed-induced ARC. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/ NCT01134705. Copyright © 2012, OceanSide Publications, Inc., U.S.A. Source


Purpose of the study. To evaluate, in real life settings, the clinical profile and management of polysensitized patients according to the nature of allergens involved. Patients and methods: Observational, prospective, multicentre, cross-sectional study conducted in France in patients older than 5 years, polysensitised and having a respiratory allergy. Sociodemographic data, history of allergy and the therapeutic approach considered were collected from September 2010 to January 2011. Results: Of the 2434 polysensitized patients, included by 287 qualified doctors in allergy, 70.2% were polyallergic. Mite allergens were the most involved (77%) then grass pollen (75%) and animal dander (43%). The most frequent polyallergies were mites and grass pollen associations (39.7% of patients). Following the visit, a specific immunotherapy was prescribed to 84.3% of patients. Perennial sensitization increased the likelihood of introduction of sublingual immunotherapy (SLIT), while polysensitization was not a factor. The SLIT prescribed were mites extracts (53.3% of cases), grasses extracts (20.3%), and tree pollens extracts (12.6%). Patients received a single preparation (72.5%), with a single allergen for 86% of them, or two preparations (26.3%) with a single allergen for 97%. Conclusion: Polysensitisation with polyallergy is a common feature of patients who visit. The prescription of immunotherapy was adapted to the complex profile of these patients. Desensitization was directed primarily against mites. © 2012. Source


Senna G.E.,Unita Operativa di Allergologia Ospedale Civile Maggiore di Verona | Calderon M.,Imperial College London | Milani M.,ALK Abello
Expert Review of Clinical Immunology | Year: 2011

Immunotherapy is the only treatment for allergy that alters the natural course of this disease. Sublingual immunotherapy has been developed to make immunotherapy more suitable for allergic patients. In the largest clinical program ever conducted with grass allergen-specific immunotherapy, over 2000 adults and more than 500 children have been exposed to Grazax® (ALK-Abello A/S, Hoersholm, Denmark). Grazax is an oral lyophilisate tablet (allergy immunotherapy tablet [AIT]) for sublingual administration, containing 75,000 standardized quality tablet units of allergen extract of grass pollen (Phleum pratense). Grazax is indicated for treatment of grass pollen-induced rhinitis and conjunctivitis in adult and pediatric patients. Results from the GT-08 trial (first, second and third treatment years) showed a reduction of 31, 36 and 29%, respectively, in symptom scores and a reduction of 38, 45 and 40% of medication scores, respectively, compared with placebo. Subjects treated with Grazax also had an increased number of well days and a relevant improvement in quality of life. More subjects experienced excellent and complete rhinoconjunctivitis control in comparison with patients treated with symptomatic medications only. Grazax treatment is also associated with a sustained and relevant increase of specific IgG4. This increase is also observed after stopping AIT treatment. The most common adverse events related to Grazax treatment are local reactions, such as oral itch, edema of the mouth, ear pruritus, throat irritation and sneezing. Clinical efficacy of Grazax is observed also after 1 and 2 years of follow-up after stopping the AIT treatment. Grazax is efficacious and safe for treatment of grass-pollen rhinoconjunctivitis in both adults and children. Grazax is the first AIT showing a disease-modifying effect on grass pollen-induced allergic rhinoconjuctivitis. © 2011 Expert Reviews Ltd. Source


Asero R.,Ambulatorio di Allergologia | Jimeno L.,ALK Abello | Barber D.,ALK Abello
Journal of Investigational Allergology and Clinical Immunology | Year: 2010

Background: Calcium-binding proteins (polcalcins) and profilin are cross-reacting panallergens that sensitize a minority of pollen-allergic patients. Their clinical relevance remains controversial. Objective: To assess the clinical relevance of hypersensitivity to polcalcin and profilin detected by skin prick test (SPT) in a large group of pollen-allergic patients. Methods: Two hundred pollen-allergic adults (101 men, 99 women; mean age 34 years) underwent SPT with 9 pollens present in the geographical area of the study. Hypersensitivity to panallergens was detected by SPT with date palm polcalcin and profilin. Allergy to birch and/or cypress, grass and/or pellitory, and ragweed and/or mugwort were associated with 3 symptomatic periods, respectively, late February to mid-May, late April to mid-July, and mid-August to late September. Results: Sixteen (8%) patients reacted to date palm polcalcin; 7/7 (100%) corecognized the grass polcalcin Phl p 7 in vitro. Clinically, only 4 (25%) had symptoms in all 3 seasonal periods. Forty (20%) patients reacted to profilin; only 32 (80%) reacted to cypress, and 22 (55%) to pellitory. Only 4 (10%) patients had symptoms during all 3 seasonal periods. Six patients (3%) were cosensitized to both polcalcin and profilin. Conclusions: The clinical relevance of hypersensitivity to pollen panallergens is often limited; many allergic patients have symptoms only during the central period, suggesting primary grass sensitization. Profilin-allergic patients often do not corecognize pellitory and cypress pollen. In vivo component-resolved diagnosis of seasonal respiratory allergies is a promising approach that might lead to cost reduction and a faster definition of pollen-allergic cases. © 2010 Esmon Publicidad. Source

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