Safety of specific immunotherapy using a depigmented and polymerised extract of Dermatophagoides pteronyssinus in children under five years of age

Hernández, Nora; Ibero, M; Ridao, Marina; Artigas, Rocío; Viñas, Marta; Castillo, Miriam

doi:10.1016/j.aller.2010.09.002

Cited by 7 publications

(8 citation statements)

References 13 publications

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“…Finally, it is difficult to exactly define the allergen concentration of an extract, and it can significantly vary between different manufacturers or even between different batches from the same manufacturer (personal communication with Stallergenes). These factors may contribute to the lower rate of AEs reported by Hernandez et al [13] than in our study. It therefore appears difficult to compare the rate of AEs between studies using different cluster regimens with different allergen extracts.…”

Section: Adverse Events During Cluster Regimencontrasting

confidence: 45%

“…Cluster and even rush regimens have been introduced into clinical routine for hymenoptera venom SCIT [6], but are less commonly used for aeroallergens such as house dust mites (HDM) [2] despite a safety profile comparable to conventional SCIT [3,7,8]. Cluster regimens for HDM SCIT have mainly been investigated in adult or mixed adult and pediatric study populations [3,[8][9][10][11][12], while data on pediatric populations are rarer [7,13,14]. We therefore carried out this study to assess the safety and tolerability of a cluster regimen for HDM SCIT in a pediatric population, to assess its applicability in the clinical routine of a pediatric hospital, and to identify risk factors for the development of AEs during the cluster regimen.…”

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confidence: 99%

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Fast Updosing of Subcutaneous House Dust Mite Immunotherapy is Well Tolerated by Pediatric Patients

Köhli¹

2016

Int J Immunol Immunother

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Data on the safety of a cluster regimen to start a subcutaneous immunotherapy (SCIT) with house dust mite (HDM) extract in pediatric patients are scarce. This study investigates the rate of adverse events (AEs) and the applicability of a cluster regimen for HDM SCIT in pediatric patients, and identifies possible risk factors for the development of AEs. A total of 147 injections with a depot extract (D. pteronyssinus / D. farinae, 50% each) were applied to 21 HDM-sensitized pediatric patients (age 5-18 years) with allergic asthma and/or allergic rhinitis within 2 weeks. All patients completed the cluster regimen with the full cummulative dose. Systemic adverse events (AEs) were mild to moderate (rhinitis, nausea or mild asthma), and occurred after 5 injections (3.4%) in three different patients (14.3%). Local AEs occurred in 14 patients (66.7%); 11 patients had minor local AEs and only 3 patients had major local AEs of a diameter ≥ 5 cm. All AEs developed within 60 minutes after the last injection. Patients with local AEs had higher total IgE serum levels than patients without AEs (p = 0.02). In conclusion, the cluster regimen for induction of HDM SCIT is a safe and well tolerated procedure in children.

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Section: Adverse Events During Cluster Regimencontrasting

confidence: 45%

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confidence: 99%

Fast Updosing of Subcutaneous House Dust Mite Immunotherapy is Well Tolerated by Pediatric Patients

Köhli¹

2016

Int J Immunol Immunother

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“…The glutaraldehyde-polymerized depigmented allergen extracts show a significant decrease in specific IgE binding capacity, being more immunogenic and less allergenic, thus allowing the treatment to be initiated with higher doses, compared to the unmodified extracts, and a maintenance dose to be reached in a short period of time, potentiating the earlier onset of efficacy [ 16 ]. Several studies have shown the safety and early clinical efficacy of SCIT, using vaccines containing modified allergen extracts (depigmented and polymerized) in children and adults with allergic rhinoconjunctivitis and/or asthma with mite- and/or pollen-sensitization, most of them using conventional or cluster schedules [ 9 17 18 19 20 21 22 23 24 25 ].…”

Section: Discussionmentioning

confidence: 99%

Ultrarush schedule of subcutaneous immunotherapy with modified allergen extracts is safe in paediatric age

Morais‐Almeida

Arêde

Sampaio

et al. 2016

Asia Pacific Allergy

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BackgroundTraditional subcutaneous immunotherapy up dosing with allergenic extracts has been shown to be associated with frequent adverse reactions. In recent studies it has been demonstrated that using modified extracts, namely allergoids, it is a safe and effective procedure particularly on accelerated schedules. However data assessing its safety in paediatric age is scarce.ObjectiveTo evaluate the safety profile in paediatric population of using modified allergen extracts, in an ultrarush schedule, to reach the maintenance dose in the first day.MethodsWe included children undergoing treatment with subcutaneous immunotherapy during a five-year period, using modified aeroallergen extracts, depigmented, polymerized with glutaraldehyde and adsorbed on aluminium hydroxide using an ultrarush induction phase. The type of adverse reactions during the ultrarush protocol was recorded.ResultsWe studied 100 paediatric patients (57 males) with a mean age of 11.6 years (5 to 18 years; standard deviation, 3.3), all with moderate to severe persistent rhinitis, with or without allergic conjunctivitis, asthma and atopic eczema, sensitized to mites and/or pollens. All reached the maintenance dose of 0.5 mL in the first day, except 1 child. During the ultrarush protocol the total number of injections was 199. There were 21 local adverse reactions in 11 patients, 11 immediate and 10 delayed; from those, had clinical relevance 1 immediate and 4 delayed. Systemic reactions were recorded in 2 cases, both immediate and mild.ConclusionThe ultrarush protocol, without premedication, was a safe alternative to be used in paediatric age during the induction phase of subcutaneous immunotherapy using allergoid depigmented extracts.

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“…The remaining 24 full-text articles were reviewed for more detailed evaluation; 15 of them were also excluded. Of them, 4 studies were not real randomized/controlled studies [13]–[16], 10 studies in which some patients included were asthmatics alone without AR [17]–[26], and 1 study did not perform a real cluster protocol [27]. Additional, a RCT was excluded due to repeated data [28].…”

Section: Resultsmentioning

confidence: 99%

Cluster Subcutaneous Allergen Specific Immunotherapy for the Treatment of Allergic Rhinitis: A Systematic Review and Meta-Analysis

Feng

Xü

et al. 2014

PLoS ONE

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BackgroundAlthough allergen specific immunotherapy (SIT) represents the only immune- modifying and curative option available for patients with allergic rhinitis (AR), the optimal schedule for specific subcutaneous immunotherapy (SCIT) is still unknown. The objective of this study is to systematically assess the efficacy and safety of cluster SCIT for patients with AR.MethodsBy searching PubMed, EMBASE and the Cochrane clinical trials database from 1980 through May 10th, 2013, we collected and analyzed the randomized controlled trials (RCTs) of cluster SCIT to assess its efficacy and safety.ResultsEight trials involving 567 participants were included in this systematic review. Our meta-analysis showed that cluster SCIT have similar effect in reduction of both rhinitis symptoms and the requirement for anti-allergic medication compared with conventional SCIT, but when comparing cluster SCIT with placebo, no statistic significance were found in reduction of symptom scores or medication scores. Some caution is required in this interpretation as there was significant heterogeneity between studies. Data relating to Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in 3 included studies were analyzed, which consistently point to the efficacy of cluster SCIT in improving quality of life compared to placebo. To assess the safety of cluster SCIT, meta-analysis showed that no differences existed in the incidence of either local adverse reaction or systemic adverse reaction between the cluster group and control group.ConclusionBased on the current limited evidence, we still could not conclude affirmatively that cluster SCIT was a safe and efficacious option for the treatment of AR patients. Further large-scale, well-designed RCTs on this topic are still needed.

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Safety of specific immunotherapy using a depigmented and polymerised extract of Dermatophagoides pteronyssinus in children under five years of age

Abstract: Specific immunotherapy in children under five years of age with the extract used is safe. We consider that further studies are needed, involving other types of extracts, to allow reconsideration of the relative contraindication of patient age for the administration of immunotherapy.

Cited by 7 publications

References 13 publications

Fast Updosing of Subcutaneous House Dust Mite Immunotherapy is Well Tolerated by Pediatric Patients

Fast Updosing of Subcutaneous House Dust Mite Immunotherapy is Well Tolerated by Pediatric Patients

Ultrarush schedule of subcutaneous immunotherapy with modified allergen extracts is safe in paediatric age

Cluster Subcutaneous Allergen Specific Immunotherapy for the Treatment of Allergic Rhinitis: A Systematic Review and Meta-Analysis

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