Safety of a rush immunotherapy build-up schedule with depigmented polymerized allergen extracts

Klimek, Ludger; Pfaar, Oliver; Hauswald, B.; Worm, Margitta; Bieber, Thomas

doi:10.2500/aap.2010.31.3334

Cited by 23 publications

(24 citation statements)

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“…For both Depigoid ® D. pteronyssinus and Depigoid ® HDM mixture , two recommended treatment regimen according to the Summary of Product Characteristics (SmPC) exist: (1) a 4‐week build‐up regimen with escalating doses (2, 5, 20, and 50 DPP) administered at weekly intervals followed by a maintenance regimen with administration of 50 DPP every 4 weeks. (2) Alternatively, a quick build‐up dosing regimen (day 1: 20 and 30 DPP with a 30‐min interval; further dosages of 50 DPP to be applied in 4 week intervals).…”

Section: Methodsmentioning

confidence: 99%

House dust mite-specific immunotherapy with two licensed vaccines: Outcome under clinical routine conditions

Mahler

Klein

Sager

et al. 2017

Immunity, Inflammation and Disease

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IntroductionHouse dust mite (HDM) allergens are major causes for the development of allergic diseases. A disease modifying effect and clinical benefit of allergen immunotherapy (AIT) has been demonstrated in a number of clinical trials. Clinical trials, however, are carried out in selected populations under specific conditions based on inclusion and exclusion criteria and may not represent the entire patient population from medical practice. Objective of this study conducted in patients with HDM allergy was to systematically collect information about the benefit of AIT under clinical routine conditions.MethodsIn this prospective, multi‐center non‐interventional study, 220 patients (117 adults, 103 children) with HDM allergy receiving subcutaneous AIT with Depigoid® were monitored for 2 years. Organ‐specific key symptoms, health‐related quality of life (QoL), and the use of concomitant anti‐allergic medication were assessed at baseline and after 12 and 24 months. Effectiveness and tolerability of the AIT was assessed by physicians and patients. Occurrence of adverse events (AEs) was continuously monitored.ResultsTwo hundred and nineteen patients (116 adults, 103 children) were evaluated. A major improvement of the total symptom‐score was observed after 24 (12) months in 76% (72%) and 80% (79%) of adults and children, respectively, accompanied by a reduction in concomitant anti‐allergic medication and a pronounced improvement in QoL. The effectiveness and tolerability of the AIT was estimated as very good/good by 80–90% of physicians and patients. AEs were observed in 4/117 adults (3.4%) and in 7/103 children (6.8%). Serious AEs were reported in three adults and one child: A grade‐II anaphylactic reaction (one adult) controlled by oral antihistamines (no hospitalization) classified as “definitely,” three others as not (2) or possibly (1) drug‐related.ConclusionsThe data collected from 220 patients confirm the efficacy, tolerability/safety, and acceptance of AIT with Depigoid® in adults and children with HDM allergy under routine clinical conditions.

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Section: Methodsmentioning

confidence: 99%

House dust mite-specific immunotherapy with two licensed vaccines: Outcome under clinical routine conditions

Mahler

Klein

Sager

et al. 2017

Immunity, Inflammation and Disease

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“…187,188 Also, studies indicate that modified allergen extracts are associated with less adverse effects. [189][190][191][192] For aluminum hydroxide containing SCIT products, granulomas have been described from a foreign body reaction mainly caused by incorrect intradermal administration as well as contact allergic reactions, new onset of protein contact dermatitis, or a vasculitis inflammatory reactions have been reported. [193][194][195] If these reactions to SCIT occur, treatment with another aluminum hydroxide-free product is preferred (Grade D).…”

Section: Scitmentioning

confidence: 99%

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Roberts

Pfaar

Akdiş

et al. 2017

Allergy

564

705

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drawn on data from a systematic review of the literature, more recent published studies and multistakeholder expert clinical opinion. This Guideline is aimed at healthcare professionals who are encouraged to take the recommendations into account in the context of delivering clinical care. This Guideline is not a substitute for professional clinical judgment, which professionals need to exercise in the context of delivering personalised healthcare. AbstractAllergic rhinoconjunctivitis (AR) is an allergic disorder of the nose and eyes affecting about a fifth of the general population. Symptoms of AR can be controlled with allergen avoidance measures and pharmacotherapy. However, many patients continue to have ongoing symptoms and an impaired quality of life; pharmacotherapy may also induce some side-effects. Allergen immunotherapy (AIT) represents the only currently available treatment that targets the underlying pathophysiology, and it may have a disease-modifying effect. Either the subcutaneous (SCIT) or sublingual (SLIT) routes may be used. This Guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Taskforce on AIT for AR and is part of the EAACI presidential project "EAACI Guidelines on Allergen Immunotherapy." It aims to provide evidence-based clinical recommendations and has been informed by a formal systematic review and meta-analysis. Its generation has followed the Appraisal of Guidelines for Research and Evaluation (AGREE II) approach.The process included involvement of the full range of stakeholders. In general, broad evidence for the clinical efficacy of AIT for AR exists but a product-specific evaluation of evidence is recommended. In general, SCIT and SLIT are recommended for both seasonal and perennial AR for its short-term benefit. The strongest evidence for long-term benefit is documented for grass AIT (especially for the grass 766 | ROBERTS, PFAAR ET AL. tablets) where long-term benefit is seen. To achieve long-term efficacy, it is recommended that a minimum of 3 years of therapy is used. Many gaps in the evidence base exist, particularly around long-term benefit and use in children. | ME TH ODOLOGYThis Guideline was produced using the Appraisal of Guidelines forResearch & Evaluation (AGREE II) approach, 17,18 a structured approach to guideline production (see Table S1). This is designed to ensure appropriate representation of the full range of stakeholders, a careful search for and critical appraisal of the relevant literature, a systematic approach to the formulation and presentation of recommendations and steps to ensure that the risk of bias is minimized at each step of the process. The process started on April 2015 beginning with detailed face-to-face discussions agreeing on the process and the key clinical areas to address, followed by face-to-face meetings, and regular web conferences in which professional and lay representatives participated. | Clarifying the scope and purpose of the guidelinesThe scope of this EAACI Guideline is multifaceted...

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“…Polymerized and depot extracts seem to allow a lower number of clusters and of doses per cluster, decreasing the risk of severe adverse events [68,69] (TABLE 4).…”

Section: Allergen Compositionmentioning

confidence: 99%

Incidence and risk factors for subcutaneous immunotherapy anaphylaxis: the optimization of safety

Caminati

Dama

Djuric

et al. 2014

Expert Review of Clinical Immunology

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Fatal reactions related to subcutaneous allergen immunotherapy are rare: one event in 2.5 million injections has been reported in the USA and none in Europe. The prevalence of very severe systemic reactions (systemic adverse events [SAEs]) is one in 1 million injections. Though the serious events rate is decreasing and the majority of SAEs (∼0.2% per injection) are moderate and reversible, they still represent a major concern. Uncontrolled asthma, long-term therapy with β-blockers and high degree of allergen sensitivity are generally considered risk factors. The relevance of other conditions, like previous local reactions, the use of extracts conjugated with adjuvants and accelerated build-up schedules is controversial, as well as the role of preventative strategies. A careful risk assessment of patients and optimal administration procedures may significantly decrease the risk of SAEs. However, more uniform safety data are required and an accurate safety profile should be provided for every allergen product.

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Safety of a rush immunotherapy build-up schedule with depigmented polymerized allergen extracts

Cited by 23 publications

References 0 publications

House dust mite-specific immunotherapy with two licensed vaccines: Outcome under clinical routine conditions

House dust mite-specific immunotherapy with two licensed vaccines: Outcome under clinical routine conditions

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Incidence and risk factors for subcutaneous immunotherapy anaphylaxis: the optimization of safety

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