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  1. Article: Sublingual immunotherapy: efficacy--methodology and outcome of clinical trials.

    Malling, H-J

    Allergy

    2006  Volume 61 Suppl 81, Page(s) 24–28

    Abstract: Using Medline we identified 39 placebo-controlled, double-blind sublingual immunotherapy (SLIT) studies providing symptom-medication score. These were retrospectively evaluated for evidence of clinical efficacy and quality of study presentation. Clinical ...

    Abstract Using Medline we identified 39 placebo-controlled, double-blind sublingual immunotherapy (SLIT) studies providing symptom-medication score. These were retrospectively evaluated for evidence of clinical efficacy and quality of study presentation. Clinical efficacy was estimated according to statistical significance and graded as: unequivocal efficacy (statistically significant difference from placebo in both symptom and medication scores or the combined score), which was observed in 28% of studies, possible efficacy (significant improvement in either symptom or medication scores) seen in 33%, and no efficacy (no statistical difference between active treatment and the placebo group), as found in 38% of studies. Generally, studies were limited by the number of patients, showed a high frequency of withdrawals, a short duration of treatment, and insufficient data on randomization. The magnitude of efficacy additional to placebo treatment must be >20% in order to justify the treatment. This review concludes that future SLIT studies should be planned in accordance with international recommendations in order to be conclusive.
    MeSH term(s) Administration, Sublingual ; Allergens/administration & dosage ; Clinical Trials as Topic/methods ; Desensitization, Immunologic ; Emergency Treatment ; Humans ; Meta-Analysis as Topic ; Randomized Controlled Trials as Topic/methods
    Chemical Substances Allergens
    Language English
    Publishing date 2006
    Publishing country Denmark
    Document type Journal Article ; Review
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/j.1398-9995.2006.01158.x
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  2. Article ; Online: The current state of recombinant allergens for immunotherapy.

    Pauli, Gabrielle / Malling, H-J

    Current opinion in allergy and clinical immunology

    2010  Volume 10, Issue 6, Page(s) 575–581

    Abstract: Purpose of review: Subcutaneous immunotherapy is a well documented treatment of allergic rhinitis and asthma. The majority of the disadvantages of the treatment are related to the poor quality of the natural allergen extracts which can contain varying ... ...

    Abstract Purpose of review: Subcutaneous immunotherapy is a well documented treatment of allergic rhinitis and asthma. The majority of the disadvantages of the treatment are related to the poor quality of the natural allergen extracts which can contain varying amounts of individual allergens including allergens to which the patient may not be sensitized. Recombinant allergens offer a possibility to use well defined molecules with consistent pharmaceutical quality defined in mass units. The proof of concept of the clinical efficacy of recombinant allergens is based on two studies published as full articles.
    Recent findings: One study applied a mixture of five Phleum pratense major allergens in a maximum dose of 40mcg protein. The clinical efficacy showed a significant efficacy with 40% reduction in disease severity. The second study compared a commercial birch extract with both recombinant Bet v 1 and purified Bet v 1 in dosages of 15mcg allergen. The clinical effect was 60% additional efficacy. Systemic side effects occurred more frequently with grass allergens. A third study used hypoallergenic fragments and a trimer of Bet v 1. The study did not show efficacy and a rather high frequency of systemic side effects.
    Summary: The advantages of using recombinant allergens for immunotherapy are obvious but more studies on a large scale are needed before the overall value in terms of efficacy and safety can be assessed. Clinical trials are also necessary for new combined vaccines based on recombinant allergens that in experimental studies have shown greatly enhanced immunogenicity and low allergen-specific reactivity.
    MeSH term(s) Allergens/immunology ; Allergens/therapeutic use ; Animals ; Antigens, Plant/immunology ; Antigens, Plant/therapeutic use ; Betula/immunology ; Clinical Trials as Topic ; Desensitization, Immunologic/methods ; Desensitization, Immunologic/trends ; Disease Progression ; Humans ; Hypersensitivity/drug therapy ; Hypersensitivity/immunology ; Phleum/immunology ; Recombinant Proteins/immunology ; Recombinant Proteins/therapeutic use
    Chemical Substances Allergens ; Antigens, Plant ; Recombinant Proteins
    Language English
    Publishing date 2010-12
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2088710-3
    ISSN 1473-6322 ; 1528-4050
    ISSN (online) 1473-6322
    ISSN 1528-4050
    DOI 10.1097/ACI.0b013e32833fd6c5
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  3. Article: Allergen-specific immunotherapy in allergic rhinitis.

    Malling, H J

    Current opinion in allergy and clinical immunology

    2002  Volume 1, Issue 1, Page(s) 43–46

    Abstract: The scope of this review is to highlight important and interesting articles in the field of allergen-specific immunotherapy in allergic rhinitis published within the past year. The review is not intended to give a full overview of published literature ... ...

    Abstract The scope of this review is to highlight important and interesting articles in the field of allergen-specific immunotherapy in allergic rhinitis published within the past year. The review is not intended to give a full overview of published literature but rather to focus on some subjects that I find significant in relation to the understanding of the specific treatment of allergies and to the selection of different treatment modalities. The most important aspects are how to define the most suitable candidates for the specific treatment, the mechanisms of action of immunotherapy and how to optimize treatment, and finally I include some reflections on the optimal presentation of the allergen to the immune system.
    MeSH term(s) Allergens/immunology ; Humans ; Immunotherapy ; Rhinitis, Allergic, Perennial/therapy ; Rhinitis, Allergic, Seasonal/therapy
    Chemical Substances Allergens
    Language English
    Publishing date 2002-04-19
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2088710-3
    ISSN 1528-4050
    ISSN 1528-4050
    DOI 10.1097/01.all.0000010983.53424.26
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  4. Article: Bacterial vaccines: anything but placebo.

    Malling, H J

    Allergy

    2000  Volume 55, Issue 3, Page(s) 214–218

    MeSH term(s) Animals ; Asthma/etiology ; Asthma/prevention & control ; Bacterial Infections/complications ; Bacterial Infections/prevention & control ; Bacterial Vaccines ; Humans ; Respiratory Tract Infections/complications ; Respiratory Tract Infections/prevention & control
    Chemical Substances Bacterial Vaccines
    Language English
    Publishing date 2000-03
    Publishing country Denmark
    Document type Journal Article ; Review
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1034/j.1398-9995.2000.00110.x
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  5. Article: Minimising the risks of allergen-specific injection immunotherapy.

    Malling, H J

    Drug safety

    2000  Volume 23, Issue 4, Page(s) 323–332

    Abstract: The clinical advantages of allergen-specific immunotherapy are counterbalanced by the risk of inducing systemic adverse effects. Although the frequency of life-threatening systemic reactions is low, the treatment carries a risk of inducing anaphylactic ... ...

    Abstract The clinical advantages of allergen-specific immunotherapy are counterbalanced by the risk of inducing systemic adverse effects. Although the frequency of life-threatening systemic reactions is low, the treatment carries a risk of inducing anaphylactic reactions. A fundamental point in risk assessment is to use a clinically meaningful and internationally accepted grading system for reactions. Of importance in minimising the risk of systemic adverse effects is the identification of at-risk patients and factors, the institution of procedures for monitoring patients before injections, and the adjustment of dosages in accordance with defined rules. Asthma, especially uncontrolled asthma, is a significant risk factor for the induction of systemic reactions. Likewise, dose escalation during allergen exposure, i.e. during pollen seasons, increases the risk of adverse effects. It is recommended that standardised extracts with a documented potency and consistency between production batches are used in order to prevent overdose when changing to a new vial. The intensity of the induction regimen is a balance between the risk of inducing systemic reactions and the time required to administer the regimen. Single injections once a week are generally well tolerated, in contrast to rush immunotherapy which may carry an increased frequency of adverse effects. A clustered induction regimen (2 to 4 injections per visit) represents a compromise of a patient-friendly fast regimen without an unacceptably high frequency of systemic reactions. A major issue in improving the safety of allergen injections is minimising the human factor, e.g. mistakes of patient identification, allergen extracts and dosages. Meticulous care in monitoring every patient before the injection, which requires education and training of the staff in the dosage decision process, is the cornerstone in reducing adverse effects. Involving the patient actively in the safety monitoring process might be helpful and improves patient compliance by allowing the patient to be an active partner in the treatment. Finally, if anaphylactic reactions are induced, a successful outcome is related to the staff being able to identify the early signs and to institute immediate rescue treatment. A quality assurance programme is the optimal way to minimise the risk of immunotherapy-associated systemic reactions.
    MeSH term(s) Allergens/adverse effects ; Allergens/therapeutic use ; Humans ; Immunotherapy ; Risk Assessment ; Risk Factors
    Chemical Substances Allergens
    Language English
    Publishing date 2000-10
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.2165/00002018-200023040-00005
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  6. Article ; Online: Dynamics of plasma levels of specific IgE in chlorhexidine allergic patients with and without accidental re-exposure.

    Opstrup, M S / Poulsen, L K / Malling, H J / Jensen, B M / Garvey, L H

    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

    2016  Volume 46, Issue 8, Page(s) 1090–1098

    Abstract: Background: Chlorhexidine is an effective disinfectant, which may cause severe allergic reactions. Plasma level of specific IgE to chlorhexidine (ImmunoCAP(®) ) has high estimated sensitivity and specificity when measured within 6 months of allergic ... ...

    Abstract Background: Chlorhexidine is an effective disinfectant, which may cause severe allergic reactions. Plasma level of specific IgE to chlorhexidine (ImmunoCAP(®) ) has high estimated sensitivity and specificity when measured within 6 months of allergic reaction, but knowledge of the dynamics over longer time periods is lacking and it is unknown whether levels fall below <0.35 kUA/L in patients with previously elevated levels. It is also unclear whether re-exposure influences levels of specific IgE.
    Objective: To investigate the dynamics of specific IgE in chlorhexidine allergic patients with and without re-exposure.
    Methods: All patients diagnosed with chlorhexidine allergy in the Danish Anaesthesia Allergy Centre January 1999 to March 2015 were invited to participate. The study included blood samples from the time of reaction and time of investigation and blood samples drawn prospectively over several years.
    Results: Overall, 23 patients were included. Specific IgE within hours of reaction was available in eight patients and was >0.35 kUA/L in six of these. During allergy investigations, usually 2-4 months later, specific IgE was >0.35 kUA/L in 22 of 23 patients. In the following months/years specific IgE declined <0.35 kUA/L in 17 of 23 patients (most rapidly within 4 months). Nine re-exposures in the healthcare setting were reported by seven patients (35%). Most re-exposures caused symptoms and were followed by an increase in specific IgE. Two patients with specific IgE <0.35 kUA/L reacted upon re-exposure.
    Conclusions & clinical relevance: Time from reaction should be considered when interpreting specific IgE results. Specific IgE is >0.35 kUA/L in most patients at time of reaction but should be repeated after a few weeks/months if negative. The optimal sampling time seems to be >1 month and <4 months. A value <0.35 kUA/L neither excludes allergy nor implies loss of reactivity in previously sensitized patients. Re-exposures are common, often iatrogenic, and can cause a rebound in specific IgE.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Infective Agents, Local/adverse effects ; Antibody Specificity/immunology ; Chlorhexidine/adverse effects ; Drug Hypersensitivity/blood ; Drug Hypersensitivity/diagnosis ; Drug Hypersensitivity/immunology ; Female ; Humans ; Immunoglobulin E/blood ; Immunoglobulin E/immunology ; Male ; Middle Aged ; Time Factors ; Young Adult
    Chemical Substances Anti-Infective Agents, Local ; Immunoglobulin E (37341-29-0) ; Chlorhexidine (R4KO0DY52L)
    Language English
    Publishing date 2016-05-11
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 645204-8
    ISSN 1365-2222 ; 0954-7894 ; 0960-2178
    ISSN (online) 1365-2222
    ISSN 0954-7894 ; 0960-2178
    DOI 10.1111/cea.12743
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  7. Article: Allergenspecifik immunterapi ved behandling af asthma.

    Malling, H J

    Ugeskrift for laeger

    2000  Volume 162, Issue 4, Page(s) 477–479

    Abstract: Objectives: 1. To identify all published randomised controlled trials of allergen specific immunotherapy in asthma. 2. To estimate the overall efficacy of allergen specific immunotherapy upon asthmatic symptoms, medication requirements, lung function, ... ...

    Title translation Allergen-specific immune therapy in the treatment of asthma.
    Abstract Objectives: 1. To identify all published randomised controlled trials of allergen specific immunotherapy in asthma. 2. To estimate the overall efficacy of allergen specific immunotherapy upon asthmatic symptoms, medication requirements, lung function, nonspecific bronchial hyperreactivity (BHR) and allergen specific BHR.
    Search strategy: A search of the asthma database by the Cochrane Airways Group at St. Georges Hospital Medical School, London identified 660 nonunique citations with the keywords Immunotherapy* or Hyposensitive or Desensiti*. This database included all studies published up to 1997 with the keywords Asthma or Wheez* from the Medline, Embase and Cinahl databases, together with other studies identified by handsearching.
    Selection criteria: The review was restricted to randomised controlled trials (RCT). Only studies which focussed upon asthma were included. Allergen specific immunotherapy was defined as the subcutaneous administration of extracts of house dust mites, pollens, animal danders or moulds, chemically modified allergoids or antigen-antibody complexes. Although placebo controlled trials were methodologically stronger, studies which administered house dust or other relatively antigenically inactive preparations to the control group were also considered. Double blinded trials were preferred, but single blind and open studies were also reviewed for possible inclusion. At least one of the following clinical outcomes had to be reported: asthmatic symptoms, asthma medication requirements, lung function, nonspecific BHR or allergen specific BHR. Inclusion of studies in the review was decided by a simple majority of all three reviewers, who independently read the methods sections of papers identified by the search strategy and applied the stated criteria. Quality assessment was performed by 2 reviewers, who independently assessed the concealment of allocation.
    Data collection and analysis: The comparisons were: Allergen immunotherapy v placebo, Allergen immunotherapy v antigenically inactive control, House dust v placebo and Allergen immunotherapy v untreated control. These comparisons were performed separately for each outcome, whenever these results were reported. Outcome data were extracted and entered into RevMan 3.0.1 for statistical analysis. Categorical outcomes were analysed as odds ratios (OR) and 95% confidence intervals (95% CI) calculated by Peto's method. Continuous outcomes were analysed as standardised mean differences (SMD). Fixed effects models were used to obtain summary statistics for the overall efficacy of allergen immunotherapy and x2 tests were performed to assess heterogeneity between studies.
    Main results: Fifty four randomised controlled trials published between 1954 and 1997 satisfied the inclusion criteria. There were 25 studies reporting immunotherapy for mite allergy, 13 studies of pollen allergy, eight studies of animal dander allergy, two studies of allergy to the mould Cladosporium and six studies which attempted simultaneous immunotherapy for multiple aeroallergens. Concealment of allocation was assessed as clearly adequate in only 11 studies. The adequacy or otherwise of 40 studies could not be determined from the details published in the papers. Only three studies used a clearly inadequate method for concealment of allocation. There was a significant overall improvement in asthma symptom scores following immunotherapy (combined SMD -0.52; 95% -0.70 to -0.35). Patients randomised to immunotherapy were also significantly less likely to report a deterioration in asthma symptoms than those randomised to placebo (OR 0.27; 95% CI 0.21 to 0.35). Asthma medication requirements were significantly reduced (SMD -0.51; 95% CI -0.74 to -0.28). Patients randomized to immunotherapy were also significantly less likely to require medication than those randomised to placebo (OR 0.28; 95% CI 0.19 to 0.42). There was no overall improvement in lung function following immunotherapy and marked hete
    MeSH term(s) Asthma/immunology ; Asthma/therapy ; Desensitization, Immunologic/adverse effects ; Evidence-Based Medicine ; Guidelines as Topic ; Humans ; Meta-Analysis as Topic ; Peer Review, Research ; Randomized Controlled Trials as Topic
    Language Danish
    Publishing date 2000-01-24
    Publishing country Denmark
    Document type English Abstract ; Journal Article
    ZDB-ID 124102-3
    ISSN 1603-6824 ; 0041-5782
    ISSN (online) 1603-6824
    ISSN 0041-5782
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  8. Article: Allergen-specific immunotherapy in the management of allergic rhinitis.

    Malling, H J

    Allergy

    1999  Volume 54 Suppl 56, Page(s) 35–36

    MeSH term(s) Desensitization, Immunologic/methods ; Humans ; Rhinitis, Allergic, Perennial/immunology ; Rhinitis, Allergic, Perennial/therapy
    Language English
    Publishing date 1999
    Publishing country Denmark
    Document type Journal Article ; Review
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/j.1398-9995.1999.tb04437.x
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  9. Article: Named patient products: critical aspects.

    Malling, H J

    Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M

    1999  , Issue 93, Page(s) 67–71; discussion 73–8

    MeSH term(s) Allergens/adverse effects ; Allergens/immunology ; Calibration ; Humans ; Immunotherapy
    Chemical Substances Allergens
    Language English
    Publishing date 1999
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 565509-2
    ISSN 0936-8671 ; 0172-9454
    ISSN 0936-8671 ; 0172-9454
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  10. Article: Allergen-specific immunotherapy. Present state and directions for the future.

    Malling, H J

    Allergy

    1999  Volume 54 Suppl 50, Page(s) 30–33

    MeSH term(s) Administration, Intranasal ; Administration, Sublingual ; Administration, Topical ; Adult ; Allergens/immunology ; Allergens/isolation & purification ; Allergens/therapeutic use ; Asthma/immunology ; Asthma/therapy ; Child ; Desensitization, Immunologic/methods ; Desensitization, Immunologic/trends ; Forecasting ; Humans ; Hypersensitivity/immunology ; Hypersensitivity/therapy ; Rhinitis, Allergic, Perennial/therapy
    Chemical Substances Allergens
    Language English
    Publishing date 1999
    Publishing country Denmark
    Document type Journal Article
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/j.1398-9995.1999.tb05023.x
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