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  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 1

    EAACI Guidelines on Allergen Immunotherapy: allergic rhinoconjunctivitis 1

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    Draft 1.0; 12th May 2017 3

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    Short title: EAACI Rhinoconjunctivitis Allergen Immunotherapy Guidelines 6

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    Key words: allergen immunotherapy, allergy, allergic conjunctivitis, allergic rhinitis, 8

    rhinoconjunctivitis 9

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    Abbreviations: 11

    AR, allergic rhinoconjunctivitis; AIT, allergen immunotherapy; AGREE II, Appraisal of 12

    Guidelines for Research & Evaluation; ARIA, Allergic Rhinitis and it Impact on Asthma; EPIT, 13

    epicutaneous immunotherapy; EAACI, European Academy of Allergy and Clinical 14

    Immunology; EMA, European Medicines Agency; HDM, house dust mite; ICER, incremental 15

    cost-effectiveness ratio; NARES, non-allergic rhinitis with eosinophilia syndrome; QALY, 16

    quality-adjusted life years; RCT, randomized controlled trial; SPT, skin prick test; SMD, 17

    standardized mean difference; SCIT, subcutaneous immunotherapy; SLIT, sublingual 18

    immunotherapy; SmPC, manufacturer‘s product information (SmPC), summary or product 19

    characteristics. 20

  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 2

    ABSTRACT 1

    Allergic rhinoconjunctivitis (AR) is an allergic disorder affecting the nose and eyes with a 2

    prevalence of about 20% of the general population. Symptoms are frequently controlled with 3

    avoidance measures and pharmacotherapy. However, many patients continue to have 4

    ongoing symptoms and impaired quality of life. Allergen immunotherapy (AIT) represents an 5

    important additional therapeutic option. These Guidelines have been prepared by the 6

    European Academy of Allergy and Clinical Immunology’s (EAACI) Taskforce on AIT for AR 7

    and are part of the EAACI presidential project ‘AIT Guidelines’. They aim to provide evidence-8

    based clinical recommendations and have been informed by a formal systematic review and 9

    meta-analysis. Their generation has followed the Appraisal of Guidelines for Research and 10

    Evaluation (AGREE II) approach. The process included representation of the full range of 11

    stakeholders. Key sections cover ‘general considerations before initiating AIT for AR’, ‘allergen 12

    immunotherapy for AR: evidence-based, clinical recommendations’, ‘other approaches for 13

    AIT’, ‘allergen factors that may affect the efficacy of AIT for AR’, ’patient factors that may affect 14

    the efficacy of AIT for AR’, ‘how long should AIT be continued for in AR’, ‘adverse events with 15

    ASIT for AR’, ‘preventive effects of AIT for AR’, ‘pharmacoeconomic aspects of AIT versus 16

    pharmacotherapy for AR’ and ‘summary, gaps in the evidence and future perspectives’. In 17

    general, broad evidence for the clinical efficacy of AIT exists but a product-specific evaluation 18

    of evidence is recommended. 19

    20

  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 3

    SECTION A: INTRODUCTION 1

    Allergic rhinoconjunctivitis (AR) is an allergic disorder affecting the nose and eyes, resulting 2

    in chronic, mostly eosinophilic, inflammation of the nasal mucosa and conjunctiva [Eifan 2016; 3

    Greiner 2011]. Allergic rhinitis, with or without conjunctivitis, is one of the most prevalent 4

    allergic diseases affecting around a fifth of the general population [Singh 2010; Meltzer 2009; 5

    Ait-Khaled 2009]. It is associated with considerable loss of productivity and impaired school 6

    performance [Walker 2007]. 7

    AR can usually be diagnosed from its typical presentation (Figure A). Symptoms include 8

    itching, sneezing, watery nasal discharge often nasal congestion [Roberts 2013]. There is 9

    often associated eye symptoms (watery, red and/or itchy eyes). Symptoms may be described 10

    as seasonal and/or perennial; as intermittent or persistent; or mild, moderate or severe 11

    according to its impact on quality of life (Bousquet 2008). Symptoms are related to exposure 12

    to the offending allergen as well as to non-specific triggers such as smoke, dust, viral 13

    infections, strong odors and cold air [Roberts 2013]. Evidence of allergen-specific IgE 14

    sensitization to one or more aeroallergens suggested by the history supports the diagnosis. 15

    AR may co-exist with other forms of rhinitis (Figure A). Additionally, AR may be associated 16

    with sinusitis symptoms, auditory dysfunction and asthma [Roberts 2013]. 17

    The aims of AR management are to control symptoms and reduce inflammation. Where 18

    possible, allergen avoidance can be recommended although effective allergen avoidance is 19

    not always feasible [Terreehorst 2003; Sheikh A Cochrane review 2010]. Many patients rely 20

    on pharmacotherapy with e.g., oral or topical antihistamines, intranasal corticosteroids, topical 21

    cromoglycate or leukotriene receptor antagonists [Roberts 2013]. However, these therapies 22

    do not alter the natural history of AR. Additionally, despite medication, a significant number of 23

    patients continue to experience symptoms that impair their quality of life. Allergen 24

    immunotherapy (AIT) that involves regular subcutaneous (SCIT) or sublingual (SLIT) 25

    administration of the culprit allergen(s) may not only desensitize a patient thereby ameliorating 26

    symptoms but also modify the underlying natural history of the disease [Pfaar 2014; Jutel 27

    2015; Jutel 2016]. 28

    These Guidelines have been prepared by the European Academy of Allergy and Clinical 29

    Immunology’s (EAACI) Taskforce on Allergen Immunotherapy (AIT) for Rhinoconjunctivitis 30

    and are part of the EAACI AIT Guidelines. These Guidelines aim to provide evidence-based 31

    recommendations for the use of AIT for patients with allergic rhinitis with or without 32

    conjunctivitis. AR will be used to signify either allergic rhinitis or allergic rhinoconjunctivitis. 33

    The primary audience are clinical allergists, although the guidelines are of relevance to other 34

    healthcare professionals (e.g. primary care workers, other specialist doctors, nurses and 35

  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 4

    pharmacists working across a range of clinical settings) dealing with AR. The development of 1

    the Guidelines has been informed by a formal systematic review and meta-analysis of AIT for 2

    AR [Dhami 2017], with systematic review principles being used to identify additional evidence, 3

    where necessary. 4

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    6 7

    Figure A. Differential diagnosis of allergic rhinoconjunctivitis 8

    Adapted from Roberts 2013. Local allergic rhinitis may be seen where there is only evidence 9

    of local nasal allergic sensitization [Campo 2015; Carmen 2010]. There are numerous other 10

    causes of non-allergic, non-infectious rhinitis, examples are non-allergic rhinitis with 11

    eosinophilia syndrome (NARES) and gastro-oesophageal reflux [Roberts 2013]. In individual 12

    patients, symptoms may be driven by more than one trigger. Rhinosinusitis is not included in 13

    the scope of these Guidelines. 14

  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 5

    Box 1. Key terms

    Rhinitis Inflammation of the nasal epithelium resulting in at least two nasal

    symptoms: rhinorrhea, blockage, sneezing or itching.

    Conjunctivitis Inflammation of the conjunctiva characterized by watery, itchy, red

    eyes.

    Sensitization Detectable allergen specific IgE antibodies, either by means of skin

    prick test (SPT) or specific IgE antibodies in a blood sample

    Allergen

    immunotherapy (AIT) Repeated allergen administration at regular intervals to modulate

    immune response in order to reduce symptoms and the need of

    medication for clinical allergies and to prevent the development of new

    allergies and asthma (adapted from European Medicines Agency

    (EMA)). This is also sometimes known as allergen specific

    immunotherapy, desensitization and hypo-sensitization

    Subcutaneous

    immunotherapy (SCIT) Form of allergen immunotherapy where the allergen is administered as

    a series of subcutaneous injections.

    Sublingual

    immunotherapy (SLIT) Form of allergen immunotherapy where the allergen is administered

    under the tongue.

    Short-term efficacy Clinical benefit to the patient while they are receiving AIT

    Long-term efficacy Clinical benefit to the patient for at least one year after cessation of the

    AIT course. This implies that the AIT has altered the natural history of

    the patient’s allergic disease.

    1

  • Rhinoconjunctivitis AIT guideline – draft Draft 1.0; 12th May 2017 6

    SECTION B: METHODOLOGY 1

    These Guidelines were produced using the Appraisal of Guidelines for Research & Evaluation 2

    (AGREE II) approach [Agree Collaboration 2003; Brouwers 201