Reviews and feature article
Guideline recommendations on the use of allergen immunotherapy in house dust mite allergy: Time for a change?

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Guidelines on the treatment of asthma, allergic rhinitis (AR), and allergen immunotherapy (AIT) lack recommendations for house dust mite (HDM) allergy. An expert panel reviewed current guidelines in the light of new data to assess whether guidelines could be improved. Most guidelines and key position papers did not provide specific recommendations on treatment of allergic asthma (AA) caused by HDM allergy, although some included AIT as a treatment option for AA in general. Around half of the guidelines stated that AIT with HDM extract was an effective treatment for AR, with several indicating sublingual immunotherapy as an option. This heterogeneity is caused by quality issues affecting studies of AIT with perennial allergens in patients with AA and AR, including use of different diagnosis and severity criteria, lack of consistent scoring or grading systems for primary and safety outcomes, and lack of consensus on treatment parameters. There is a need for well-designed clinical trials to serve as a basis for guideline recommendations. Although results from recent studies strengthen the evidence base for the efficacy and safety of sublingual immunotherapy in patients with HDM-induced AA and AR, their effect on subsequent guideline updates will depend on the methodology and evidence model used by each guideline.

Section snippets

Specific guideline recommendations for AR

All reviewed guidelines on treatment of AR included AIT as a possible treatment for selected patients with AR (Table I).3, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 Some specified that AIT with HDM extracts was effective in both adults and children.6, 7, 8 Several guidelines included SLIT as an option for treatment of AR in adults6 or both adults and children,9, 10, 11 and some specified that SLIT with HDM allergens was effective and safe in patients with AR.3, 7, 12 The Allergic Rhinitis and its

Evidence needed to support AIT treatment recommendations for HDM allergy is emerging

The recently published outcomes of large, randomized, double-blind, placebo-controlled AIT field studies in patients with HDM-induced AA (MITRA: MT-04, EudraCT 2010-018621-19; ALK-Abelló, Hørsholm, Denmark5) and HDM-induced AR in Europe (MERIT: MT-06, EudraCT 2011-002277-38, ALK-Abelló4; VO57.07, EudraCT 2011-002277-38, Stallergenes, Antony, France38) the United States (MK-8237-001; Merck, White House Station, NJ39), and Japan (Torii Pharmaceuticals, Tokyo, Japan40) show that 3 different HDM

Could data from new, well-designed, high-quality studies provide sufficient evidence for a recommendation in guidelines?

Well-designed and well-conducted trials are a key step in obtaining regulatory approval for new treatments; however, trial populations do not always closely represent the type of patients encountered in routine care.42 More than half of asthmatic patients do not achieve control with their current pharmacotherapy, and even patients with well-controlled asthma experience, on average, 6 worsenings per year (defined as occasions when asthma symptoms were bothersome or hindering).43 Similarly, not

Conclusions

Even though AIT was first described more than a century ago and up to 50% of patients with HDM-induced AR also have AA, specific treatment recommendations for AIT in patients with AA, AR, or both caused by HDM allergy remain unclear. This has largely been due to the relatively low quality of the body of evidence supporting the use of AIT in this context, which has complicated quantification of AIT's effect. Reasons include heterogeneity in study design and reporting of outcomes, a lack of

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    Supported by ALK-Abelló.

    Disclosure of potential conflict of interest: M. Calderón has consultant arrangements with ALK-Abelló, HAL Allergy, Allergopharma, Merck, and Stallergenes Greer. J. Bousquet has received personal fees for scientific and advisory boards from Almirall, Meda, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, and Uriach and has received personal fees for lectures from Almirall, AstraZeneca, Chiesi, GlaxoSmithKline, Meda, Menarini, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, and Uriach. L.-O. Cardell has a board membership and has received grants and payment for lectures from ALK-Abelló. D. Hernandez Fernandez de Rojas is a member of an advisory board for house dust mite sublingual immunotherapy for ALK-Abelló. J. Kleine-Tebbe is a member of advisory boards for ALK-Abelló, Novartis, Leti, and Bencard; has consultant arrangements with Merck and Circassia; has received grants from Circassia, Leti, and Stallergenes Greer; and has received payment for lectures from Allergopharma, ALK-Abelló, Bencard, HAL Allergy, Leti, Lofarma, Novartis, and Stallergenes Greer. P. Demoly has received a consulting fee or honorarium from ALK-Abelló, Stallergenes Greer, Thermo Fisher Scientific, Chiesi, AstraZeneca, Meda, Menarini, and Allergopharma. G. W. Canonica declares that he has no relevant conflicts of interest.

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