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Wise et al.

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• Harm: Transcutaneous immunotherapy resulted in systemic and local reactions. Systemic reactions occurred in up to 14.6% of patients receiving grass transcutaneous immunotherapy. • Cost: Unknown. • Benefits-Harm Assessment: There is limited and inconsistent data on benefit of the treatment, while there is a concerning rate of adverse effects. Three out of 4 studies on this topic were published by the same investigators from 2009 to 2015. • Value Judgments: Transcutaneous immunotherapy could offer a potential alternative to SCIT and SLIT, but further research is needed. • Policy Level: Recommend against. • Intervention: While transcutaneous immunotherapy may potentially have a future clinical application in the treatment of AR, at this juncture there are limited studies that show variable and limited effectiveness, and a significant rate of adverse reactions. Given the above and the availability of alternative treatments, transcutaneous immunotherapy is not recommended presently. IX.D.6. Intralymphatic immunotherapy (ILIT)— Intralymphatic immunotherapy (ILIT) is a novel method for AIT, where allergen is injected directly into lymph nodes. 1716 The major advantages of this route of allergen application are the markedly reduced duration of immunotherapy treatment (both time spent and number of visits) and the much lower amount of allergen required to achieve results. This lower dose of allergen also confers a lower risk of adverse allergic side effects. Clinical trials have illustrated that a reduction in AR symptoms can be achieved with just 3 doses of injected allergen, with a dosage interval of 1 month 1716-1720 (Table IX.D.6). This contrasts with subcutaneous application, where up to 70 doses may be needed over a 5-year period. ILIT involves the injection of allergen directly into inguinal lymph nodes under ultrasound guidance. Five of the clinical trials published to date have compared ILIT with placebo. In 2008, Senti et al. 1716 compared ILIT to SCIT and not to placebo. All trials have used aluminum hydroxide-adsorbed antigen as the vaccine. Most trials 1716,1718-1721 used commercially available grass pollen or birch pollen allergen extract as the antigen. One trial 1717 used recombinant major cat dander allergen fused to a translocation sequence and to part of the human invariant chain generating a modular antigen transporter, or “MAT,” vaccine. The general protocol for administration was 3 injections with 1000 standardized quality units (SQ-U) of aluminum hydroxide-adsorbed allergen at 4-week intervals. Variations to this included a shorter dose interval in 1 trial 1721 and no translation of allergen quantities into SQ-U in the trial using recombinant major cat dander allergen. 1717 Of the 6 trials published thus far, 5 have demonstrated clinical efficacy and safety. 1716-1720 In total, 127 patients have received active treatment and 45 patients have received placebo.

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Int Forum Allergy Rhinol . Author manuscript; available in PMC 2020 June 10.