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Wise et al.

Page 137

application site was significantly higher in the treatment arm, and there were no serious adverse events.

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A second single-center, double-blind RCT treated 15 children with grass transcutaneous immunotherapy and 15 children with placebo. 1713 The adhesive patch was placed weekly from February to April 2008, and removed after 24 hours. There were no significant differences in prick tests between groups before and after treatment. Both groups had an increase in symptoms, but the treatment group had lower rhinorrhea, nasal obstruction, dyspnea, and ocular tearing. The treatment group had a significant reduction in antihistamine use ( p = 0.019). There were no systemic or local reactions. A third single-center, double-blind, placebo-controlled trial, published by the same authors enrolled 132 adults with grass pollen allergic rhinoconjunctivitis. 1714 Patients received placebo, low-dose, medium-dose, and high-dose grass extract treatment (n = 33 in each arm). Weekly for 6 weeks, starting 1 month prior to the initiation of the 2008 pollen season, patches were applied with subsequent removal after 8 hours. SPT and conjunctival provocation tests were done at baseline, and after the pollen seasons of 2008 and 2009. Ninety-three of 132 patients were included in the efficacy analysis. The primary endpoint was subjective rhinoconjunctivitis symptoms using a VAS. Five months after application of the first patch, all treatment and placebo groups improved. One year later, only the high-dose treatment group had improved compared to control ( p = 0.017); symptoms were reduced by more than 30% (2008 pollen season) and 24% (2009 pollen season) compared with placebo. There were no differences in rescue medication use, SPTs, or CPTs. Local reactions were more frequent with higher doses and improved with subsequent applications. Systemic reactions leading to discontinuation of treatment occurred in 11 patients (8.3%) within 45 minutes of patch application; reactions were milder (grade 1 to 2) and did not require treatment with epinephrine. A fourth single-center, double-blind, placebo-controlled trial, published by the same authors enrolled 98 adults with grass allergic rhinoconjunctivitis; 48 received grass patches and 50 received placebo. 1715 Treatment consisted of 6 weekly patches kept on for 8 hours. After treatment in the year 2009, median rhinitis symptoms improved by 48% in the treatment group vs 10% in the placebo group ( p = 0.003); a year later, this was 40% compared to 18% for placebo ( p = 0.43). There was no change in combined symptom and medication scores. CPT scores improved after the first year in the treatment group but not the placebo group. In the first year, allergen-specific IgG4 increased in the treatment group, while allergen-specific IgE decreased in the placebo group; there was no difference in both measures compared to baseline in the second year. Eight systemic reactions led to study exclusion. The authors concluded that this treatment strategy may have a potential role in treating IgE-mediated allergies, but further research was needed to find an optimal regimen that balances efficacy and safety. • Aggregate Grade of Evidence: B (Level 1b: 4 studies; Table IX.D.5). • Benefit: Transcutaneous immunotherapy resulted in limited and variable improvement in symptoms, medication use, and allergen provocation tests in patients with AR or conjunctivitis.

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