Observational Study of the Safety of an Ultra-Rush Sublingual Immunotherapy Regimen to Treat Rhinitis due to House Dust Mites

Abstract

Background: Ultra-rush regimens for administering sublingual immunotherapy to patients with allergies are becoming more widespread. We aimed to assess treatment safety for patients with allergic rhinitis with or without asthma caused by Dermatophagoides house dust mites. Methods: This observational study at 5 Spanish centers included 218 patients aged 4–64 years, of whom 117 were women and 122 were under 15 years old. Ultra-rush regimen consisted of incremental doses of an allergen extract comprising a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (30, 60, 120, 240 IR every 30 min) followed by maintenance therapy. Adverse reactions were monitored and asthmatic patients underwent spirometric testing at baseline and after each dose. Follow-up was scheduled after 2 weeks of maintenance with 240 IR three times a week. Results: Five patients had to modify ultra-rush regimen because of mild local adverse reactions. In total, 32 adverse reactions were reported in 27 patients during the ultra-rush regimen. Seven of these events were local gastrointestinal reactions, and the remaining 17 were local reactions, mainly labial or mouth itching and burning. Eight events were systemic reactions [rhinitis (n = 3), general malaise (n = 1), general malaise and vomiting (n = 1), dizziness (n = 1), asthma (n = 1), dyspnea (n = 1)]. All adverse reactions were mild or moderate. Serious adverse events or life-threatening anaphylactic reactions were not reported. Conclusions: High-dose sublingual immunotherapy with Dermatophagoides allergen extracts can be safely administered in an ultra-rush regimen, although its usefulness and benefit for perennial allergens (e.g. house dust mites) must be evaluated.

Sublingual immunotherapy: World Allergy Organization position paper 2013 update

“…• Age: 2 of the rhinitis studies [54,66], 1 also including asthmatic children [66], and 1 safety trial [97] included children ≥4 years old, and 1 food-allergy trial included children ≥1 year old [134]. Therefore, we now have medium-quality preliminary evidence of SLIT efficacy for rhinitis in children from 4 years of age [54].…”

Role of sublingual immunotherapy in the treatment of asthma: An updated systematic review

“…Our search identified a total of 33 articles on 30 unique studies/populations reporting safety data, encompassing a total of 3621 patients. Of the included studies, 20 were RCTs, whereas 10 were either cohort, case‐control, or case reports . Details regarding these studies are presented in Appendix Table S2 online.…”

Mechanisms of allergen-specific immunotherapy

“…An increase in Treg cells along with a Th2 to Th1 switch has been shown to occur already during the first 24 h [106]. This type of time regime is now also being investigated in SLIT [107].…”