Abstract
BackgroundRepeated low-dose grass pollen intradermal allergen injection suppresses allergen-induced cutaneous late-phase responses comparably with conventional subcutaneous and sublingual immunotherapy.ObjectiveWe sought to evaluate the efficacy and safety of grass pollen intradermal immunotherapy in the treatment of allergic rhinitis.MethodsWe randomly assigned 93 adults with grass pollen–induced allergic rhinitis to receive 7 preseasonal intradermal allergen injections (containing 7 ng of Phl p 5 major allergen) or a histamine control. The primary end point was daily combined symptom-medication scores during the 2013 pollen season (area under the curve). Analysis was by intention to treat. Skin biopsy specimens were collected after intradermal allergen challenges, and late-phase responses were measured 4 and 7, 10, or 13 months after treatment.ResultsThere was no significant difference in the primary end point between treatment arms (active, n = 46; control, n = 47; median difference, 14; 95% CI, −172.5 to 215.1; P = .80). Among secondary end points, nasal symptoms were worse in the intradermal treatment group, as measured based on daily (median difference, 35; 95% CI, 4.0-67.5; P = .03) and visual analog scale (median difference, 53; 95% CI, −11.6 to 125.2; P = .05) scores. In a per-protocol analysis intradermal immunotherapy was further associated with worse asthma symptoms and fewer symptom-free days. Intradermal immunotherapy increased serum Phleum pratense–specific IgE levels (P = .001) compared with those in the control arm. T cells cultured from biopsy specimens of subjects undergoing intradermal immunotherapy had higher expression of the TH2 surface marker CRTH2 (P = .04) and lower expression of the TH1 marker CXCR3 (P = .01), respectively. Late-phase responses remained inhibited 7 months after treatment (P = .03).ConclusionIntradermal allergen immunotherapy suppressed skin late-phase responses but was not clinically effective and resulted in worsening of respiratory allergic symptoms.
Highlights
Repeated low-dose grass pollen intradermal allergen injection suppresses allergen-induced cutaneous latephase responses comparably with conventional subcutaneous and sublingual immunotherapy
In 1926, Phillips,[6] a physician in Arizona, published a preliminary account of his experiences with intradermal grass pollen immunotherapy in 29 patients, which was extended to 322 patients by 1933,7 reporting that more than 90% obtained ‘‘satisfactory relief.’’ Here we report the findings of the first randomized placebocontrolled clinical trial of intradermal grass pollen injections for seasonal grass pollen allergy
Exclusion criteria included seasonal grass pollen–induced asthma requiring regular albuterol or inhaled corticosteroids; symptomatic seasonal allergic rhinitis, asthma, or both caused by tree or weed pollen overlapping the grass season requiring regular treatment; and perennial rhinitis and previous life-threatening anaphylaxis
Summary
Repeated low-dose grass pollen intradermal allergen injection suppresses allergen-induced cutaneous latephase responses comparably with conventional subcutaneous and sublingual immunotherapy. Nasal symptoms were worse in the intradermal treatment group, as measured based on daily (median difference, 35; 95% CI, 4.0-67.5; P 5 .03) and visual analog scale
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