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. Author manuscript; available in PMC: 2020 Jun 10.
Published in final edited form as: Int Forum Allergy Rhinol. 2018 Feb;8(2):108–352. doi: 10.1002/alr.22073

TABLE IX.D.6.

Evidence for the use of intralymphatic immunotherapy in the treatment of allergic rhinitis

Study Year LOE Study design Study groups Clinical endpoint Conclusion
Hylander et al.1719 2016 1b RCT, blinded Birch-pollen-induced or grass-pollen-induced AR (n = 36):

  1. Aluminum hydroxide adsorbed, depot birch-pollen or grass-pollen vaccine;

  2. Placebo

 Seasonal allergic symptoms by VAS, safety of injections, nasal symptom score following nasal provocation test, IgE and IgG4 levels, inflammatory cells, rescue medication use ILIT is effective and safe; results in a marked reduction of seasonal allergic symptoms.
Patterson et al.1720 2016 1b RCT, blinded Adolescents, grass-pollen-induced AR (n = 15):

  1. Aluminum hydroxide-adsorbed grass pollen extract;

  2. Placebo

 Patient diary score of allergy and asthma symptoms and medication use, local and systemic symptoms score after injections ILIT is effective and safe, with notably low adverse reactions.
Hylander et al.1718 2013 1b Pilot study and RCT, blinded Birch-pollen/grass-pollen-induced AR (pilot n = 6; RCT n = 15):

  1. Three intralymphatic inguinal injections of 1000 SQ-U birch pollen or grass pollen;

  2. Placebo

 Seasonal allergic symptoms by VAS, SPT, validated rhinitis QOL questionnaire ILIT is effective and safe.
Witten et al.1721 2013 1b RCT, blinded Grass pollen-induced AR (n = 45):

  1. 6 injections of 1000 SQ-U of depot grass pollen extract, minimal interval of 14 days;

  2. Three injections of 1000 SQ-U followed by 3 placebo injections;

  3. Six placebo injections

 Combined symptom and medication score, global seasonal assessment, RQLQ ILIT produced immunological changes but no improvement in symptoms.
Senti et al.1717 2012 1b RCT, blinded Cat-dander-induced AR (n = 20):

  1. MAT-Fel d 1;

  2. Placebo (saline in alum)

 Immunological parameters, systemic adverse effects, nasal provocation test, SPT, validated rhinitis QOL questionnaire ILIT with MAT-Fel d 1 (Recombinant major cat dander allergen fused to a modular antigen transporter) was safe and induced allergen tolerance after 3 injections.
Senti et al.1716 2008 2b RCT, open Grass pollen-induced AR (n = 165):

  1. Three 0.1-mL injections with 1000 SQ-U of aluminum hydroxide-adsorbed grass pollen extract injected into lymph node at day 0 and after 4 and 8 weeks;

  2. 54 subcutaneous injections over 3 years (cumulative dose of 4,031,540 SQ-U)

 Seasonal allergic symptoms by VAS, adverse events, safety of injections, rescue medication use, SPT, grass-specific IgE levels ILIT enhanced safety and efficacy of immunotherapy and reduced treatment time from 3 years to 8 weeks.
Schmid et al.1722 2016 4 Pilot study, open, no control group Grass-pollen-allergy-induced AR (n = 7):

  1. Three injections of 1000 SQ-U of allergen, dose interval 23-36 days

 Combined symptom and medication score, RQLQ, number of IgE+ and IgE− plasmablasts specific for grass ILIT may induce allergen-specific plasmablasts. Confirms an effect on provocation of mast cells in skin and nasal mucosa during the ensuing winter.

AR = allergic rhinitis; Ig = immunoglobulin; ILIT = intralymphatic immunotherapy; LOE = level of evidence; MAT = modular antigen transporter; QOL = quality of life; RCT = randomized controlled trial; RQLQ = Rhinoconjunctivitis Quality of Life Questionnaire; SPT = skin-prick test; SQ-U = standardized quality units; VAS = visual analogue scale.