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High dose pollen intralymphatic immunotherapy: two RDBPC trials question the benefit of dose increase
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  • Laila Hellkvist,
  • Eric Hjalmarsson,
  • Dan Weinfeld,
  • Alsog Dahl,
  • Agneta Karlsson,
  • Marit Westman,
  • Karin Lundkvist,
  • Ola Winquist,
  • Susanna Kumlien Georén,
  • Ulla Westin,
  • Lars Olaf Cardell
Laila Hellkvist
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik
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Eric Hjalmarsson
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik
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Dan Weinfeld
Sodra Alvsborgs sjukhus Boras
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Alsog Dahl
Goteborgs universitet Institutionen for Biologi och Miljovetenskap
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Agneta Karlsson
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik
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Marit Westman
Karolinska Institutet Institutionen for medicin Solna
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Karin Lundkvist
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik
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Ola Winquist
ABC labs Biomedicum Stockholm Sweden
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Susanna Kumlien Georén
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik
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Ulla Westin
Skanes universitetssjukhus Lund
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Lars Olaf Cardell
Karolinska Institutet Institutionen for klinisk vetenskap intervention och teknik

Corresponding Author:[email protected]

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Abstract

Background The same dosing schedule, 1000 SQ-U times three, with one-month intervals, have been evaluated in most trials of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis (AR). The present studies evaluated if a dose escalation in ILIT can enhance the clinical and immunological effects, without compromising safety. Methods Two randomized double-blind placebo-controlled trials of ILIT for grass pollen induced AR were performed. The first included 29 patients that had recently ended 3 years of SCIT and the second contained 39 not previously vaccinated patients. An up-dosage of 1000-3000-10 000 (5000 + 5000 with 30 minutes apart) SQ-U with one month in between was evaluated. Results Doses up to 10 000 SQ-U was safe after recent SCIT. The combined symptom-medication scores (CSMS) were reduced by 31% and the grass specific IgG4 levels in blood were doubled. In ILIT de novo, the two first patients that received active treatment developed serious adverse reactions at 5000 SQ-U. A modified up-dosing schedule; 1000-3000-3000 SQ-U appeared to be safe but failed to improve the CSMS. Flow cytometry analyses showed increased activation of lymph node derived dendritic but not T-cells. Quality of life and nasal provocation response did not improve in any study. Conclusion ILIT in high doses after SCIT appears to further reduce grass pollen induced seasonal symptoms and may be considered as an add-on treatment for patients that do not reach full symptom control after SCIT. Up-dosing schedules de novo with three monthly injections that exceeds 3 000 SQ-U should be avoided.
24 Jun 2021Submitted to Allergy
28 Jun 2021Assigned to Editor
28 Jun 2021Submission Checks Completed
30 Jun 2021Reviewer(s) Assigned
18 Jul 2021Review(s) Completed, Editorial Evaluation Pending
19 Jul 2021Editorial Decision: Accept