Safety of uSCIT-MPL-4: prevalence and risk factors of systemic reactions in real life

Immunotherapy. 2019 Jun;11(9):783-794. doi: 10.2217/imt-2019-0009. Epub 2019 May 16.

Abstract

Aim: We assessed the safety of allergoid adjuvanted by monophosphoryl lipid A (uSCIT-MPL-4) in a real-life setting. Materials & methods: Patients treated with uSCIT-MPL-4 were followed-up for 1 year. Systemic reactions (SRs) were registered and the association with potential risk factors was evaluated. Results: 2929 patients were included. Grade 0, 1, 2, 3 and 4 SR reactions were observed respectively in 3.3, 1.5, 0.31, 0.07 and 0.07% of patients. A significant association was detected between Grade ≥1 SRs and: female gender, number of administrations, previous local reactions. Conclusion: uSCIT-MPL-4 is safe. Local reactions should be accurately assessed as they may represent a risk factor for Grade ≥1 SRs, together with gender and number of doses/year.

Keywords: adjuvants; allergic asthma; allergic rhinitis; immunotherapy; local reactions; risk factors; safety; subcutaneous immunotherapy; systemic reaction grading system; systemic reactions.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adjuvants, Immunologic / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Asthma / complications*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Hypersensitivity / drug therapy*
  • Hypersensitivity / epidemiology
  • Hypersensitivity / etiology
  • Italy / epidemiology
  • Lipid A / analogs & derivatives*
  • Lipid A / therapeutic use
  • Male
  • Middle Aged
  • Prevalence
  • Prospective Studies
  • Rhinitis, Allergic, Seasonal / complications*
  • Risk Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • Lipid A
  • monophosphoryl lipid A