Prospective, multi-centre, non-interventional safety study to collect real-world data on the safety of immunotherapy with Depigoid® Katze in patients with allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia (LETI MIAU-KAT 2022)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-Authorization Safety Study

Study drug and medical condition

• Medical condition to be studied:
  Rhinitis
• Additional medical condition(s):
  allergic rhinitis/rhino-conjunctivitis due to feline epithelia

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  Depigoid® Katze is on the German market since 2022 and is used for the treatment of allergic illnesses triggered by feline epithelia. ; The objective of the present study is to collect and evaluate real world safety data in patients receiving the SCIT for moderate to severe allergic rhinitis and/or rh.
• Outcomes:
  • Number and severity of systemic reactions (World Allergy Organisation criteria) ; • Number and severity of local reactions ; • Onset of systemic and/or local reaction (immediate or late phase), ; • Comparison of two up-dosing regimens (Conventional vs Quick) with regard to primary variables ; • Comparison of two up-dosing regimens in terms of the proportion of patients reaching the maintenance treatment phase ; • Comparison of two up-dosing regimens with regard to the proportion of patients with local or systemic reactions ; • Development of the quality of life determined by SF-12 question
• Data analysis plan:
  Safety and clinical tolerability of the observed medication will be analyzed by the following parameters: ; • Number and severity of systemic reactions (World Allergy Organization criteria) in the entire study population (adolescents and adults) ; • Number and severity of local reactions in the entire study population (adolescents and adults) ; • Onset of systemic and/or local reaction (immediate or late phase) in the entire study population (adolescents and adults)
• Summary results:
  The study was started immediately after the market launch of the product in Germany and encountered a difficult medical-economic environment in which the reimbursement of the therapy was questioned. ; It is therefore not surprising that the recruitment period had to be extended and only around a quarter of the originally planned 400 patients were included. ; 91 patients were treated with the study medication, including 59 men and 32 women. 3 patients prematurely discontinued the study, they were dropped-out after V1 (1 patient), during V2 (1 patient) and after V4 (1 patient). 4 patients were screening failures before receiving the treatment. 88 patients completed the entire treatment course. ; Underage patients were also included in the study, so that nine adolescents between the ages of 13 and 16 took part in the study, together with 82 adult patients. Their ages ranged from 18 to 67 years. Regardless of the age group, around 50% of patients mainly reported delayed local side effects. ; Nevertheless, all but one patients reached the full maintenance dose and 88 out of 91 treated patients concluded the study. This is in clear contrast to other studies (Jutel, 2024) reporting drop-out rates of 20% or more. The number of systemic side effects documented – limited to grades 1 and 2 only - is comparatively low, mainly affected adults and in majority were delayed supporting the safety profile of Depigoid® Katze. ; In this study, in almost 100 patients no emergency hospitalisation or use of adrenaline were reported and confirms a significantly better safety profile than with native allergens for subcutaneous application (Lilja, 1989). ; To summarise, Depigoid® Katze – a chemically modified allergoid – provides a well-tolerated and safe immunotherapy option for patients with cat allergies in Germany. ; The observations made here largely correspond to those found in a recently published real world study in Spain (de La Torrea, 2024).;