Omalizumab in Food Allergy - Retrospective data analysis (OFAR)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, multi-center observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OMALIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX05) omalizumab

  omalizumab
• Medical condition to be studied:
  Food allergy
• Additional medical condition(s):
  IgE mediated food allergy

Population studied

• Short description of the study population:
  The study included patients from 9 to 59 years diagnosed with IgE-mediated food allergy who received omalizumab treatment between 2002 and 2022. ; Participants were identified through institutional records from allergy departments in Berlin, Leipzig, Barcelona, and Basel. ; Inclusion criteria required a confirmed history of food allergy—either with or without prior anaphylaxis—and treatment with omalizumab, either as monotherapy or in combination with oral immunotherapy.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  62

Study design details

• Study design:
  Retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). ; The study included patients with IgE-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy.
• Main study objective:
  To collect and analyse real-life data from patients who received omalizumab for the treatment of anaphylaxis.
• Outcomes:
  Primary endpoints: The number of anaphylactic reactions during treatment (over a treating period of 3-6-12-24 months).; Secondary endpoints:; 1. Quality of life outcomes during treatment (over a treating period of 3-6-12-24 months); 2. Collection of accidental reactions during treatment.; 3. Allergen threshold levels before and during treatment.; 4. Severity of anaphylactic reactions before and during treatment..
• Data analysis plan:
  The data were collected and entered into an Excel database. ; Analysis was conducted using IBM SPSS Statistics (version 27, Chicago, Ill)
• Summary results:
  Sixty-two patients (female n= 39/62, 62.9%; mean age 30.6 years) were included into this analysis, most of whom were polysensitized to more than 2 food allergens (n=40/62, 64.5%); 45/62 patients (72.6%) received OMA in conjunction with OIT, while the remaining patients underwent OMA monotherapy. ; The eliciting food allergens were tree nuts (n=27/62, 43.5%), cow’s milk (n=26/62, 41.9%), and vegetables (n=25/62, 40.3%). In most cases, OMA was initiated with 300 mg q4w (n=51/62, 82.3%) dosing. Treatment was tolerated exceptionally well.; Fifty-two (52/62) patients (83.9%) were classified as treatment responders. Six (6/62) patients (9.7%) developed unresponsiveness, 6/62 (9.7%) had a reduction of the severity of food allergy, and 40/62 (64.5%) had no further anaphylactic reactions during treatment. ; One (1/62) patient (1.6%) undergoing monotherapy was a non-responder, exhibiting repeated anaphylactic reactions to accidental exposures, and 10/62 patients (16.1%) reported anaphylactic reactions during treatment. ; In most of these cases, cofactors (n=5/10, 50%) were present. ;