ImPact of comoRbidity In Severe asthMa patients (PRISM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OMALIZUMAB

  MEPOLIZUMAB

  BENRALIZUMAB

  RESLIZUMAB

  DUPILUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX05) omalizumab

  omalizumab

  (R03DX09) mepolizumab

  mepolizumab

  (R03DX10) benralizumab

  benralizumab

  (R03DX08) reslizumab

  reslizumab

  (D11AH05) dupilumab

  dupilumab
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Eligible participants are patients aged 18 years or more who visit a participating centre, have a diagnosis of severe asthma, and are willing to contribute with their data.
• Age groups:
  • 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:
  11000

Study design details

• Study design:
  Cross-sectional & longitudinal cohort
• Main study objective:
  To understand the pattern of comorbidities in adults with severe asthma and investigate their association with asthma-related outcomes
• Outcomes:
  The prevalence of comorbidities will be described in patients with severe asthma. The impact of T2-related comorbidities on response to biologics will be assessed
• Data analysis plan:
  1. Overall prevalence of history of individual comorbidities (ever/never) will be calculated over the timeframe covered by ISAR. In addition, the number of comorbidities will be calculated for each patient and prevalence of comorbidity counts computed (eg, prevalence of 0, 1, 2, and 3+ comorbid conditions). 2.The prevalence estimates will be compared between demographic and clinical features: - through chi-square tests for categorical variables, - through t-test comparisons or non-parametric Wilcoxon tests for continuous variables. 3.For patients initiating biologics, we will compare patients with at least one T2 comorbidity or without T2 comorbidity, and by individual T2 comorbidity types, with respect to four asthma-related outcomes measured the period 24 weeks to 1 year following the biologic initiation:exacerbation rate (risk ratios), asthma control (difference of proportions), lung function (difference of means or medians), cumulative OCS dose (difference of means or medians)
• Summary results:
  In the real world, comorbidities are highly frequent in adults with severe asthma and multi comorbidity is common. The presence of comorbidity is generally associated with poorer asthma-related outcomes. However, patients with allergic rhinitis, chronic rhinosinusitis and nasal polyposis tend to experience an enhanced response to biologics in terms of exacerbation rates (all three comorbidities), lung function (allergic rhinitis and chronic ; rhinosinusitis), and asthma control (all three comorbidities). The impact of these comorbidities on biologic response is globally more apparent in patients initiating anti-IL5/5R than in patients initiating anti-IgE. Overall, the PRISM study highlights the importance of systemic evaluation for comorbidities and a multidisciplinary approach to their management in patients with severe asthma.