Impact of biologics on inhaled corticosteroids reduction (MOON LIGHT)

Study type

• Study topic:
  Human medicinal product
• 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:
  Cohort

Study drug and medical condition

• Medicinal product name:
  CINQAERO

  DUPIXENT

  FASENRA

  NUCALA

  TEZSPIRE

  XOLAIR
• Medicinal product name, other:
  Cinqair, Dupilumab, Mepolizumab, Omalizumab, Reslizumab, Tezepelumab

Population studied

• Short description of the study population:
  Patients diagnosed with severe asthma from 26 countries enrolled in ISAR.
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)

Study design details

• Study design:
  Observational longitudinal study
• Main study objective:
  Objective 1: To calculate the extent of reduction in ICS, SABA, and triple therapy use after biologic initiation. ; Objective 2: To identify potential predictors of successful down titration of ICS, SABA, and triple therapy use for those receiving biologic therapy.
• Setting:
  The study population will be extracted from the International Severe Asthma Registry database (data collected between 2017 and 2025). Patients meeting the following inclusion criteria will be included in this study ; ; - Documented initiation of biologic therapy, AND ; ; - Severe Asthma diagnosis (severe defined as ≥2 exacerbations and medium dose ICS/LABA OR high ICS/LABA) ; ; - Age 18 years or older at the time of biologic initiation, AND ; ; - Record of biologic initiation date, AND ; ; - Pre-bx ICS dose data (before bx initiation date) and at least one follow-up visits with ICS dose data post-bx, ; ; - Patient data / recorded assessment available in baseline ; ; ; Patients with the following exclusion criteria will not be included in this study: ; ; - Biologic received for other (non-asthma) conditions (e.g. Urticaria, atopic dermatitis, EGPA, CRSwNP without severe asthma)
• Comparators:
  reducers vs non-reducers of ICS dose ; ; those that stepped down from triple therapy vs those that did not (patients on triple therapy in the baseline year). ; ; reducers vs non-reducers of SABA (OPCRD only).
• Outcomes:
  ICS reduction (mcg, continuous) ; ; ICS reducer – baseline is higher than the final ICS dose at follow-up times (6 months, 1 year, 2 year) ; ; ICS non-reducer – baseline is equal to or lower than the final ICS dose at follow-up times (6 months, 1 year, 2 year) ; ; SABA prescriptions (count) ; ; Triple therapy (binary [stepped down to dual – yes or no])
• Data analysis plan:
  Logistic regression models will be used to test for associations between baseline characteristics (including year of biologic initiation) and the odds of being an ICS reducer vs non-reducer at 12 months and 24 months after biologic initiation.
• Summary results:
  In this large, multinational real-world study of patients with severe asthma, initiation of biologic therapy was associated with gradual but durable reductions in inhaled corticosteroid dose, modest decreases in SABA use, and limited but measurable step-down from triple therapy over five years of follow-up. Although most patients remained on their baseline inhaled therapy intensity, a meaningful minority achieved clinically relevant and durable reductions, with strong year-on-year persistence once down-titration occurred. Marked variation between countries suggests that the extent of inhaled therapy reduction is influenced by local clinical practice and healthcare systems, and that greater de-escalation may be achievable in some settings. Predictors of reduction were few, indicating that opportunities for safe inhaled-therapy de-escalation extend across a broad patient ; population rather than being limited to specific phenotypes. These findings provide robust global evidence (noting the observational nature of the data) that biologics can support inhaled therapy optimisation in routine clinical practice, reinforcing guideline recommendations to consider ICS tapering once asthma control is achieved. ; Future work should focus on defining structured, evidence-informed pathways for step-down and evaluating clinical outcomes associated with inhaler de-escalation to further support personalised, corticosteroid-sparing care.