Long-term, observational cohort study of adults with plaque psoriasis (PsO), who are new users of deucravacitinib, tumour necrosis factor inhibitor (TNFi) biologics, non-TNFi biologics, or non-biologic therapies in the real-world clinical setting

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study

Study drug and medical condition

• Name of medicine:
  SOTYKTU
• Study drug International non-proprietary name (INN) or common name:
  DEUCRAVACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF07) deucravacitinib

  deucravacitinib
• Medical condition to be studied:
  Psoriasis
• Additional medical condition(s):
  Plaque Psoriasis

Population studied

• Short description of the study population:
  The study will include adult patients in Europe with diagnosed Plaque Psoriasis (PsO) who are new users of deucravacitinib or treatments from 1 of the 3 comparator cohorts during the indexing period.;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

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

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  12800

Study design details

• Study design:
  This is an observational cohort study using longitudinal real-world data from 6 databases and/or established disease registries in Europe. PsO treatment episodes for each patient will be classified into 4 cohorts: deucravacitinib, non-TNFi biologics, TNFi biologics, and non-biologic therapies.
• Main study objective:
  The primary objective of this study is to estimate the incidence rates of serious/select infections, malignancies, and select cardiovascular (CV) events among adult patients with PsO who are new users of deucravacitinib or treatments in 1 of the 3 comparator cohorts (CV events of interest are MACE, eMACE, and VTE) and to compare the risk of serious/select infections, malignancies, and select CV events (MACE, eMACE, and VTE) between deucravacitinib and each of the 3 comparator cohorts.
• Outcomes:
  The outcomes measured for this study include serious/select infections, malignancies, select CV events (MACE, eMACE, and VTE), and fatal events of the safety outcomes.
• Data analysis plan:
  Descriptive statistics for baseline demographic data, clinical characteristics, and duration of exposure will be presented by treatment cohort.; Incidence rates and 95% confidence intervals (CIs) will be calculated for each outcome of interest over the entire observation period and at 1 year, 3 years, and 5 years of follow-up. Incidence rates will be reported overall for each treatment cohort and stratified by whether or not patients were PsO treatment-experienced (ie, received a systemic therapy from 1 of the other treatment cohorts prior to their episode index date except for deucravacitinib).; For each outcome of interest, weighted Cox proportional hazards regression models will be developed to estimate adjusted (ie, marginal) hazard ratios (HR) and 95% CIs for deucravacitinib versus each of the 3 comparator cohorts (pairwise comparisons). Inverse probability of treatment weighting (IPTW) based on propensity score (PS) will be used to account for observed differences in characteristics across the treatment cohorts.; Patients can contribute multiple treatment episodes to each analysis, so the resulting correlated variance will be reflected in the final analysis using a robust variance estimator. Additionally, several sensitivity analyses will be conducted to assess the robustness of the results.