Risk of serious infections with bDMARDs in psoriasis/psoriatic arthritis patients: a large-scale cohort study using the Italian VALORE Project distributed database

Study type

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

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  INFLIXIMAB

  ETANERCEPT

  CERTOLIZUMAB

  GOLIMUMAB

  BRODALUMAB

  IXEKIZUMAB

  SECUKINUMAB

  BIMEKIZUMAB

  GUSELKUMAB

  RISANKIZUMAB

  TILDRAKIZUMAB

  USTEKINUMAB

  ABATACEPT
• Medical condition to be studied:
  Psoriasis

  Psoriatic arthropathy

Population studied

• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  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:
  15000

Study design details

• Main study objective:
  To evaluate the association between the use of individual bDMARDs approved for PsO/PsA treatment and the occurrence of severe infection risk in an Italian real-world setting in the years 2010-2021 among different drug class (TNF-alpha inhibitors, IL inhibitors, T cell modulator), using the large-scale “VALORE” project distributed database network.
• Outcomes:
  To assess the incidence of severe infection between bDMARDs in monotherapy and in combination therapy with csDMARDs and/or systemic corticosteroids.
• Data analysis plan:
  The study aims to describe the characteristics of incident users of biologic Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) using means, standard deviations, and frequencies. Differences between bDMARDs users are assessed using standardized difference (d), t-tests, and Chi-Square or Fisher tests. The primary objective is to estimate the incidence of severe infections between different bDMARD classes (TNF alpha vs IL-inhibitors/Selective Immunosuppressive agents) using Propensity Score matching and Cox Proportional-Hazards models. The incidence will be reported per 100 person-years. Two additional objectives involve estimating the effect of bDMARD classes and combinations (bDMARDs alone vs with corticosteroids or csDMARDs) on the incidence of serious infections requiring hospitalization. These will also use Cox models, both in unmatched and matched cohorts. Sensitivity analyses will treat drug exposure as a time-dependent variable without censoring for drug switches or discontinuation