Randomized clinical trial replication and second-stage study to evaluate the risk of serious infections in biological drug users with psoriatic arthritis and psoriasis using the Italian VALORE distributed database network

Study type

• Study topic:
  Human medicinal product
• Study topic, other:
  Biological drugs, risk of infection
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Population studied

• Short description of the study population:
  Replication: Subjects will be included according to the following steps:; - New users of secukinumab and adalimumab (defined as no previous use of adalimumab and secukinumab before the index date, i.e., the first dispensation) will be identified.; - At least 1 year of look-back (history in the database before the index date); - The index date must be after December 31, 2014, and before January 1, 2022.; o Rationale: The market authorization of secukinumab in Europe started on 01/2015, and the VALORE project collected data for each region at least until the end of 2022, allowing patients to be followed for at least one year after the index date (this was not true for Lazio region for which only data until 2020 were available). ; - See other inclusion and exclusion criteria for cohort entry. Inclusion and exclusion criteria were adapted from the EXCEED trial as closely as possible. Table A1 and Table A2 in the appendix show all the inclusion and exclusion criteria of the EXCEED trial with the respective emulation strategy and the flow chart of the study respectively.
• Special population of interest:
  Other
• Special population of interest, other:
  elderly