Utilization patterns, access to healthcare facilities and economic assessment of JAKi drugs used in rheumatoid arthritis patients in Tuscany: the LEONARDO study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  (L04AA37) baricitinib

Population studied

• Short description of the study population:
  In order to answer the research questions (RQ), we created three different study cohorts, as described in detail below.; For the RQ-1 and RQ-2, patients were identified by the first dispensation of a JAKi from January 1st, 2018 to December 31st, 2019. Cohort entry was defined by the first dispensation of a JAKi. We excluded patients with less than 10 years of records in the look back period, history of cancer or use of anti-cancer drugs in the look back period, as well as those aged ≤ 18 at the index date.; For the RQ-3 and RQ-4, patients were identified by the first dispensation of a JAKi from January 1 st, 2018 to June 30th, 2019. Cohort entry was defined by the first prescription of JAKi. Only patients with at least six months of observation after cohort entry were included. We excluded patients with less than 10 years of records in the look back period, history of cancer or use of anti-cancer drugs in the look back period, as well as those aged ≤ 18 at index date. In both the above analyses, patient observation was censored at the end of the study period, loss to follow-up, or death whichever came first.; For the RQ-5, patients were identified by the first prescription of a bDMARD from January 1st, 2014 to December 31st, 2019. Cohort entry was defined by the date of the first prescription of a bDMARD. We included patients with at least one visit in a Tuscan rheumatology ward in the year preceding the cohort entry. We excluded patients with less than 1 year of look back period.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  to identify and describe new users of JAKi in Tuscany from 2018 (year of approval in the treatment of severe to moderate RA) to 2019, and describe their utilization of the Regional Healthcare System facilities after treatment initiation, including an economic assessment
• Data analysis plan:
  Descriptive analysis (count, percentages)

Documents

Study results

Final report Leonardo (+ annexes)