Psoriatic Arthritis Observational Study of Persistence of Treatment (PRO-SPIRIT Study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  SECUKINUMAB

  TOFACITINIB

  USTEKINUMAB

  APREMILAST
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  Tumor necrosis factor alpha (TNF-alpha) inhibitors
• Medical condition to be studied:
  Psoriatic arthropathy

Population studied

• 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)
• Estimated number of subjects:
  1620

Study design details

• Main study objective:
  To describe persistence at 24 months among patients with PsA who initiate a new bDMARD or tsDMARD treatment including any tumor necrosis factor inhibitor (TNFi), ustekinumab, apremilast, ixekizumab, secukinumab, and tofacitinib, regardless of the line of therapy.
• Outcomes:
  Persistence, PGA, HAQDI, PSAD
• Data analysis plan:
  Persistence at Month 24 will be evaluated by Kaplan-Meier analysis of the time spent usingthe same bDMARD or tsDMARD initiated at baseline.