Shortening the time to confirm or to rebut Adverse events of interest related to innovative Therapies for immune-mediated inflammATory dIseases: cross-talking between different data sOURces. SATURATIOn study.

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Systematic review and meta-analysis

Study drug and medical condition

• Name of medicine:
  CIMZIA

  COSENTYX

  ENBREL

  HUMIRA

  ILUMETRI

  JAKAVI

  KYNTHEUM

  OLUMIANT

  REMICADE

  RINVOQ

  SIMPONI

  SKYRIZI

  STELARA

  TALTZ

  TREMFYA
• Name of medicine, other:
  Biosimilars of these drugs when available
• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB

  BARICITINIB

  BRODALUMAB

  CERTOLIZUMAB PEGOL

  ETANERCEPT

  GOLIMUMAB

  GUSELKUMAB

  INFLIXIMAB

  IXEKIZUMAB

  RISANKIZUMAB

  RUXOLITINIB PHOSPHATE

  SECUKINUMAB

  TILDRAKIZUMAB

  UPADACITINIB

  USTEKINUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EJ01) ruxolitinib

  ruxolitinib

  (L04AA37) baricitinib

  baricitinib

  (L04AA44) upadacitinib

  upadacitinib

  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  Tumor necrosis factor alpha (TNF-alpha) inhibitors

  (L04AB01) etanercept

  etanercept

  (L04AB02) infliximab

  infliximab

  (L04AB04) adalimumab

  adalimumab

  (L04AB05) certolizumab pegol

  certolizumab pegol

  (L04AB06) golimumab

  golimumab

  (L04AC) Interleukin inhibitors

  Interleukin inhibitors

  (L04AC05) ustekinumab

  ustekinumab

  (L04AC10) secukinumab

  secukinumab

  (L04AC12) brodalumab

  brodalumab

  (L04AC13) ixekizumab

  ixekizumab

  (L04AC16) guselkumab

  guselkumab

  (L04AC17) tildrakizumab

  tildrakizumab

  (L04AC18) risankizumab

  risankizumab

  (L04AF) Janus-associated kinase (JAK) inhibitors

  Janus-associated kinase (JAK) inhibitors
• Medical condition to be studied:
  Psoriasis

  Psoriatic arthropathy

  Ankylosing spondylitis

  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Intervention group: Adult patients receiving TNFi for psoriasis (PsO), psoriatic arthritis (PsA), ankylosis spondylitis (AS), inflammatory bowel diseases (IBD); ;
• 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)

Study design details

• Study design:
  (1) Systematic review and network meta-analysis assessing the risk of Adverse events of interest in adult patients receiving biologics/targeted therapies for PsO, PsA, AS, or IBD comparing them against each other.; (2) Nationwide “exposed/unexposed” cohort study using the French health-insurance
• Main study objective:
  The aim of SATURATIOn is to shorten the time to confirm adverse events of interest related to innovative therapies for immune-mediated inflammatory diseases using the French National health-insurance data.
• Setting:
  France
• Comparators:
  Comparator group: Patients receiving other biological/targeted therapies (listed above) or placebo (only for RCTs) for the same diseases, with the same severity as in the intervention group to avoid selection bias.; Details of the two groups and preliminary data are available in the protocol (Table 1).
• Outcomes:
  Primary outcomes will be the following incident AEs of interest: ; • Heart failures and Major Adverse Cardiovascular Events (MACEs) (including nonfatal stroke, nonfatal myocardial infarction or cardiovascular death), ; • Serious infections (any infection meeting the regulatory definition of a serious adverse event, SAE) ; • Malignancies excluding non-melanoma skin cancer (NMSC) and carcinoma in situ of the cervix, ; • Psychiatric disorders (depression, suicidal ideation behaviour; neurotic, stress-related, or somatoform disorders; and personality and behavioural disorders) ; Secondary outcomes; • NMSC and carcinoma in situ of the cervix, ; • Demyelinating diseases and auto-immune diseases; • Pulmonary embolism and leg veinous thrombo-embolic events; • All reported events defined as SAEs. ;