Benefits of Pneumocystis jirovecii pneumonia prevention among patients with autoimmune or inflammatory disease treated with prolonged high dose steroids. (PaRADISE)

Study type

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

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01EE01) sulfamethoxazole and trimethoprim

  sulfamethoxazole and trimethoprim

  (P01CX01) pentamidine isethionate

  pentamidine isethionate

  (P01AX06) atovaquone

  atovaquone

  (P01BB51) proguanil and atovaquone

  proguanil and atovaquone

  (H02AB) Glucocorticoids

  Glucocorticoids
• Medical condition to be studied:
  Autoinflammatory disease

  Autoimmune disorder

  Immune system disorder
• Additional medical condition(s):
  Vasculitis, Sarcoidosis, Autoimmune arthritis, Autoimmune colitis, Autoimmune endocrine disorder, Autoimmune hepatitis, Autoimmune lung disease, Autoimmune myocarditis,Autoimmune demyelinating disease, Autoimmune dermatitis, Autoimmune myositis, Autoimmune pancreatitis, Autoimmune pericarditis, Autoimmune uveitis, Immune-mediated neurological disorder, Immune-mediated renal disorder.

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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  6700000

Study design details

• Main study objective:
  The main aim of this study is to assess the effect of Pneumocystis jirovecii pneumoniaprophylaxis (i.e. TMP-SMX or aerosolized pentamidine or atovaquone) to prevent PJP among IAD patients treated with prolonged high dose steroids .
• Outcomes:
  Time to Pneumocystis jirovecii pneumonia Diagnosis, Time to severe PJP prevention side effects (requiring hospitalization) for patients receiving PJP prophylaxis: - severe drug-induced cutaneous injury, - severe drug-induced liver or kidney injury, - lupus induction, - severe cytopenia, Time to death, in patients with PJP globally and by type of IAD, and in patients with incident IAD by type of IAD
• Data analysis plan:
  PJP rates will be compared only within periods at risk of PJP (i.e. with high dose steroids greater than 20 mg daily (1 month or more) with or without PJP prophylaxis. We will make a dynamic matching on a time dependent propensity score. In order to have reasonable power in subgroup analysis by IAD, the matching will be stratified on the type of disease. Only the first line of high dose steroid treatment will be used in main analysis. Then a Cox model will be used, with time dependent confounding variables if needed. The propensity score will take into account known risk factors of PJP and confounding factors for the association of interest.