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.