Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
NCT Number: NCT06488703
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Asthma
Sponsor: GlaxoSmithKline
Collaborators: Vandage GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-11-30

Summary:
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic conditions associated with chronic inflammatory diseases. Limited data are available about long-term- Systemic (cortico)steroids / systemic glucocorticoids (SCS) related side effects. Oral (cortico)steroids / systemic glucocorticoids (OCS) mediated side effects in e.g., rheumatic diseases are not consistently determined. No sufficient cohort analysis determined systematically possible side effects of SCS in the long-term. This study will close this major gap by delivering data about long-term SCS side effects (risk stratification via SCS dose, treatment duration). Therefore, the primary objective of PROGRESS is to quantify the risk of adverse outcomes among populations with specific underlying conditions (UC) with and without exposition to systemic glucocorticoid therapy in Germany. The secondary objective is to analyze the influence of dosage and time of systemic glucocorticoid therapy exposition on the risk of adverse outcomes among these populations with specific UCs. In general, it is evident that a frequent SCS exposure leads to side effects like diabetes or osteoporosis etc., which have the potential to become a major financial burden to healthcare systems. For this reason, the tertiary objective is to quantify the economic burden associated with the incidence of adverse outcomes related to SCS exposition among populations with specific UCs for the German market. The study design will be a retrospective cohort study (claims data) based on a rolling cohort design using an exact matching approach. Persons with different UCs and with SCS treatment exposition are matched to controls with UC but without SCS treatment. Matching will be performed on a quarterly basis. First patient-in is in 01/2009, last patient-in in 12/2020. The study period covers data from 01/2007 to 12/2022. The study population are adult patients with confirmed diagnosis of Bronchial Asthma, COPD, Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis (EGPA), Chronic rhinosinusitis (CRS), Crohn's disease, or Ulcerative colitis in Germany.

Primary Outcome Measures: Percentage of Participants with specific Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids, Percentage of participants with specific adverse outcome among participants with UC with exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia., Up to 7 months|Percentage of Participants with any Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids, Percentage of participants with any adverse outcome among participants with UC with exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia., Up to 7 months|Percentage of Participants with specific Adverse outcome in participants with UC without exposition of systemic glucocorticoids, Percentage of participants with specific adverse outcome among participants with UC without exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia., Up to 7 months|Percentage of Participants with any Adverse outcome in participants with UC without exposition of systemic glucocorticoids, Percentage of participants with any adverse outcome among participants with UC without exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia., Up to 7 months
Secondary Outcome Measures: Percentage of Participants with specific Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time., Percentage of participants with specific adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia., Up to 7 months|Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time., Percentage of participants with any adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed., Up to 7 months|Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy without exposition related to dosage and time., Percentage of participants with any adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed., Up to 7 months