Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications

Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications [PROGRESS Study]

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.

Study Overview

• Status: Completed
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Actual): 107032

Contacts and Locations

Study Locations

• Germany
  • Germany, Germany
    • Rwth Aachen University-Aachen-Germany-C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will enroll participants who meets the below inclusion/exclusion criteria.

Description

Inclusion Criteria:

• Male or female, aged 18 years or older.
• Prevalent diagnosis of an underlying condition.
• At least two years of pre observation period. The same inclusion criteria apply to the matched control group, excluding the initiation of Systemic (cortico)steroids / systemic glucocorticoids (SCS) treatment.

Exclusion Criteria:

• Have a record of defined SCS-related adverse outcome within two years before index date.
• Have a history of breast cancer and / or tamoxifen prescription

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants with underlying condition (UC); Participants with UCs (Bronchial Asthma, coronary obstructive pulmonary disorder [COPD], Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis [EGPA], Chronic rhinosinusitis [CRS], Crohn's disease, and Ulcerative colitis) with Systemic (cortico)steroids/systemic glucocorticoids (SCS) exposure will be evaluated.
Matching control group; Participants with the same UC but without SCS treatment will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Vandage GmbH
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lupus; Asthma; Crohn's disease; Ulcerative colitis; Vasculitis; Chronic obstructive pulmonary disease (COPD); Eosinophilic granulomatosis with polyangiitis (EGPA); Rheumatism; PROGRESS; Systemic (cortico)steroids / systemic glucocorticoids; Long term OCS side effects; OCS side effects; SCS side effects; Long term SCS side effects; Chronic rhinosinusitis with nasal polyps (CRSwNP)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Intestinal Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Colonic Diseases; Skin Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Skin Diseases, Vascular; Colitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granuloma; Systemic Vasculitis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Pulmonary Disease, Chronic Obstructive; Asthma; Colitis, Ulcerative; Crohn Disease; Churg-Strauss Syndrome; Vasculitis; Rheumatic Diseases
• Other Study ID Numbers: 222292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR