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

GlaxoSmithKline (GSK)

Status: Active, not recruiting

Conditions: Asthma

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06488703

222292

Details and patient eligibility

About

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.

Enrollment: 52,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52,000 participants in 2 patient groups

Participants with underlying condition (UC)

Description:

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

Description:

Participants with the same UC but without SCS treatment will be evaluated.