WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids. The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).

Official Title
-----------------
WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Cumulative corticosteroid exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed SLE as per ACR criteria No history of case event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Incident diabetes cases<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with diabetes during follow-up, subsequent to SLE diagnosis. | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident diabetes controls<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of diabetes during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident hypertension cases<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with hypertension during follow-up, subsequent to SLE diagnosis. | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident hypertension controls<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of hypertension during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident cataract cases<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with cataract during follow-up, subsequent to SLE diagnosis. | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident cataract controls<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of cataract during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident osteoporosis cases<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with osteoporosis during follow-up, subsequent to SLE diagnosis. | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident osteoporosis controls<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of osteoporosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident avascular necrosis cases<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with avascular necrosis during follow-up, subsequent to SLE diagnosis | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|
| Incident avascular necrosis controls<br>Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of avascular necrosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ | Drug: Cumulative corticosteroid exposure<br>* Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis | New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis recorded after SLE diagnosis in the Hopkins Lupus cohort | Over a period of 25 years from 1987-2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, avascular necrosis, systemic lupus erythematosus, osteoporosis, Steroid, diabetes, cataracts