Cardiovascular Diseases, Giant Cell Arteritis (GCA)
Conditions
Brief summary
This nationwide observational study emulates a target trial to compare the effect of tocilizumab versus methotrexate initiation on major adverse cardiovascular events (MACE) in patients with incident giant cell arteritis using the French National Health Data System (SNDS).
Detailed description
Study Design and Data Source This study is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. We emulated a hypothetical randomized trial comparing two treatment strategies: initiation of tocilizumab versus methotrexate within 6 months after hospital discharge for incident giant cell arteritis. Eligible patients aged ≥50 years hospitalized for incident GCA between 2012 and 2024 were included. Statistical Analysis A clone-censor-weight approach was used to account for treatment initiation timing and avoid immortal time bias. Inverse probability of censoring weights were applied to adjust for informative censoring. Treatment effects were estimated using weighted Kaplan-Meier methods and Cox proportional hazards models. Outcomes The primary outcome was the occurrence of major adverse cardiovascular events (MACE), defined as myocardial infarction, ischemic stroke, or all-cause death. Secondary outcomes included individual cardiovascular components, aortic events, and major vascular relapse. Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
Interventions
None listed
Sponsors
Groupe français d'étude des Maladies Inflammatoires de loeil
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥50 years Incident hospitalization for giant cell arteritis Initiation of tocilizumab or methotrexate within 6 months Received systemic corticosteroids ≥20 mg/day within 30 days following hospital discharge
Exclusion criteria
* Prior use of tocilizumab or methotrexate Age \>90 years Length of stay \>30 days Not discharged home Prior aortic disease or vascular imaging within 2 years Initiation of both treatments during grace period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 2 years | Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronary events | 2 years | Coronary events (myocardial infarction or unstable angina) |
| Ischemic stroke | 2 years | Ischemic stroke assessed at 2 years |
| All-cause mortality | 2 years | All-cause mortality assessed at 2 years |
| Aortic events | 2 years | Aortic events (aneurysm or dissection) |
| Major vascular relapse | 2 years | Major vascular relapse assessed at 2 years |
| Lower limb revascularization | 2 years | 7\. Lower limb revascularization assessed at 2 years |
| Anterior ischemic optic neuropathy (AION) | 2 years | Anterior ischemic optic neuropathy (AION) assessed at 2 years |
| Peripheral artery disease events | 2 years | Peripheral artery disease events assessed at 2 years |
| Cancer incidence | 2 years | Cancer incidence at 2 years |
Countries
France
Outcome results
None listed