Patients' Baseline Characteristics, but Not Tocilizumab Exposure, Affect Severe Outcomes Onset in Giant Cell Arteritis: A Real-World Study

Abstract

Objectives: Giant cell arteritis (GCA) is associated with severe outcomes such as infections and cardiovascular diseases. We describe here the impact of GCA patients’ characteristics and treatment exposure on the occurrence of severe outcomes. Methods: Data were collected retrospectively from real-world GCA patients with a minimum of six-months follow-up. We recorded severe outcomes and treatment exposure. In the survival analysis, we studied the predictive factors of severe outcomes occurrence, including treatment exposure (major glucocorticoids (GCs) exposure (>10 g of the cumulative dose) and tocilizumab (TCZ) exposure), as time-dependent covariates. Results: Among the 77 included patients, 26% were overweight (BMI ≥ 25 kg/m2). The mean cumulative dose of GCs was 7977 ± 4585 mg, 18 patients (23%) had a major GCs exposure, and 40 (52%) received TCZ. Over the 48-month mean follow-up period, 114 severe outcomes occurred in 77% of the patients: infections—29%, cardiovascular diseases—18%, hypertension—15%, fractural osteoporosis—8%, and deaths—6%. Baseline diabetes and overweight were predictive factors of severe outcomes onset (HR, 2.41 [1.05−5.55], p = 0.039; HR, 2.08 [1.14−3.81], p = 0.018, respectively) independently of age, sex, hypertension, and treatment exposure. Conclusion: Diabetic and overweight GCA patients constitute an at-risk group requiring tailored treatment, including vaccination. The effect of TCZ exposure on the reduction of severe outcomes was not proved here.

Keywords: cardiovascular events; diabetes; giant cell arteritis; glucocorticoids; infections; overweight; tocilizumab.

Figure 1

Flow chart of the selection of patients with giant cell arteritis followed at the Nimes University hospital.

Figure 2

Repartition of the subgroups of the 114 severe outcomes recorded in the 77 patients with giant cell arteritis after a prolonged follow-up. Cardiovascular diseases combine stroke, myocardial infarction, acute heart failure, aneurysm, and peripheral arterial disease. For hypertension and diabetes, new-onset or worsening of previous corresponding conditions are reported. Miscellaneous events encompass neuropsychiatric severe symptoms and gastrointestinal hemorrhage.

Figure 3

Risk of severe outcomes occurrence in the 77 patients with giant cell arteritis, according to the baseline characteristics (survival analysis). Survival curves illustrating severe outcomes onset according to the baseline characteristics in GCA patients. GCA, giant cell arteritis; TAB, temporal artery biopsy. The patients with baseline diabetes were at an increased risk of severe outcome onset (HR, 3.34 (1.52–7.35), p = 0.003) (A), as were the patients with baseline overweight (BMI ≥ 25 mg/m²) (HR, 2.06 (1.10–3.84), p = 0.023) (B), independently of age, sex, and baseline hypertension. (C) Among the patients with a TAB (n = 50), the patients with TAB positivity (n = 34) were at an increased risk of severe outcomes compared to the GCA patients with a negative TAB (HR, 5.34 (1.81–15.76), p = 0.002) independently of age, sex, overweight, and dyslipidemia (the association with diabetes and smoking was maintained). (D) The risk for the first infection was increased in the overweight GCA patients at baseline (HR, 2.47 (1.13–5.43), p = 0.024) independently of age, sex, diabetes, dyslipidemia, smoking, and major GCs exposure and TCZ exposure as time-dependent covariables.