Patients and Methods
In January 2019, physicians belonging to the French Study Group for Large Vessel Vasculitis (GEFA) were asked to include in a register their patients who received TCZ for the treatment of GCA for at least 2 months. GCA diagnosis was retained if the patient satisfied at least 3 criteria from the American College of Rheumatology, showed a positive temporal artery biopsy (TAB), or demonstrated large-vessel vasculitis on imaging. A standardized electronic form was sent to each physician who declared a patient. Anonymized data were thus collected in a centralized database.
In December 2020, 186 patients were included in the register, including 21 (11%) patients over 80 years old.
The Caen Ethical Board approved the study (CLERS ID265).
Data Collection and Definition
The data collection included demographics, cardiovascular risk factors (hypertension, hypercholesterolemia, diabetes mellitus, tobacco use), GCA-related cranial symptoms (headaches, scalp tenderness, jaw claudication, temporal artery abnormality, visual signs), polymyalgia rheumatica (PMR), limb claudication, fever, weight loss, acute phase reactants (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]), the results of histology (TAB or another vascular sample if available), the results of imaging, treatment regimens, and outcomes.
Regarding GC management, we retrieved the date of introduction, initial dose, dose at TCZ initiation and discontinuation, and duration of treatment. When GC tapering was not possible under a certain dose because of relapses, we qualified the disease as GC-dependent.
Regarding TCZ management, we noted the delay of introduction after GCs, duration of treatment, and route used (intravenous [IV] or subcutaneous [SC]). The indication for TCZ was noted among the four possible nonexclusive following criteria: GC-sparing effect, relapsing disease, severe GCA involvement (the severity of GCA was left to the physician's judgment), and failure of a previous immunosuppressant other than GCs.
Regarding TCZ tolerance, the following side effects were screened: infections, forms of cytopenia, hepatic or digestive toxicity, dyslipidemia requiring a specific medical treatment, or allergy. The Common Toxicity Criteria for Adverse Events (CTCAE) was used to grade the adverse events (scaling from 1 to 5), with the 5th grade corresponding to death.
Categorical variables are expressed as numbers (%), and quantitative variables are expressed as medians [range].
Arthritis Res Ther. 2021;23(143) © 2021 BioMed Central, Ltd.
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