Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older
than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and
course of GCA, reducing the likelihood of vascular complications that could lead e.g. to
blindness. However, relapses usually occur when GC dosages are tapered, resulting in frequent
re-treatment with high cumulative dosages of GC over time with substantial toxicity and
morbidity (e.g. diabetes mellitus, infections, enhanced cardiovascular risk, osteoporotic
Therefore, novel therapies are needed that effectively reduce the dose and duration of GC
treatment and provide more durable remissions of GCA.
Tocilizumab (TCZ) is a humanized monoclonal antibody directed against the human interleukin-6
receptor (IL-6R). Elevated tissue and serum levels of IL-6 have been implicated in giant cell
arteritis. Inhibition of IL-6 and/or its receptor therefore represents a new and novel
approach for the treatment of RA.
The primary endpoint is the proportion of patients that have achieved complete remission of
disease after treatment with TCZ compared to treatment with placebo at week 12. All patients
will receive glucocorticoids in a standardized form.