What the trial was testing
The trial enrolled 30 patients with giant cell arteritis. The study was sponsored by Massachusetts General Hospital and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was long-term safety (phase 4). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
77% reached steroid-free remission at one year.
The Lancet Rheumatology · 2023 · NCT03726749
These findings — that at one year on tocilizumab plus only 8 weeks of steroids for giant cell arteritis — were published in the The Lancet Rheumatology and represent the headline result of the study.
Researchers tracked outcomes across 30 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with giant cell arteritis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Tocilizumab (Actemra) is FDA-approved and available now for giant cell arteritis. The standard plan still uses 6+ months of steroids, but this small study suggests much shorter steroid courses may be possible. Ask a rheumatologist about reducing steroid exposure if you have GCA.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open giant cell arteritis trials
Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
Large vessel vasculitis (LVV) is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase. It has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin. Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been shown to improve blood vessel function and stiffness in patients with diabetes. The investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will be given Bosentan and Dapagliflozin for 6 weeks, followed by Dapagliflozin for 4 weeks, to evaluate their impact on blood vessel function.
Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.