Common autoimmune drug shown to help patients with giant cell arteritis

A common medication already used for autoimmune diseases such as rheumatoid arthritis is effective for patients with giant cell arteritis, according to findings from a team at the Perelman School of Medicine at the University of Pennsylvania published in the New England Journal of Medicine. Causing the body’s immune system to attack blood vessels in the head, neck, and other areas, giant cell arteritis often leads to headaches, vision loss, and even aortic aneurysms. But nearly half of patients taking upadacitinib in a new Phase 3 clinical trial achieved sustained remission- while reducing their dependence on glucocorticoids (typically called “steroids”), the most common treatment. By comparison, less than 30 percent of patients who took a placebo achieved remission. 

The side effects of treatment with glucocorticoids negatively impacts most patients with giant cell arteritis, often severely. Having the option to use upadacitinib for this disease is a big win because it could help patients stop taking glucocorticoids, control their disease, and improve their quality of life.” 

Peter A. Merkel, MD, MPH, senior author, chief of Rheumatology, a professor Rheumatology and Epidemiology, and director of the Penn Vasculitis Center

An attractive target 

The main current treatment for giant cell arteritis includes the daily use of glucocorticoids, especially prednisone. Unfortunately, glucocorticoids can impact patients with serious side effects such as weight gain, diabetes, osteoporosis, high blood pressure, and infections. 

However, because researchers have already determined that a cellular communication pathway called the JAK-STAT signaling pathway plays a significant role in giant cell arteritis, it presents an alternate treatment target, particularly for Janus kinase (JAK) inhibitors, which can block interleukin-6, interferon-y, and other proteins called cytokines that are key to inflammation generated by the immune system. 

Sustained remission 

The new trial included 100 sites across 24 countries. Patients with giant cell arteritis treated daily with prednisone were randomized to one of three different groups: the control group that received placebo medications; a group that received 7.5 milligrams of upadacitinib daily; and a group that received 15 milligrams of upadacitinib daily. All groups were expected to slowly but completely reduce their prednisone use: by week 52 for the placebo group and week 26 week for the upadacitinib groups. 

At the end of their participation in the year-long study, 46 percent of those taking the higher dose of upadacitinib achieved sustained remission, meaning that they had no signs or symptoms of giant cell arteritis between weeks 12 and 52, a clinically and statistically significant benefit. That was compared to 29 percent for the placebo group that achieved remission. In the lower dose upadacitinib group, 41 percent achieved remission, but this was not statistically significantly different from the placebo group. 

Safety measures also excellent 

In addition to measuring remission, the study’s researchers also investigated some secondary effects of taking upadacitinib, including how long a remission lasted, how long until relapse of symptoms, and how much prednisone, overall, that patients took. In those measures, the higher dosage of upadacitinib was superior or equal to the placebo. 

When the researchers looked at safety measures, upadacitinib was equal to the placebo, meaning it didn’t add any additional harm, such as side effects or worse, to patients. 

This study was funded by AbbVie, which makes a brand-name version of upadacitinib.