According to MedPage Today, a recent study performed by researchers from the Vasculitis and Glomerulonephritis Center of Massachusetts General Hospital and Harvard Medical School found that patients with vasculitis had a high rate of relapse after treatment with Stelara. Read more about the study in Arthritis Care & Research.
Vasculitis is a condition referring to inflammation of the blood vessels, which can cause the vessels to narrow, stretch, or completely close. These all have different issues, from restricting blood flow and damaging tissue to causing an aneurysm. Vasculitis can be acute or chronic, and can affect different veins, arteries, or organs. Symptoms vary but can include fever, mouth ulcers, rash, weight loss, fatigue, swelling, and ear infections. It is believed that vasculitis occurs when the immune system mistakenly attacks the blood vessels.
In this particular study, researchers are examining giant cell arteritis. This is the most common type of vasculitis, according to the Johns Hopkins Vasculitis Center, and generally occurs in patients over the age of 50. Symptoms particular to this subset of vasculitis include headache, a tender scalp, jaw fatigue, muscle weakness, and an inflammatory disorder called polymyalgia rheumatica. Additional complications, found in up to 20-30% of patients, include blindness and an aortic aneurysm. Learn more about vasculitis here.
Researchers wanted to discover how effective and safe types of long-term vasculitis treatment could be. Prior treatment options have included glucocorticoids. However, many patients end up relapsing or developing issues with vision, diabetes, or brittle bones. While Actemra was once considered a potentially beneficial treatment, 1/3 of patients in an Actemra study relapsed within one year.
So, researchers decided to test the impact of treatment with ustekinumab (Stelara) alongside prednisone. 20 patients initially enrolled in the study.
All patients were Caucasian, with the mean age being 71 and most patients having ovaries. The study took place over a period of 2 years, during which 7 patients relapsed early and were removed from the trial. The remaining 13 patients received an injected dose of 90 mg of Stelara for 8 weeks, alongside a prednisone taper of 20-60 mg per day.
The mean time of relapse was around 23 weeks after 4 doses of Stelara. Six relapsed patients finished or nearly finished their prednisone doses.
During the course of the treatment, side effects included bone brittleness, weight gain, pneumonia, and infection.
Out of the 13 patients who finished the study, only 3 remained relapse free throughout the entire 52 weeks.
While researchers note that additional studies should be performed, it does suggest that Stelara is not the most effective in preventing vasculitis flares in the long-term.