Adding a newer drug to standard corticosteroid treatment of giant cell arteritis does not help to reduce the dose of corticosteroids needed.
INTRODUCTION
Giant cell arteritis is a condition where the large blood vessels of the head and neck become inflamed. It can cause soreness around the temples, pain in the jaw while eating, and (if untreated) sight loss. The main treatment for giant cell arteritis is a one- or two-year course of corticosteroid medicine to reduce and control the
inflammation in the blood vessels.
However, taking corticosteroids for a long time can cause side effects, including mood changes, increased appetite leading to weight gain, and an increased chance of getting infections. For this reason, doctors would like to find a way to control giant cell arteritis with lower doses of steroids, for a shorter time. Doctors thought
a drug called adalimumab, which affects the immune system by blocking a substance called tumour necrosis factor, might help. Adalimumab is approved and widely used for treatment of inflammatory joint diseases like rheumatoid arthritis, anlylosing spondylitis and psoriatic arthritis and also for treatment of psoriasis and inflammatory bowel diseases.
WHAT DID THE RESEARCHERS HOPE TO FIND?
The researchers wanted to see how much people who took injections of adalimumab could reduce their dose of corticosteroid medicine by, while still keeping the inflammation of the blood vessels under control.
WHO WAS STUDIED?
Researchers studied 70 people aged at least 50, with giant cell arteritis, from 23 departments of rheumatology or internal medicine in France.
HOW WAS THE STUDY CONDUCTED?
People in the study were randomly assigned either to have injections of adalimumab or a placebo (dummy) injection every two weeks. All people in the study took corticosteroids, with a starting dose of 0.7 milligrams (mg) for every kilogram the person weighed, every day.
Doctors reduced the dose of corticosteroids every two weeks in people who had no clinical symptoms of giant cell arteritis, and if their blood tests showed inflammation levels below a certain point. People who had no symptoms and blood tests showing low inflammation were said to be ‘in remission’. After 26 weeks (six months), doctors looked to see how many patients were in remission and taking a daily corticosteroid dose of less than 0.1 mg for every kilogram the person weighed. They wanted to see if more
people were able to reduce their dose to this level if they had adalimumab injections.
WHAT DOES THE NEW STUDY SAY?
At the end of the study, of the people who had adalimumab, 59 percent were taking the low corticosteroid dose and were in remission. Of the people who had a placebo injection, 50 percent were taking the low dose and were in remission. Most of the other people in the study needed to take a higher dose of corticosteroids.
However, because the study was quite small (70 people in total), the researchers said the difference in the results between the two groups was small enough that it could have been down to chance.
HOW RELIABLE ARE THE FINDINGS?
This was a randomised controlled study, which is one of the best ways to see whether a treatment works. The results are likely to be reliable for the dose of corticosteroids and adalimumab used. However, it’s possible that different doses or different schedules of injections might have shown a different result.
WHAT DOES THIS MEAN FOR ME?
This trial does not show a clear benefit for patients taking adalimumab in addition to corticosteroids for giant cell arteritis. But further studies in this area might have different results, so adalimumab might be found useful for some people with this condition in future.
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Date summary prepared: December 2014
Summary based on research article published on: 29 July 2013
From: Seror, R. et al. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis 2014;73:2074-2081 doi:10.1136/annrheumdis-2013-203586
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