Abatacept and methotrexate may work better at slowing the development of early-stage rheumatoid arthritis than methotrexate alone.
INTRODUCTION
Rheumatoid arthritis (RA) is a disease that causes inflamed (swollen) joints. The inflammation may eventually damage the cartilage and bone. Many doctors believe that there is a narrow ’window of opportunity’ to stop the progress of the disease when it has just started. It’s much harder to treat the disease when you have had it
for a while and the joints have been damaged.
Doctors prescribe disease-modifying anti-rheumatic drugs (DMARDs) to slow the development of RA and its effects on the joints. There are two types: conventional DMARDs and biological DMARDs. Biological DMARDs are a newer type of drug.
This research compared the effects of a conventional DMARD, methotrexate, with a newer biological drug, abatacept, on their ability to slow down the development of RA in people whose disease is still at an early stage.
WHAT DID THE RESEARCHERS HOPE TO FIND?
The study was paid for by Bristol-Myers Squibb, the maker of abatacept. The researchers wanted to find out whether abatacept – either alone or combined with methotrexate – worked better than methotrexate at improving people’s signs and symptoms of RA. In particular, they wanted to compare how many people went into
remission while they were taking the medicines – and how many people continued to be in remission six months after they stopped taking them. (‘Remission’ means that a person has few, if any, signs or symptoms of the disease.)
WHO WAS STUDIED?
The 351 people who took part in the study were adults (18 years and older) with early RA. None of the participants had reported having signs or symptoms of the disease for more than two years.
The people were selected from a number of centres in North and South America and Europe.
HOW WAS THE STUDY CONDUCTED?
The researchers randomly split the people into three groups. The first group was given abatacept and methotrexate (119 people). The second group was given abatacept on its own (116 people). And the third group was given methotrexate on its own (116 people).
After a year of treatment, the researchers looked at the people’s ‘disease activity score’ – a standard measure of how bad someone’s RA is. If people had a low score at this point, they stopped taking their RA medicines. The researchers then monitored them to see if their RA symptoms came back.
WHAT DOES THE NEW STUDY SAY?
The study found that taking abatacept and methotrexate together worked better than taking methotrexate alone. After a year of treatment, around 60 in every 100 people taking both drugs were in remission. This compared with about 45 in every 100 people taking methotrexate alone.
Abatacept alone and methotrexate alone were about as effective as each other. The study did not find any real differences in side effects between the two drugs. About 80 in 100 people in either group had side effects of some kind. These were not usually serious.
Six months after people stopped taking their RA medicines, nearly 15 in 100 of those who had taken abatacept plus methotrexate were still in remission. This compared with about 8 in 100 of those in the methotrexate group.
HOW RELIABLE ARE THE FINDINGS?
This was a type of study called a randomised controlled trial or RCT. This is the best way for testing how well treatments work. However, these findings show only what happened to the people six months after they stopped taking their treatments. So we do not know whether their RA continued to be in remission after that point.
WHAT DOES THIS MEAN FOR ME?
Different countries may have different criteria for use of abatacept. In general, abatacept is only recommended after failing conventional treatment, at least methotrexate . This study supports the use of abatacept in combination with methotrexate, but also indicates that stopping therapy even when you are in remission is associated with a rather high risk of relapse. If you want to know more about this treatment, you can talk to your rheumatologist
or rheumatology nurse specialist.
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Date summary prepared: January 2015
Summary based on research article published on: 3 November 2014
From: Emery, P. et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis 2015;74:19-26 doi:10.1136/annrheumdis-2014-206106
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