Rheumatoid arthritis patients who have stable and improved symptoms should continue long-term maintenance treatment on full- or low-dose etanercept.
INTRODUCTION
Rheumatoid arthritis is a chronic inflammatory disease that affects a person’s joints and sometimes their internal organs, causing pain and disability. Etanercept is one of a group of medicines called biologics that are used to treat rheumatoid arthritis. Etanercept works by targeting a particular molecule that is involved in causing inflammation. It is often given in combination with another drug called methotrexate.
WHAT DID THE AUTHORS HOPE TO FIND?
The authors wanted to see whether people with rheumatoid arthritis who had been taking methotrexate plus etanercept in combination for a long time with good results (stable low disease activity or remission) would be able to continue to do well if their medicine was changed. The medicine was changed to either methotrexate on its own, or methotrexate plus only half the dose of etanercept.
WHO WAS STUDIED?
The study included 91 adults with rheumatoid arthritis who had been receiving etanercept plus methotrexate weekly for at least 14 months. All patients in the study had done well on the combination treatment and were showing signs of their joints being improved (less swelling and pain), or being in remission (no clinical signs or symptoms of the disease).
HOW WAS THE STUDY CONDUCTED?
This was a randomised, double-blind trial, which means that patients were assigned by chance to one of three treatment groups to receive either the same dose of methotrexate and etanercept as they had been having before, or half the amount of etanercept plus methotrexate, or just methotrexate on its own. Using chance in this way means that the groups will be similar and will allow the variable or treatment under investigation to be compared objectively. During the treatment neither patients nor their doctors knew which group they were in.
WHAT WERE THE MAIN FINDINGS OF THE STUDY?
The study found that people did better if they continued on the combination of methotrexate and etanercept or half the dose of etanercept and methotrexate than if they took methotrexate alone. Some people had flares (disease worsening) when etanercept was withdrawn or reduced, but they were able to get better again once they started taking the drug again. These results are important because they support doctors in using lower doses of expensive biologic drugs in some patients if they achieve stable low disease activity or remission.
ARE THESE FINDINGS NEW?
No, there are other studies that have found similar results, including the PRESERVE trial,1 which looked at a much larger group of people. However, the patients in this study had more severe (worse) disease than those in PRESERVE.
HOW RELIABLE ARE THE FINDINGS?
There are some limitations which may affect how reliable the findings are. The study was conducted in a small number of patients over a short time, which may mean that it is not reflective of the long periods that rheumatoid arthritis patients take their medicines for. Also, the way the information was recorded before the study entry could have meant people had experienced disease worsening, but that it had not been reported – this would mean they were not stable on treatment and should not have been included in the study.
WHAT DO THE AUTHORS PLAN ON DOING WITH THIS INFORMATION?
These results will be shared with other doctors and academics to inform them of the findings. The authors are planning more studies, including a very large trial in newly diagnosed patients looking at treatment with biologics followed by a gradual reduction of the dose (the NORDSTAR trial).
WHAT DOES THIS MEAN FOR ME?
If you are doing well on treatment, you may have your dose reduced. This should be a shared decision between you and your doctor, and the reduction should be made gradually. This will help to save money as well as protecting you from any long-term side effects that may be related to the dose. However, it is important that you do not stop taking your medicine without talking to your doctor first. More studies will be needed to confirm these findings and to make clear recommendations to doctors.
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Date prepared: February 2016
Summary based on research article published on: 14 April 2015
From: van Vollenhoven, RF. et al. Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. Ann Rheum Dis 2016;75:52–58.doi: 10.1136/annrheumdis-2014-205726.
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ADDITIONAL REFERENCE
1 Smolen JS, et al. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet 2013;381:918–29.
