Patients With Rheumatoid Arthritis Who Had Poor Response To Other Drugs Could Have Better Results With Golimumab
Editor's ChoiceMain Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 Jun 2009 - 0:00 PDT
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Over three million people in Europe and about 1.3 million in the US are affected by rheumatoid arthritis which is a chronic inflammatory disease. TNF-α inhibitors are frequently used to treat rheumatoid arthritis. But thirty to fifty percent of the patients receiving these drugs are intolerant to the therapy or have an inadequate response. These patients are usually treated with more than one TNF-α inhibitor. Yet, no controlled trial has examined information to establish whether patients who do not respond to one TNF-α inhibitor might gain from switching to another.
In order to find out more, Josef Smolen and his team undertook the GO-AFTER trial. They assessed the safety and efficacy of golimumab in patients with active rheumatoid arthritis who had been treated earlier with one or more TNF-α inhibitor (such as etanercept, adalimumab, or infliximab).
There were in total 461 patients recruited from eighty-two sites in ten countries. They received at random injections of placebo (155), 50mg of golimumab (153), or 100mg of golimumab (153) every four weeks for twenty four weeks. After fourteen weeks, patients were assessed to evaluate if they had reached a 20 percent or superior improvement. The American College of Rheumatology criteria for assessment of rheumatoid arthritis (ACR 20) was used.
The results indicated that considerably more patients receiving golimumab had achieved at least a 20 percent improvement in arthritis symptoms (ACR 20) than those on placebo. At week fourteen, 35 percent of patients on 50mg of golimumab and 38 percent of patients on 100mg of golimumab achieved ACR 20. Only 18 percent of patients receiving placebo achieved ACR 20.
An important fact was that among the 58 percent of patients who had discontinued previous TNF-α inhibitor treatment due to lack of effectiveness, 36 percent on 50mg golimumab and 43 percent on 100mg golimumab achieved ACR 20. Only 18 percent of patients on placebo achieved ACR 20.
After twenty four weeks, there was record of serious adverse events in 5 percent (14) of patients on 50mg golimumab, 4 percent (8) on 100mg golimumab, and 10 percent (15) of patients on placebo.
The authors explain: "Golimumab reduces the signs and symptoms of active rheumatoid arthritis and improves physical function in patients who had previously received TNF-α inhibitors, which suggests that switching patients from one TNF-α inhibitor to golimumab is effective and generally well tolerated."
In an associated note Yusuf Yazici from NYU Hospital for Joint Diseases in New York debates if these findings will change the way rheumatoid arthritis patients are treated. He concludes: "For those patients who have failed or had an inadequate response to etanercept, infliximab, adalimumab, or abatacept, golimumab might be a good option."
"Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial"
Josef S Smolen, Jonathan Kay, Mittie K Doyle, Robert Landewé, Eric L Matteson, Jürgen Wollenhaupt, Norman Gaylis, Frederick T Murphy, Jeffrey S Neal, Yiying Zhou, Sudha Visvanathan, Elizabeth C Hsia, Mahboob U Rahman, for the GO-AFTER study investigators
DOI: 10.1016/S0140-6736(09)60506-7
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Written by Stephanie Brunner (B.A.)
Copyright: Medical News Today
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