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Posted by on Jan 4, 2016 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study looked at the effectiveness of tocilizumab (TCZ, Actemra) in patients with early rheumatoid arthritis (RA). The study concluded that TCZ is effective both on its own and combined with another drug, methotrexate (MTX, Trexall) in treating patients with RA.

Some background

Rheumatoid arthritis is a chronic autoimmune (the immune system attacks healthy tissue) disease that causes inflammation in the joints and joint deformity. Patients with early RA can benefit from early treatment. A first treatment option for many patients is MTX. However, some patients will continue to see disease progression.

TCZ blocks inflammation in the body. TCZ has been shown to be effective in patients who have progressed despite treatment with MTX. It is not clear whether TCZ is as effective in patients who have not yet been treated.

Methods & findings

This study examined the effectiveness of TCZ on its own and when combined with MTX.

1,162 patients with early RA were randomly put in four treatment groups. Group 1 received 4mg/kg of TCZ and MTX. Group 2 received 8mg/kg of TCZ and MTX. Group 3 received 8mg/kg of TCZ and a placebo (substance with no effect on the body). Group 4 received MTX and a placebo. Patients were treated for up to 52 weeks.

45% of group 2 and 39% of group 3 achieved remission (no evidence of disease activity) at 24 weeks, compared to 15% of group 4. At 52 weeks, 49% of group 2 and 20% of group 4 had achieved remission.

Group 2 showed significant improvements in physical function compared to group 4. Groups 1 and 3 were at least as effective as group 4 at 52 weeks. All doses of TCZ showed benefit compared to MTX alone. 

Serious adverse events were similar among groups. 20% of patients from group 2 had to withdraw from the study due to adverse events. The most frequent events leading to withdrawal included liver dysfunction and infection.

The bottom line

The study concluded that TCZ was effective and of benefit to patients with early and progressive RA. The results showed that the combinaton of 8mg/kg TCZ and MTX produced the best outcomes.

The fine print

The study had some limitations in that drug doses were modified, which may not be usual in practice.

What’s next?

If you have rheumatoid arthritis and require medication, you should discuss these results with your physician.

Published By :

Annals of the rheumatic diseases

Date :

Oct 28, 2015

Original Title :

Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial.

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