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Posted by on Jul 28, 2014 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study examined the safety and efficacy of a tocilizumab (Actemra) injection in rheumatoid arthritis.

Some background

Rheumatoid arthritis is an autoimmune disorder, meaning the body’s immune system begins attacking healthy tissue in the same way it attacks bacteria or viruses. The main treatment for rheumatoid arthritis is to block the immune response with therapies such as disease-modifying antirheumatic drugs and tumor-necrosis factor (TNF) or interleukin-6 inhibitors, each of which inhibit a different aspect of the immune response.

Tocilizumab (Actemra) is an interleukin-6 inhibitor which has been found to be an effective rheumatoid arthritis therapy, both when used alone or in combination with disease-modifying antirheumatic drugs. This drug was originally developed to be delivered through an intravenous infusion (an IV). Recently, the Food and Drug Administration approved tocilizumab delivered through a subcutaneous injection, or vaccine (shot) through the skin. Injection treatments are often preferred by patients over intravenous infusions. The current study examined safety and efficacy of injected tocilizumab in rheumatoid arthritis patients who did not respond to disease-modifying antirheumatic drugs.

Methods & findings

In this study, 438 subjects received weekly injections of tocilizumab and 218 patients received weekly injections of a placebo (a substance that has no effect on the body used as a comparison) for 24 weeks. Patient response was measured with the American College of Rheumatology 20, a measure of the percentage of improvement seen with a treatment (the 20 refers to a 20% improvement in symptoms).

A 20% improvement in symptoms was seen in 60.9% of the subjects receiving tocilizumab, compared to 31.5% of patients receiving placebo. A 50% improvement was seen more often in patients receiving tocilizumab than placebo (a 27.9% difference between the two groups), as was a 70% improvement (a 14.8% difference).

Adverse events were experienced by 62.7% of patients receiving tocilizumab and 57.8% of placebo. The events were most often infections, such as upper respiratory tract infections. Three patients died during the study due to infections and complications due to infections. Each of these patients received tocilizumab. 11.6% of patients receiving tocilizumab and 3.7% of placebo patients reported neutropenia, a low white blood cell count that increases the risk of infection.

The bottom line

This study concluded that a subcutaneous injection of tocilizumab was a safe and effective treatment for rheumatoid arthritis in patients who had progressed despite treatment with disease-modifying antirheumatic drugs.

The fine print

This study, however, does not directly compare the injection and the intravenous infusion of tocilizumab, therefore it is impossible to tell which is more effective at improving symptoms.

This study was funded by Roche, the manufacturer of tocilizumab.

Published By :

Arthritis Care & Research

Date :

Jun 18, 2014

Original Title :

Subcutaneous Tocilizumab vs Placebo in Combination With Disease Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis.

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