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Posted by on Jul 3, 2016 in Rheumatoid Arthritis | 1 comment

In a nutshell

The study looked at the long-term risks associated with adalimumab (Humira) in patients with rheumatoid arthritis. The authors concluded that no additional long-term risks related to serious infections, response to vaccines or birth defects have been found.

Some background

In rheumatoid arthritis (RA), the immune system attacks the healthy joints the way it would a virus or bacteria. Adalimumab is a common biological drug used to treat RA. This drug works by blocking the activity of proteins that are known to contribute to the over-activation of the immune system.

Unfortunately, biological drugs can weaken the immune system of RA patients. As a result of a weakened immune system, RA patients can have a high rate of serious infections. Some biological drugs can reduce a patient’s response to vaccinations. Pregnancy outcomes must also be examined in patients receiving this treatments for long periods. Long-term negative side effects need to be monitored

Methods & findings

This study included records from 15,132 patients receiving adalimumab.

The most commonly reported negative side effects were serious infections. These included pneumonia, cellulitis (a bacterial infection of the skin), bacterial arthritis (arthritis brought on by a bacterial infection) and sepsis (when bacteria enter the blood stream).

Cases of moderate anaemia were lower in patients receiving adalimumab and methotrexate (Trexall, another treatment for RA).

Only 5% of patients on adalimumab had influenza infections after receiving an influenza vaccination compared to 14% of patients who did not receive the vaccination.

There were no increases in birth defects in patients receiving adalimumab compared to those who were not. 

The bottom line

The authors concluded that types of infection have not changed over time. No additional long-term risks have been discovered in this study since initial safety studies were carried out.

The fine print

This study did not compare the effects of adalimumab to other possible treatments. 

What’s next?

Consult with your physician regarding the treatment options available for rheumatoid arthritis.

Published By :

Annals of the rheumatic diseases

Date :

Jun 23, 2016

Original Title :

Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis.

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