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Posted by on Aug 13, 2018 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study investigated if an infliximab (Remicade) biosimilar is safe and effective to treat rheumatoid arthritis.

They found that the infliximab biosimilar PF-06438179/GP1111 was similarly effective as standard infliximab and well tolerated.

Some background

Biosimilars are medicines that act in the same way as the original biologic drug. Biologic drugs include antibodies, are very expensive to produce, and can be an expensive treatment option. Biosimilars are typically less expensive. It is important to compare biosimilar medicines to their reference drug to ensure that they are equally effective and safe.

PF-06438179/GP1111 is an experimental biosimilar drug. Its reference drug is infliximab. Infliximab reduces a chemical that promotes inflammation, tumour necrosis factor (TNF). It is commonly prescribed to patients with moderate to severe rheumatoid arthritis (RA) that do not benefit from standard treatments, such as methotrexate.

It is unclear if PF-06438179/GP1111 is equally as safe and effective as infliximab for the treatment of RA.

Methods & findings

This study included 649 patients with RA unresponsive to methotrexate. Patients were randomly assigned to receive either PF-06438179/GP1111 (3 mg/kg) or infliximab (3 mg/kg) over 78 weeks. This study reports the results from the initial 30 weeks of this trial. A total of 566 patients completed the 30 weeks. Patients that did not respond to treatment by week 14 had their dose of either drug increased to 5 mg/kg. Disease activity was assessed at the beginning, during and end of the trial.  

At week 14, 62.7% of patients taking PF-06438179/GP1111? and 64.1% of patients taking infliximab reached a target reduction of 20% in disease activity. At week 30, the reduction in disease activity remained similar between both groups. The number and nature of side effects was similar in both groups.  Infections were commonly reported side effects.

The bottom line

The authors concluded that the infliximab biosimilar PF-06438179/GP1111 was similarly effective as standard infliximab and well tolerated.

The fine print

The results in this study are encouraging, however the long-term effectiveness and safety remain to be seen. A high percentage (80%) of the participants in this study were female. 

This study was funded by Pfizer, the manufacturer of PF-06438179/GP1111.

What’s next?

If you have any questions regarding biosimilars and rheumatoid arthritis please discuss these with your doctor.

Published By :

Arthritis Research & Therapy

Date :

Jul 27, 2018

Original Title :

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.

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