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Posted by on Feb 17, 2018 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study investigated the effectiveness of a new drug, LBEC0101, for the treatment of rheumatoid arthritis.

They found that LBEC0101 improved disease symptoms and was well tolerated by patients.

Some background

Rheumatoid arthritis (RA) is a chronic condition caused by the body’s immune system attacking tissue in the joints. This leads to inflammation and pain in the joints. Patients are prescribed medication to suppress the immune system, such as methotrexate (Trexall). However, some patients do not respond well to methotrexate. This is because the immune system is complex and as RA progresses some medications are less effective.


 Etanercept (Enbrel) is a treatment that blocks a protein called tumor necrosis factor alpha (TNF-α). LBEC0101 is a biosimilar of etanercept. A biosimilar is a treamtent very similar but manufactured by a different company. Whether LBEC0101 is as effective as etanercept is still under investigation. 


Methods & findings

This study investigated if LBEC0101 is as effective as etanercept at treating RA symptoms in patients that do not respond well to methotrexate.

This study included approximately 370 patients with RA. Patients were randomly assigned to 2 groups. They received 50 mg of LBEC0101 or etanercept once a week, subcutaneously (under the skin) for 52 weeks. Patients were evaluated for disease activity aft 12, 24 and 52 weeks.

Patients taking LBEC0101 had a similar improvement in disease activity scores as those taking etanercept. Adverse events were reported by 92% of patients taking LBEC0101 compared to 92.5% of etanercept users. Serious related adverse events were the same in both groups (7%). 

The bottom line

This study concluded that LBEC0101 was as effective as etanercept, and was well tolerated by patients.

The fine print

85% of the patients in this study were female. The study was conducted on an East Asian population so the results may not translate to other ethnicities. This is the first clinical report of this drug so long-term studies will be needed. 

What’s next?

If you have any concerns regarding rheumatoid arthritis treatment please discuss with your doctor. 

Published By :

Annals of the rheumatic diseases

Date :

Dec 19, 2017

Original Title :

Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to m

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