Researchers accused of etanercept “bias”

Medicines

25 Jan 2015

A industry sponsored study published late last year in the New England Journal of Medicine has been accused of being biased in favour of the anti-TNF etanercept.

In November last year Paul Emery and colleagues reported the results of the PRIZE trial, which suggested that for patients with early rheumatoid arthritis who achieved remission on full-dose etanercept plus methotrexate, continuing this combination treatment at a reduced dose controlled the disease better than methotrexate or placebo alone.

However, in a letter to the NEJM  Niels Gradual and Gesche Jürgens from the University of Copenhagen accused the study of being “inappropriately biased in favour of etanercept”. According to the researchers the study by Emery et al. published in the Nov 6 issue of the journal contravenes recommendations not to use biologic agents as first-line treatment for rheumatoid arthritis.

“Furthermore, the study uses biased control groups (methotrexate monotherapy and placebo) and does not compare the combination treatment (etanercept plus methotrexate) with a balanced combination of disease-modifying antirheumatic drugs (DMARDs),” they wrote.

In response Professor Emery and colleagues from the University of Leeds point out that the EULAR recommendations in 2010 –when the study started –stated that biologic agents could be used first in the case of severe disease. In 2013, the recommendations were modified to suggest that conventional synthetic DMARDs be used first.

“Graudal and Jürgens also indicate that a comparison with methotrexate monotherapy rather than with combination DMARDs biased the study. However, the 2013 EULAR recommendations do not endorse initial triple therapy but suggest initial methotrexate monotherapy, albeit plus glucocorticoids,” they wrote.

They point out that recommendations are not absolute rules and are based predominantly on clinical outcomes.

“The induction of remission at 1 year with biologic therapy and methotrexate has been shown to produce significant benefits 8 years later,” they concluded.

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