Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Medicines licensing

EMA recommends approval for oral rheumatoid arthritis drug

Baricitinib has been recommended for adults with moderate-to-severe disease who have shown intolerance or have not responded to at least one anti-rheumatic drug.

Arthritic hands of an older patient

Source: Shutterstock

Trials have shown that baricitinib was more effective in patients with rheumatoid arthritis compared with methotrexate and adalimumab

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that baricitinib (Olumiant; Eli Lilly), an oral therapy for rheumatoid arthritis (RA), is granted a marketing authorisation in the EU.

Unlike biologic therapies for RA, which consist of large proteins that must be delivered by injection or infusion, baricitinib is a small molecule drug that can be administered orally.

The drug, which is taken alone or in combination with methotrexate, reversibly inhibits two of the four known JAK enzymes. These enzymes are activated when cytokines bind to cell-surface receptors and many mediators involved in autoimmune inflammation, including some interleukins and interferons, signal via the JAK family in this way.

Responses to RA therapies vary greatly between patients and only around half achieve a satisfactory response under existing therapies. As such, Olivia Belle, director of external affairs at charity Arthritis Research UK, says there is a need to get new treatments to patients as quickly as possible.

“Delays in accessing effective treatments can cause frustration and increase the risk of joint damage and long-term disability,” she says.

“It’s important that we continue to discover and develop new treatment therapies so we can get the right treatment to the right patient at the right time, helping more people with rheumatoid arthritis push back the limits of arthritis.”

The CHMP’s opinion was based on data from four randomised controlled trials involving a total of 3,100 adults with moderate-to-severe active RA. Two trials compared baricitinib with placebo, one compared it with methotrexate and another with adalimumab (Humira; Abbvie), an injectable monoclonal antibody.

All four trials showed that baricitinib was more effective at reducing disease activity compared with methotrexate and adalimumab. In placebo-controlled trials, the drug showed efficacy in patients who had not responded to biologic disease-modifying anti-rheumatic drugs as well as in treatment-naive patients.

The most common side effects reported in the trials were increased blood lipid levels, upper respiratory tract infection and nausea.

The CHMP recommendation indicates that baricitinib is used in adults with moderate-to-severe RA who have had an inadequate response or are intolerant to at least one disease-modifying anti-rheumatic drug. It will be available at doses of 2mg and 4mg.

The approval would make it the first JAK inhibitor to be licensed for RA in the EU. The condition results in chronic inflammation leading to irreversible joint damage, joint pain and stiffness, and fatigue.

Another JAK inhibitor for RA, tofacitinib (Xeljanz; Pfizer), is marketed in 45 countries including the United States, but was denied marketing authorisation in 2013 by the EMA, which cited “major concerns” over the treatment’s safety profile.

The EMA’s concerns relate to the risks of serious infection resulting from immunosuppression, as well as concerns about the risk of certain cancers and gastrointestinal perforations, which the CHMP said it was not clear could be managed in clinical practice.

Pfizer refiled is application for tofacitinib to the EMA earlier in 2016 with additional clinical trial and open-label data.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20202123

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Pharmaceutical Statistics

    Pharmaceutical Statistics

    This book on basic statistics has been specifically written for pharmacy students.

    £33.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Arthritic hands of an older patient

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.