Introduction

The drug baricitinib (trade name: Olumiant) has been approved in Germany since January 2017 for the treatment of moderate to severe rheumatoid arthritis in adults. It is an option if previous treatments were not effective enough or were not well tolerated.

There are many different rheumatic diseases, but rheumatoid arthritis is probably the most common. In this condition, several joints are permanently inflamed and can become deformed and stiffen over time. Muscles also become weaker.

In advanced rheumatoid arthritis, stiff joints can make daily tasks difficult. Other symptoms such as pain and fatigue can be a big problem too.

In rheumatoid arthritis, various kinds of medication are used to relieve the symptoms, reduce the inflammation and to keep the joints working properly for as long as possible. There are two types of medications: those that treat the symptoms, and those that help to stop the condition getting worse.

To stop the progression of rheumatoid arthritis, patients are first given conventional disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, azathioprine, leflunomide, or sulfasalazine. If these conventional drugs are no longer effective enough, medications produced using biotechnology (biological drugs, or biologics) can be used instead. These include the drugs abatacept, etanercept, certolizumab pegol, golimumab, and tocilizumab.

Baricitinib belongs to a new class of drugs that are used to reduce the inflammation and symptoms. They can be used on their own or in combination with methotrexate.

Application

Baricitinib is available in the form of tablets, in two different doses (2 and 4 mg). The recommended dose is 4 mg per day, but can be reduced to 2 mg per day, depending on the patient's age and symptoms. The drug can be combined with methotrexate.

Other treatments

Depending on the course of the disease or previous treatments, patients with moderate to severe rheumatoid arthritis can use the following standard medications:

  • People whose condition is not expected to get worse, and who have had previous treatment with a single conventional DMARD that wasn’t effective enough, can switch to either a different conventional DMARD or to a combination of several conventional DMARDs.
  • People whose condition is expected to get worse, and who have had previous treatment with a single conventional DMARD (e.g. methotrexate or azathioprine) that wasn’t effective enough, can use biological drugs combined with methotrexate. If methotrexate isn’t well tolerated, the biological drug may be used on its own (monotherapy).
  • The combination of a biological drug and methotrexate is also an option for people who have had treatment with several conventional DMARDs that weren’t effective enough. If methotrexate isn’t well tolerated, the biological drug may be used on its own.
  • If a biological drug isn’t effective enough when used alone or in combination therapy, patients can switch to a different biological drug or – in more severe cases of rheumatoid arthritis – to rituximab.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of baricitinib compared with the standard treatments for adults with moderate to severe rheumatoid arthritis.

The manufacturer didn’t provide suitable data for people whose condition is not expected to get worse and who have had treatment with a single conventional DMARD that wasn’t effective enough. Similarly, no data was provided regarding people who had treatment with a biological drug that wasn’t effective enough when used on its own or in combination therapy. It is therefore not possible to determine whether the new drug baricitinib has any advantages or disadvantages for these people when compared to the standard treatments.

The manufacturer provided one study involving people who had moderate to severe rheumatoid arthritis. The study looked into the following two research questions:

  • How does baricitinib compare with the standard treatments for people whose rheumatoid arthritis is expected to get worse, and who have had treatment with a conventional DMARD that was used on its own and wasn’t effective enough?
  • How does baricitinib compare with the standard treatments for people who have had treatment with several conventional DMARDs that weren’t effective enough?

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More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of baricitinib (Olumiant).