The drug tofacitinib (trade name: Xeljanz) has been approved in Germany since March 2017 for the treatment of moderate to severe rheumatoid arthritis in adults. It is an option if previous treatments weren't effective enough or weren't well tolerated.
In rheumatoid arthritis, several joints are permanently inflamed and may become deformed and stiff 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.
Tofacitinib belongs to a class of drugs that are used to reduce the inflammations and symptoms. They can be used on their own or in combination with methotrexate.
Tofacitinib is taken twice a day as a 5 mg tablet. It is combined with methotrexate. If methotrexate isn't an option, tofacitinib can also be used on its own.
In moderate to severe 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 treatments: those that help to stop the condition from getting worse (disease-modifying), and those that are designed to relieve the symptoms (symptomatic).
Patients are typically 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, adalimumab and tocilizumab. In severe rheumatoid arthritis, rituximab can be considered too.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether tofacitinib has any advantages or disadvantages for people with moderate to severe rheumatoid arthritis when compared with the current standard treatments.
The manufacturer provided data from two studies for the purpose of this comparison. The participants had already used methotrexate but it hadn't reduced their symptoms enough. Treatment with biological drugs was then considered. The researchers at IQWiG were able to use the data of about 1,070 patients in the analysis. Half of the patients received tofacitinib, and the other half had treatment with adalimumab. All of the participants received methotrexate as well. The following results were found after one year:
What are the advantages and disadvantages of tofacitinib?
- Tofacitinib wasn’t found to have any advantages or disadvantages compared to adalimumab.
- Rheumatoid arthritis remission: Remission means that the symptoms almost go away completely – for good, or at least temporarily. There was no difference here. In each of the groups, about 15 out of 100 people experienced a remission.
- Serious side effects: There was no difference here either. About 10 out of 100 people in each group had severe side effects.
- Treatment stopped due to side effects: About 10 out of 100 people in each group stopped the treatment due to side effects.
- There was also no difference between tofacitinib and adalimumab in terms of the following:
- Reduction in disease activity
- Number of joints that were painful to the touch or swollen
- Health-related quality of life
- General health
- Physical functioning
- Infections and serious infections
What remains unanswered?
- The manufacturer did not provide any suitable data in terms of sleep problems.
This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were 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 tofacitinib (Xeljanz).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Tofacitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-28. July 27, 2018. (IQWiG reports; Volume 652).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Tofacitinib (rheumatoid arthritis) – Addendum to commission A18-28. Commission A18-56. October 04, 2018. (IQWiG reports; Volume 673).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Tofacitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-18. July 28, 2017. (IQWiG reports; Volume 525 ).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Tofacitinib (rheumatoid arthritis) – Addendum to commission A17-18. Commission A17-43. September 28, 2017. (IQWiG reports; Volume 545).
IQWiG health information is written with the aim of helping
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