Tofacitinib (Xeljanz) for the treatment of ulcerative colitis

Introduction

Tofacitinib (trade name: Xeljanz) has been approved in Germany for the treatment of moderately to severely active in adults since August 2018. This medication is an option if previous treatments weren’t effective enough or weren’t well tolerated.

Ulcerative colitis is a chronic bowel disease in which the lining of the large intestine is constantly inflamed. This can cause diarrhea with blood and pus in it, pain in the lower left abdomen (belly) and fever. The condition often leads to weight loss.

It typically comes in episodes: There are acute phases with symptoms, and phases with fewer or no symptoms. During acute phases (also known as flare-ups or relapses), the symptoms may become so severe that they make it impossible to go to work or might even have to be treated at the hospital.

Ulcerative colitis is usually treated with medication. The type and the number of different medications used depend on the severity of the flare-ups. Surgery is an option if complications arise or if the disease is especially severe.

Treatment with tofacitinib aims to decrease the in the bowel by inhibiting a protein, thereby reducing the production of several chemical messengers that promote .

Application

One tablet contains either 5 or 10 mg of tofacitinib. For the first eight weeks, 10 mg of tofacitinib are taken twice a day in the form of tablets. After that, 5 mg of tofacitinib are taken twice a day. The dose can be adjusted based on any past treatments and the success of the treatment. If tofacitinib hasn’t had enough of an effect after 16 weeks, treatment should be stopped.

Other treatments

Various medications are used in moderately to severely active , to relieve the symptoms and reduce . If previous standard treatments were no longer effective enough or weren’t tolerated, medications produced using biotechnology (biological drugs, or biologics) can be used instead. These include TNFα inhibitors such as adalimumab, infliximab or golimumab.

If one of these TNFα inhibitors or another biologic such as an anti-integrin was not effective enough or wasn’t tolerated, switching treatment to another TNFα inhibitor or another anti-integrin such as vedolizumab may be an option.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether tofacitinib has any advantages or disadvantages in the treatment of moderately to severely active in adults when compared with the current standard treatments.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

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 the 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 (Colitis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commissio A18-52. November 28, 2018. (IQWiG reports; Volume 683).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on January 2, 2019
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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