Introduction

Tofacitinib (trade name: Xeljanz) has been approved in Germany for the treatment of moderately to severely active ulcerative colitis 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 inflammation in the bowel by inhibiting a protein, thereby reducing the production of several chemical messengers that promote inflammation.

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 ulcerative colitis, to relieve the symptoms and reduce inflammation. 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 ulcerative colitis 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).