Introduction

Apremilast (trade name: Otezla) has been approved in Germany since April 2020 for the treatment of oral aphthous ulcers (aphthae, canker sores) in adults with Behçet’s disease. It is an option for patients who are able to have systemic treatment.

Behçet’s disease causes inflammation in the blood vessels, especially the smaller blood vessels in the skin and mucous membranes, eyes, joints and (less commonly) nerve tissue. The typical signs include open sores in the mouth and genital region, as well as eye inflammations.

The open sores in the mouth are called aphthous ulcers: The lining of the mouth is inflamed and has a reddish-white color. Aphthous ulcers can be very painful. They typically heal on their own within a few days, but often come back later.

Apremilast is supposed to reduce the inflammation of the mucous membranes by inhibiting a specific protein.

Application

Apremilast is available in the form of tablets, in the doses 10 mg, 20 mg and 30 mg.

The recommended dose is 30 mg of apremilast twice a day. The two doses should be taken twelve hours apart.

At the start of the treatment, 10 mg of apremilast is taken twice a day. This dose is then gradually increased to 30 mg twice a day over a period of roughly five days.

Other treatments

There are various other treatment options for oral aphthous ulcers in people who have Behçet’s disease, including dapsone, azathioprine, ciclosporin, interferon alpha, tumor necrosis factor (TNF) alpha inhibitors and thalidomide. The treatment is individually adjusted by the doctor.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether apremilast has any advantages or disadvantages compared to the standard treatment for oral aphthous ulcers in adults who have Behçet’s disease.

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 apremilast (Otezla).