Introduction

Nintedanib (trade name: Ofev) has been approved in Germany since January 2015 for the treatment of idiopathic pulmonary fibrosis in adults.

Idiopathic pulmonary fibrosis, also known as cryptogenic fibrosing alveolitis, is a chronic lung disease. "Pulmonary" means lung, "fibrosis" means scarring, and "idiopathic" means that the cause is unknown. This disease causes the walls of the air sacs in the lungs to become increasingly thicker, and the lung tissue becomes stiff. As a result, the lungs can no longer absorb enough oxygen to pass into the bloodstream. The first signs of fibrosis, such as breathing difficulties during physical activity or a dry cough, often first arise when the disease is already at an advanced stage.

The aim of treatment with nintedanib is to slow down the progression of the disease by inhibiting various proteins in the lung tissue.

Application

Nintedanib is available as capsules, in two doses: 100 and 150 mg. The recommended dose is 150 mg every 12 hours. The capsules should be taken with a meal. If this dose isn't well tolerated, it can be reduced to 100 mg every 12 hours. If the reduced dose isn't tolerated either, the treatment is stopped.

Other treatments

The standard treatment for mild to moderate idiopathic pulmonary fibrosis in adults is the drug pirfenidone or supportive treatment (best supportive care, or BSC). BSC is tailored to the patient's individual needs. It aims to relieve symptoms such as pain and improve quality of life.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of nintedanib compared with the standard treatments for people with idiopathic pulmonary fibrosis.

The data of 1,344 patients (taken from four studies) was analyzed. A total of 779 patients were given nintedanib and 565 people were given a placebo. All of the study participants also received best supportive care.

What advantages does nintedanib have?

Severe acute breathing difficulties (exacerbations): The studies found that nintedanib has an advantage here: Nearly 2 out of 100 people who took nintedanib had this symptom, compared to 6 out of 100 people in the placebo group.

What disadvantages does nintedanib have?

Gastrointestinal problems: The studies showed that nintedanib has a disadvantage compared to placebo treatment in terms of gastrointestinal (stomach and bowel) problems such as diarrhea: About 76 out of 100 people who took nintedanib had these side effects, compared to only 40 out of 100 people who received a placebo.

No difference

Life expectancy: No difference was found here. About 2 to 10 out of 100 people in each group passed away.

Change in breathing difficutlies and health-related quality of life: No significant difference was found here.

No difference was found regarding the following aspects either:

  • Physical fitness
  • The need for treatment with oxygen
  • Coughing
  • Breathing problems
  • General health
  • Severe side effects
  • Treatment stopped due to side effects

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 nintedanib (Ofev).