Olumiant

Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis. It is available as tablets to be taken by mouth. The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control. The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines. For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.

The medicine can only be obtained with a prescription.

The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis. By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.

Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough. In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo. The results of the three studies after 12 weeks of treatment are as follows:

• In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.

• In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
• In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177)  on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.

Olumiant has also been studied in patients who had not received previous treatment. In one study involving 584 patients, Olumiant was more effective than methotrexate. However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.

The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100). Infections reported with Olumiant treatment also included herpes zoster (shingles). For the full list of side effects reported with Olumiant, see the package leaflet.

Olumiant must not be used during pregnancy. For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Olumiant’s benefits are greater than its risks and it can be authorised for use in the EU.

The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them. The Agency also took into account the lack of treatment options for these patients and the fact that Olumiant can be given by mouth is convenient for patients. In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given. Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.

The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients. Patients will be given a special alert card that summarises the safety information about the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olumiant have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Olumiant is continuously monitored. Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.

Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.