What is Olumiant and what is it used for?
Olumiant is a medicine used to treat rheumatoid arthritis (a disease that causes inflammation of the joints).
It is used in patients with moderate to severe arthritis, when the standard treatment with antirheumatic drugs - modifying the disease (also known as "DMARD") has not worked well enough or if patients cannot tolerate them. Olumiant can be used alone or in combination with methotrexate, a disease-modifying drug.
Olumiant contains the active substance baricitinib.
How is Olumiant - Baricitinib used?
Olumiant therapy should be initiated by a physician experienced in the diagnosis and treatment of rheumatoid arthritis. It is available as tablets to be taken orally. The usual dose is 4 mg once a day, but can be reduced to 2 mg once a day when the disease is under control. The dose may need to be reduced in patients with impaired renal function or an increased risk of infections and in those over 75 years of age or who are taking other medicines.
For more information, see the package leaflet.
The medicine can only be obtained with a prescription.
How does Olumiant - Baricitinib work?
The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation and joint damage that occurs in rheumatoid arthritis. By blocking the enzymes, baricitinib reduces inflammation and other symptoms of the disease.
What benefit has Olumiant - Baricitinib shown during the studies?
Three studies on approximately 2, 500 patients showed that Olumiant improves symptoms such as tenderness and swelling in the joints in patients where previous disease-modifying drugs did not work well enough. In these studies, Olumiant (alone or in combination with disease-modifying medicines such as methotrexate and adalimumab) resulted in more than 20% improvement in a standard symptom score (ACR 20) in more patients than in comparator medicines and to placebo. The results of the three studies after 12 weeks of treatment are the following:
- in patients previously treated with methotrexate, 70% of patients (339 of 487) receiving Olumiant achieved at least a 20% improvement in symptom scores compared to 61% of patients (202 of 330) treated with adalimumab and 40% (196 of 488 patients) of those receiving placebo;
- in patients previously treated with conventional disease-modifying drugs, 62% of patients (140 of 227) receiving Olumiant achieved an improvement of at least 20% compared to 40% of patients (90 of 228) treated with placebo;
- in patients previously treated with a class of disease-modifying drugs called TNF inhibitors, 55% of patients (98 of 177) receiving Olumiant achieved an improvement of at least 20% compared to 27% of patients (48 of 176) treated with placebo.
Olumiant has also been studied in patients who have not received any previous treatment. In a study involving 584 patients, Olumiant was more effective than methotrexate. However, long-term safety data are not available and therefore these results alone are not sufficient to support the use of Olumiant in previously untreated patients.
What are the risks associated with Olumiant - Baricitinib?
The most common side effects of Olumiant, used alone or in combination with methotrexate, were increased levels of blood cholesterol, nose and throat infections and nausea (may affect 2 or more people in 100). The infections reported with the Olumiant treatment also included shingles (shingles). For the full list of all side effects reported with Olumiant, see the package leaflet.
Olumiant should not be taken during pregnancy. For the full list of limitations, see the package leaflet.
Why has Olumiant - Baricitinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Olumiant's benefits are greater than its risks and recommended that it be approved for use in the EU.
The CHMP considered that Olumiant had shown to be effective in improving the symptoms of rheumatoid arthritis in patients in whom previous treatment with disease-modifying drugs had not worked satisfactorily or in patients who could not tolerate them. The CHMP also took into account the lack of therapeutic options for these patients and the fact that Olumiant is beneficial for patients since it can be administered orally. In terms of safety, being an oral treatment, Olumiant does not present the same risks as other DMARDs administered by injection, such as allergic reactions related to the way the medicine is administered. Overall, its side effects are considered manageable and several measures have been put in place to minimize the risks associated with this medicine, particularly infections.
What measures are being taken to ensure the safe and effective use of Olumiant - Baricitinib?
The company that markets Olumiant will ensure that the doctors who must prescribe the medicine receive an information packet on the risks associated with Olumiant, in particular the risk of infection, and on the monitoring to which patients must be subjected. Patients will be given a special alert card containing a summary of information on the safety of the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for Olumiant to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
Other information on Olumiant - Baricitinib
For the full EPAR of Olumiant, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Olumiant therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
