What is Olumiant - Baricitinib 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 standard treatment with disease-modifying antirheumatic drugs (also known as 'DMARDs') 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 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 daily when the disease is under control The dose may need to be reduced in patients with impaired kidney function or an increased risk of infections and in those over 75 years of age or 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 kinase. These enzymes play an important role in the 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 involving around 2,500 patients have shown that Olumiant improves symptoms such as painfulness and swelling in the joints in patients whose previous disease-modifying drugs have not worked well enough. In these studies, Olumiant (alone or in combination with disease-modifying medicines such as methotrexate and adalimumab) resulted in 20% or greater improvement in a standard symptom score (ACR 20) in more patients than the comparators and to 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) receiving Olumiant achieved an improvement of at least 20% in symptom scores compared with 61% of patients (202 out of 330) treated with adalimumab and 40% (196 out of 488 patients) of those receiving placebo;
- in patients previously treated with conventional disease-modifying drugs, 62% of patients (140 out of 227) receiving Olumiant achieved an improvement of at least 20% compared with 40% of patients (90 out of 228) treated with placebo;
- in patients previously treated with a class of disease-modifying drugs called TNF inhibitors, 55% of patients (98 out of 177) receiving Olumiant achieved an improvement of at least 20% compared with 27% of patients (48 out 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, no long-term safety data are available and these results alone are therefore 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 with Olumiant, used alone or in combination with methotrexate, were increased blood cholesterol levels, nose and throat infections and nausea (may affect 2 or more in 100 people). Infections reported with Olumiant treatment also included herpes zoster (St. Anthony's Fire). For the full list of side effects reported with Olumiant, see the package leaflet.
Olumiant must not be taken during pregnancy. For the full list of restrictions, 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 been 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 noted also taking into account the lack of treatment options for these patients and the fact that, being given orally, Olumiant is beneficial to patients. In terms of safety, being an oral treatment, Olumiant does not present the same risks as others. 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 minimize the risks associated with this medicine, especially infections.
What measures are being taken to ensure the safe and effective use of Olumiant - Baricitinib?
The company that markets Olumiant will ensure that doctors who are to prescribe the medicine receive an information pack about the risks associated with Olumiant, in particular the risk of infection, and the monitoring that patients should undergo. Patients will be given a special alert card containing a summary of the medicine's safety information.
The recommendations and precautions to be observed by healthcare professionals and patients for Olumiant to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.
Other information about Olumiant - Baricitinib
For the full version of Olumiant's EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Olumiant therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
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