Rheumatoid arthritis is an immune system disease causing swelling and damage in the joints. It affects between 0.5% and 1% of people in the EU. Patients with moderate to severe rheumatoid arthritis have chronic inflammation causing tiredness, pain and joint stiffness. The symptoms are reversible with suitable and proper treatment, joint damage and the related disability are permanent.
The European Medicines Agency (EMA) has suggested granting a marketing approval in the European Union (EU) for Olumiant (baricitinib) for the treatment of adults with mild to severe active rheumatoid arthritis. It is to be used to treat patients who have not responded effectively to, or who are incapable to endure one or more disease‑adapting anti-rheumatic drugs (DMARDs). Olumiant, which is taken by mouth, can be used on its own or in combination with methotrexate which is given by injection or infusion. However, even with the most effective treatments available, more than half of patients do not achieve a reasonable response so new treatment options are needed.
Olumiant works by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play a significant role in the method of immunity and inflammation that occurs in rheumatoid arthritis. By blocking these enzymes, Olumiant is expected to reduce the inflammation and other symptoms of the disease. It would be first JAK inhibitor to be used in the treatment of rheumatoid arthritis in the EU and offers a different mode of action to what is currently available.
The recommendation from EMA’s Committee for Medicinal Products for Human Use(CHMP) is based on results of four randomized controlled trials in 3,100 adults with moderate to severe active rheumatoid arthritis. One trial compared Olumiant to methotrexate, another compared Olumiant to adalimumab, and two compared Olumiant to placebo. Generally, Olumiant was more active at reducing disease activity in patients with moderate to severe rheumatoid arthritis, compared to those treated with methotrexate and adalimumab.
Olumiant showed efficacy in patients who had not responded to biologic DMARDs as well as in patients that had never been treated before. Maintenance of efficiency was demonstrated in 52-week-long trials.
The common side effects with Olumiant in clinical trials were:
- Increased lipid (fat) levels in the blood
- Upper respiratory tract infections
- Nausea
The opinion adopted by the CHMP at its December 2016 meeting is an intermediary step on Olumiant’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once a marketing authorization has been approved, a verdict on price and reimbursement will then take place at the level of each Member State considering the potential roleof the medicine in the context of the national health system of that country.
Dated: 16th’ December 2016