Jyseleca

Jyseleca is available as tablets to take by mouth.

The usual dose is 200 mg once daily. Treatment with Jyseleca is only started if blood tests show that the levels of haemoglobin (the protein in blood that carries oxygen) and certain white cells are above a set limit. The doctor may interrupt treatment if the levels drop below the set limit. Treatment should be discontinued in patients with ulcerative colitis who have not shown an adequate benefit from the treatment in the first 22 weeks. Jyseleca can only be obtained with a prescription, and treatment should be started by a doctor experienced in treating rheumatoid arthritis or ulcerative colitis.

For more information about using Jyseleca, see the package leaflet or contact your doctor or pharmacist.

Filgotinib, the active substance in Jyseleca, reduces the activity of the immune system. It does this by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play an important role in the inflammatory processes that occur in rheumatoid arthritis and ulcerative colitis. By blocking the enzymes’ action, filgotinib can help to reduce symptoms of these diseases.

Rheumatoid arthritis

Three studies showed that Jyseleca was effective at improving symptoms by at least 20% in patients with moderate or severe rheumatoid arthritis.

The first study involved 1,755 patients whose condition was not controlled well enough with methotrexate. All patients continued to take methotrexate during the study. Symptoms improved after 12 weeks in 77% of patients taking Jyseleca 200 mg daily compared with 71% of patients treated with adalimumab (another rheumatoid arthritis medicine) and 50% of those receiving placebo (a dummy treatment).

The second study involved 448 patients whose condition was not controlled well enough with biological DMARDs (medicines made from living cells). All patients continued to take conventional DMARDs, with around 80% of them taking methotrexate. Symptoms improved after 12 weeks in 66% of patients taking Jyseleca 200 mg daily compared with 31% of those receiving placebo.

The third study involved 1,249 patients who had not previously taken methotrexate but were at a high risk of their disease worsening. Symptoms improved after 24 weeks in 81% of patients taking both Jyseleca 200 mg daily and methotrexate compared with 78% of those taking Jyseleca alone and 71% of those taking methotrexate alone.

Ulcerative colitis

One study in patients who had or had not been treated with a biological agent before showed that Jyseleca was effective at treating ulcerative colitis.

After 10 weeks of treatment, 26% of the patients who had not used biological agents before and were given Jyseleca experienced mild to no symptoms compared with 15% of patients given a placebo. Of the patients who had previously used biological agents, 11% of those taking Jyseleca had mild to no symptoms compared with 4% of patients who were given a placebo. After 58 weeks, 37% of patients taking Jyseleca daily had mild to no symptoms, compared with 11% of those given a placebo.

The most common side effects with Jyseleca (which may affect up to 1 in 10 people) are nausea (feeling sick), upper respiratory tract infection (nose and throat infection), urinary tract infection and dizziness.

Jyseleca must not be used in patients with active tuberculosis or other serious infections. It must also not be used during pregnancy.

For the full list of side effects and restrictions of Jyseleca, see the package leaflet.

Studies have shown that Jyseleca alone or in combination with methotrexate is effective for treating moderate to severe rheumatoid arthritis when previous treatment with DMARDs had not worked well enough. They have also shown that it is effective for treating adult patients with moderately to severely active ulcerative colitis for whom conventional or biological treatments did not work or are not tolerated.

In general, the side effects of Jyseleca were similar to those of other medicines of its class, and the most important side effect is infection. There is also concern that it might reduce fertility in men. Specific warnings and information material are available to help manage these risks.

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

The company that markets Jyseleca will provide educational materials to healthcare professionals and patients about important risks with the medicine and the management of these risks. The information, including a patient alert card, is intended to increase awareness of the risk of serious infections, blood clots and serious conditions affecting the heart and circulation, harm to the baby during pregnancy and effects on men’s fertility.

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

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

Jyseleca received a marketing authorisation valid throughout the EU on 24 September 2020.