EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.
In the EU, 5 mg twice daily is the authorised dose for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis.
EMA is assessing the early results and will consider if any regulatory action is needed. In the meantime, patients with rheumatoid arthritis who are receiving Xeljanz at 10 mg twice daily in study A3921133 will have their dose reduced to 5 mg twice daily for the remaining duration of the study.
The aim of the study was to look at the risks of heart and circulatory problems with Xeljanz in patients 50 years of age or older who were already at higher risk of these, and to compare its safety with that of another medicine called a TNF inhibitor.
While full results are awaited, EMA is recommending that healthcare professionals monitor patients for signs and symptoms of blood clots in the lungs. Patients should not stop or change their dose of Xeljanz without talking to their doctor. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood.
Healthcare professionals are being informed in writing of the preliminary results of the study and the current treatment recommendations.
There are other ongoing clinical trials in the EU with Xeljanz at a dose of 10 mg twice daily. Patients taking part in clinical trials with Xeljanz should speak to the doctor giving it to them if they have any questions or concerns.
Xeljanz is authorised to treat adults with moderate to severe rheumatoid arthritis (a disease that causes inflammation of the joints) and psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints). In these indications, Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
In patients with rheumatoid arthritis, Xeljanz can also be used alone in patients who cannot take or are intolerant to methotrexate.
Xeljanz is also authorised to treat adults with moderate to severe ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects.
