In the EU, the higher dose of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis. The Agency is assessing the early results and will consider if any regulatory action is needed. In the meantime, patients with rheumatoid arthritis who are receiving 10 mg twice daily in the study will have their dose reduced to 5 mg twice daily for the remaining duration of the study. Healthcare professionals are advised to monitor patients for signs and symptoms of PE and patients should seek medical attention immediately if they experience symptoms