EMA committee recommends caution in use of tofacitinib owing to increased risk of blood clots

Recommendations say that 10mg maintenance doses of tofacitinib twice daily should not be used in patients with ulcerative colitis at high risk of blood clots.

EMA signage

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has endorsed recommendations that tofacitinib (Xeljanz; Pfizer) could increase the risk of blood clots in the lungs and should be used with caution in all patients already at high risk.

Tofacitinib is indicated for moderate-to-severe active rheumatoid arthritis (RA) in patients who have had an inadequate response to, or are intolerant to one or more disease-modifying anti-rheumatic medicines, as well as psoriatic arthritis and severe ulcerative colitis (UC).

The EMA has said that maintenance doses of 10mg twice daily should not be used in patients with UC who are at high risk of blood clots, unless there is no suitable alternative treatment. It also recommended that, owing to an increased risk of infection, patients aged over 65 years should only be treated with tofacitinib when there is no alternative treatment.

These recommendations follow a review of an ongoing study in patients with RA and an increased risk of cardiovascular disease, along with data from earlier studies and consultations with experts in the field.

At its meeting, held on 11–14 November 2019, the CHMP also endorsed recommendations to restrict the use of multiple sclerosis (MS) medicine alemtuzumab (Lemtrada; Genzyme) owing to reports of rare but serious side effects, including cardiovascular and immune-related disorders and deaths.

According to the committee, alemtuzumab should now only be used to treat relapsing–remitting MS if the disease is highly active despite treatment with at least one disease-modifying therapy, or if the disease is worsening rapidly.

The CHMP also recommended seven medicines for approval including siponimod (Mayzent; Novartis) for the treatment of adult patients with secondary progressive MS with active disease evidenced by relapses or inflammatory activity.

Last updated
The Pharmaceutical Journal, November 2019;Online:DOI:10.1211/PJ.2019.20207355