The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of Sanofi’s Lemtrada (alemtuzumab), as well as cautioning users of Xeljanz (tofacitinib) that it could increase the risk of blood clots.
Firstly, the safety committee suggested restricting Lemtrada for use in adults with highly active relapsing remitting multiple sclerosis, despite adequate treatment with at least one disease-modifying therapy, or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.
It had also issued interim measures on the drug while reviewing reports of serious reactions. The committee then completed the review and recommended that Lemtrada must no longer be used in in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.
Xeljanz, Pfizer’s rheumatoid arthritis, psoriatic arthritis and ulcerative colitis treatment, was cautioned or use in patients at high risk of blood clots. The committee found that in addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk unless there is no suitable alternative treatment.
Patients older than 65 years of age should also be treated with Xeljanz only when there is no other appropriate treatment.
The new recommendations follow the PRAC’s review of an ongoing study in patients with rheumatoid arthritis and an increased risk of cardiovascular disease, which showed an increased risk of blood clots in deep veins and in the lungs with both the 5 mg and 10 mg twice daily doses of Xeljanz as compared with patients taking TNF-inhibitors.