MHRA Updates Safety Information On Tofacitinib

Pavankumar Kamat

October 07, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update for tofacitinib (Xeljanz) stating that individuals aged >65 years, current or past smokers or individuals with other cardiovascular or malignancy risk factors should not receive the drug unless no other appropriate treatment alternatives are available.

A large, randomised safety trial of tofacitinib (A3921133) in patients with rheumatoid arthritis aged ≥50 years with at least one cardiovascular risk factor showed an increased risk of major adverse cardiovascular events (MACE; HR for all doses of tofacitinib combined, 2.20; 95% CI, 1.02-4.75) compared with tumour necrosis factor (TNF)-alpha inhibitors, such as etanercept or adalimumab.

Risk factors for MACE included age >65 years, male sex, current or past smoking, history of diabetes and history of coronary artery disease (including prior myocardial infarction, coronary heart disease, stable angina pectoris or coronary artery interventions).

The same trial also found an increased risk of malignancies (non-melanoma skin cancer not included in the analysis), especially lung cancer and lymphoma, with tofacitinib vs TNF-alpha inhibitors (HR for all doses of tofacitinib combined, 1.48; 95% CI, 1.04-2.09). Risk factors for malignancies (excluding non-melanoma skin cancer) included age >65 years and current or past smoking.

Earlier in 2018, the A3921133 trial had highlighted the risks of venous thromboembolism and serious and fatal infections associated with tofacitinib.

Although the incidence of MACE and malignancies was small, health care professionals should discuss these risks with the patients.

This article originally appeared on Univadis, part of the Medscape Professional Network.


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