StemCell Therapy

Pfizers Xeljanz, an oral JAK (Janus kinase) inhibitor rheumatoid arthritis treatment, has failed to catch up with the TNFi (tumor necrosis factor inhibitor) during a post-marketing study, reigniting the debate over its safety.

The post-marketing safety study, dubbed ORAL Surveillance, compared the safety of taking 5mg and 10mg of Xeljanz twice daily with TNFi in about 4,300 patients with rheumatoid arthritis aged 50 years or older with at least one cardiovascular risk factor.

The company set a co-primary endpoint of the study as the non-inferiority of Xeljanz compared to TNFi regarding major adverse cardiovascular events (MACE) and malignancies, excluding non-melanoma skin cancer. The results showed that the company failed to meet the prespecified non-inferiority criteria for the co-primary endpoints.

Analyzing 4,362 subjects, the number of patients with significant cardiovascular events was 135 (98 in the Xeljanz group and 37 in the TNFi group), and that of patients with malignant tumors was 164 (122 in the Xeljanz group and 42 in the TNFi group).

As Xeljanz failed to provide evidence that it was not inferior to TNFi in both cardiovascular and cancer risk, local industry officials expressed concerns that the U.S. Food and Drug Administration may put further restrictions on the drug or pressure the company to withdraw the drug from the market.

In 2019, the FDA had slapped a boxed warning on Xeljanz 10 mg's product label, cautioning against a higher risk of pulmonary embolism, a blood clot in the lungs that can be fatal. The European Medicines Agency also followed a few months later with a warning that patients with a high risk of blood clots should take caution with any dose of Xeljanz.

"Full study results, beyond the co-primary endpoints, including, but not limited to, secondary endpoints such as pulmonary embolism and mortality as well as efficacy data, are not yet available," Pfizer said. "We are working with the FDA and other regulatory agencies to review the full results and analyses as they become available."

Pfizer's study has also raised safety issues for other JAK inhibitors -- Lily's Olumiant and Abbvie's Rinvoq.

All JAK inhibitors publish boxed warnings regarding the occurrence of this blood clot on their product labels.

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Safety debate reignited over Pfizer's arthritis treatment Xeljanz - Korea Biomedical Review

This entry was posted on February 3, 2021 at 8:48 pm and is filed under Arthritis. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |