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More bad security news from Xeljanz

Another analysis of the mandatory post-marketing safety study of tofacitinib (Xeljanz) confirmed what most observers expected: higher rates of drug infection in rheumatoid arthritis than tumors Necrosis factor (TNF) inhibitor.

In a high-profile oral surveillance trial, the rate of infection with the JAK inhibitor tofacitinib in patients with rheumatoid arthritis was 71.2% to 72.5% (two doses were evaluated), compared to 64.1% using TNF inhibitors, according to Andra-Rodica Balanescu, MD, of the Carol Davila University of Medicine and Pharmacy in Bucharest, Romania, and colleagues.

Researchers report groundbreaking oral drug in Annals of Rheumatology .

A preliminary analysis of oral surveillance in 4,362 patients showed that tofacitinib was also associated with a higher risk of major cardiovascular events and malignancies, with rela being superior to TNF inhibitors. The drug’s label, updated last December, now warns of an increased risk for all three types.

Overall, given all the findings of oral monitoring, “these results should be used with caution in rheumatoid arthritis,” Balanescu and colleagues wrote. Clinical trial results issue a boxed warning. These indicate higher rates of infection and certain malignancies, but regulators want safety-focused trials to better manage risk.

Only rheumatoid arthritis patients 50 years of age and older who did not respond to methotrexate were eligible for the trial. Participants were also required to have at least one cardiovascular risk factor other than age, as assessing cardiovascular events was the primary Target. The mean age of patients was approximately 61 years, and for patients with rheumatoid arthritis, nearly 80% were women.

Patients were initially randomized to the same number of tofacitinib group, 5 or 10 mg twice daily, or placebo. However, an interim analysis in 2019 showed an increase in mortality in the high-dose group, and these patients were subsequently switched to a lower dose for the remaining scheduled treatment , thereby ending mortality in the high-dose group. (However, 10 mg twice daily is still the approved dose for some patients with ulcerative colitis.) For controls, North American participants were given adalimumab (Homere Le); etanercept (Enbrel) used elsewhere.

Most infections seen in the trial were non-severe upper respiratory disease; 12.8% to 12.8% in the tofacitinib arm Urinary tract infections occurred in 15.2% and 12.7% of the placebo group, with herpes zoster in 11.5% to 12.1% of the tofacitinib group and 3.8% of the placebo group.

tofacitinib group Serious infections occurred in 9.7% to 11.6% compared to 8.2% in the placebo group. Fatal infections occurred in 0.4% to 0.9% in the tofacitinib group compared to 0.3% in the placebo group. Participants who experienced multiple serious infections used Tofacitinib was also more common than placebo, as were cases of widespread shingles.

However, while tofacitinib’s labeling emphasizes that tuberculosis is a specific risk, Latency rates for both

Last September, when the FDA completed its analysis of oral surveillance data provided by Pfizer, it not only required new warning labels for drugs, but also limited eligibility criteria , including only those patients who failed TNF inhibitors.While safety studies only included patients with rheumatoid arthritis and cardiovascular risk factors, these limitations apply to all approved indications, which also include ankylosing spine inflammatory disease, juvenile idiopathic arthritis, psoriatic arthritis, and ulcerative colitis. Boxed warnings also appear on the labels of all other JAK inhibitors, such as baricitinib (Olumiant) and upadacitinib (Rinvoq).

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John Gever was Editor-in-Chief from 2014 to 2021; he is now a regular contributor.


Oral monitoring was funded and led by Pfizer.

Several authors are company employees. Co-authors report on relationships with numerous pharmaceutical companies, including Pfizer, and their competitors in the rheumatology space.



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