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June 27, 2024
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Upadacitinib’s risk-benefit profile in rheumatoid arthritis ‘favorable’ through 5 years

Fact checked byShenaz Bagha
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Key takeaways:

  • The initial clinical outcomes of upadacitinib for RA “improved or were maintained” through 5 years.
  • Major adverse cardiovascular events and venous thromboembolisms were infrequent.
Perspective from Gwendolyn Robinson, RN

The risk-benefit profile of upadacitinib for rheumatoid arthritis “remains favorable” through 5 years, according to data published in The Journal of Rheumatology.

In a long-term extension of the phase 3 SELECT-NEXT study, major adverse cardiovascular events, venous thromboembolisms and malignancies, other than non-melanoma skin cancer, “were reported infrequently” among those who received the drug, Gerd R. Burmester, MD, a professor of medicine at Charité-Universitätsmedizin Berlin, in Germany, and colleagues wrote.

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The risk-benefit profile of upadacitinib for RA “remains favorable” through 5 years, according to data. Image: Adobe Stock

“The Janus kinase inhibitors, upadacitinib, tofacitinib, baricitinib and filgotinib, are [targeted synthetic DMARDs] that have demonstrated efficacy for the treatment of RA, with acceptable safety profiles,” they added. “However, it is recommended that they are used with caution in patients who have an increased risk of major adverse cardiovascular event[s] (MACE). It is important to evaluate long-term safety data for JAK inhibitors, particularly events with typically low incidence.”

Gerd R. Burmester

In the initial trial, patients with RA were randomly assigned to receive either 15 mg or 30 mg of upadacitinib (Rinvoq, AbbVie) once daily, or placebo, for 12 weeks. Included participants must have had an inadequate response to conventional synthetic DMARDs. After 12 weeks, 92% of participants (n = 611) entered the long-term extension study, and those on placebo were randomly assigned to one of the treatment arms.

Participants remained blinded “until a protocol amendment due to the approval of the upadacitinib 15 mg dose for RA, after which all patients received open-label upadacitinib 15 mg,” the researchers wrote.

Overall, 44% of participants in the long-term extension study discontinued the drug by 5 years; 16% of those participants cited adverse events. The initial clinical outcomes “improved or were maintained” through 5 years, with similar results regardless of initial drug assignment, according to the researchers. From week 60 through 5 years, there were increasing proportions of patients achieving ACR20, ACR50 and ACR70 criteria responses.

A total of 29 malignancy events were recorded, most of which “were serious” and led to discontinuation, the researchers wrote. Major adverse cardiovascular events occurred at rates of 0 to 0.9 per 100 patient -years, while venous thromboembolism rates ranged from 0.3 to 0.5 per 100 patient-years.

“Upadacitinib continued to improve clinical outcomes in patients with RA who were csDMARDs-IR through 5 years,” Burmester and colleagues wrote. “Moreover, no new safety findings were identified during the LTE. Results remained consistent with earlier analyses of SELECT-NEXT. Overall, the long-term benefit–risk profile for upadacitinib in RA remains favorable.”