Issue: April 2024
Fact checked byShenaz Bagha

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February 13, 2024
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Baricitinib for RA exhibits long-term efficacy, low discontinuation due to adverse events

Issue: April 2024
Fact checked byShenaz Bagha
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Key takeaways:

  • One-fifth of baricitinib-treated patients discontinued due to adverse events or death over about 6.5 years.
  • The most common reason was sponsor’s decision due to fulfillment of study objectives.

Daily baricitinib, either 4 mg or 2 mg, demonstrates up to 6.5 years of efficacy with low rates of discontinuation due to adverse events in patients with rheumatoid arthritis, according to data published in Rheumatology.

“The long-term safety of baricitinib has been demonstrated,” Roberto Caporali, MD, of the University of Milan, and colleagues wrote. “However, as RA is a chronic disease with some patients receiving therapy for decades, it is important to understand not only the safety profile of a particular treatment but also the discontinuation rates and efficacy over the longest duration possible.”

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Bariticinib treatment for RA demonstrated up to 6.5 years of efficacy, with low rates of discontinuation due to adverse events. Image: Adobe Stock

To evaluate the long-term efficacy and discontinuation rates of daily baricitinib (Olumiant, Eli Lilly & Co.), Caporali and colleagues analyzed up to 6.5 years of data from three completed phase 3 studies, as well as a long-term extension study that included patients from each study. Those studies — RA-BEAM, RA-BUILD and RA-BEACON, plus the long-term extension RA-BEYOND — had reported the efficacy and safety of baricitinib in patients with an inadequate response to methotrexate, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biologic DMARDs.

Each group of patients underwent completer and non-responder imputation analyses up to either week 340 or 336 of the extension study — roughly 6.5 years — depending on which of the phase 3 studies they had originally been enrolled in.

Over that time, adverse events, death or lack of efficacy were the cause of fewer than one-fifth of baricitinib discontinuations in the extension study, according to the researchers. The most common reason for baricitinib discontinuation was the decision of a sponsor after a patient had fulfilled study objectives.

In addition, numerically greater proportions of patients treated with baricitinib from all groups achieved low disease activity at 6.5 years vs. those treated with placebo. Among patients with an inadequate response to methotrexate, 37%, 34% and 32% of those initially treated with baricitinib 4 mg, adalimumab or placebo, respectively, achieved low disease activity by week 340. In patients with an inadequate response to conventional synthetic DMARDs, 35%, 34% and 33% of those initially treated with baricitinib 4 mg, baricitinib 2 mg or placebo, respectively, achieved low disease activity at week 336.

In patients with an inadequate response to biologic DMARDs, 23%, 23% and 21% of those initially treated with baricitinib 4 mg, baricitinib 2 mg or placebo, respectively, achieved low disease activity at week 336.

During the extension study, the overall discontinuation rate was 72% among those with inadequate response to methotrexate, 61% among those with inadequate response to conventional synthetic DMARDs and 67% among those with inadequate response to biologic DMARDs.

“These results demonstrated the long-term efficacy of baricitinib 4 mg and 2mg in patients with RA for up to 6.5 years of treatment,” Caporali and colleagues wrote. “Low rates of discontinuation due to [adverse events], death and lack of efficacy indicated that baricitinib 4 mg treatment was both efficacious and well-tolerated over the long term.”