According to a recent press release, AbbVie’s upadacitinib (ABT-494), a JAK1 selective inhibitor currently being investigated to treat rheumatoid arthritis, has shown positive results in a Phase 3 trial.
New Study: AbbVie’s RA Monotherapy Shows Promise
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Results of this SELECT-MONOTHERAPY study show that upadacitinib met all primary and the key secondary endpoints. It was significantly better than methotrexate with a response of ACR (American College of Rheumatology Response Criteria) 20/50/70 achieved by 68%/42%/23% of patients who received 15mg and 71%/52%/33% of patients who received 30mg of upadacitinib compared with 41%/15%/3% of methotrexate patients at Week 14.
In addition, clinical remission was achieved by 28% with 15mg and 41% with 30mg vs. 8% with methotrexate. There was, however, a death in the low-dose arm, which brings the Phase 3 trial total to three deaths. Low disease activity was achieved by 45% and 53% of patients in the 15mg and 30mg groups compared to the 19% of patients who continued on methotrexate. Methotrexate is a common therapy for rheumatoid arthritis, but some patients do not respond to it or cannot tolerate it.
“The safety profile of upadacitinib was consistent with previously reported Phase 3 studies, with no new safety signals detected,” the press release stated.
“The positive results from the SELECT-MONOTHERAPY study are encouraging, as they are the first evidence to support the potential of upadacitinib as a therapy without the need for background methotrexate,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie, said in the release.
“These findings add to the growing body of data showing the potential for upadacitinib as a meaningful treatment option for patients suffering from rheumatoid arthritis. We look forward to sharing additional data from the upadacitinib Phase 3 rheumatoid arthritis program with the scientific community in 2018.”
This therapy has not been approved by regulatory authorities yet, and its safety and efficacy is still being established. AbbVie headquartered in North Chicago, Illinois, is a global, research-driven biopharmaceutical company that focuses on four primary therapeutic areas: immunology, oncology, virology and neuroscience.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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