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Upadacitinib Shows Positive Top-Line Results for Rheumatoid Arthritis

Developer AbbVie is planning global regulatory submissions later this year

A PPM Brief

Rheumatoid arthritis affects around 1.5 million people in the United States,1 and many patients still do not achieve clinical remission and relief.2  However, an ongoing study by AbbVie (North Chicago, IL) is evaluating upadacitinib, an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis. The company recently announced3 positive top-line results from its Phase 3 SELECT-COMPARE clinical trial on upadacitinib (15 mg, once daily), showing that the drug met the primary endpoints of the American College of Rheumatology 20% improvement criteria (ACR20) and clinical remission versus placebo after 12 weeks.

Following the 12-week treatment,3 71 percent of patients achieved an ACR20 response, compared with 36 percent of patients receiving placebo. In addition, patients receiving upadacitinib achieved ACR50 responses of 45 percent compared with 15 percent placebo, and ACR70 responses of 25 percent compared to 5 percent placebo. A significantly higher proportion of patients (29%) receiving upadacitinib achieved clinical remission (Disease Activity 28 [DAS28] C-Reactive Protein [CRP]) compared with placebo (6%). Additionally, low disease activity (LDA) based on the DAS28 (CRP) was seen in 45 percent of patients receiving upadacitinib compared to 14 percent receiving placebo.

Study findings also showed similar results and advantages of the drug over adalimumab, a similar medication for the treatment of rheumatoid arthritis, on secondary endpoints. Similar beneficial results were shown following 26 weeks of treatment, including significantly inhibiting radiographic progression.3

"We are excited by these strong results which add to the body of evidence that support the potential of upadacitinib to be an important treatment option for patients with rheumatoid arthritis," said Michael Severino, MD, executive vice president, research and development and chief scientific officer at AbbVie, in a press release.

Although upadacitinib is currently under review by regulatory authorities and its safety and efficacy has not been established, this clinical trial showed that the safety profile of the drug was consistent with previously reported results.3 Additional results of the SELECT-COMPARE clinical trial are to be presented at a future medical meeting and published in a peer-reviewed journal, according to AbbVie.3

Last updated on: April 12, 2018
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