Phase 3 Trial Finds AbbVie’s Rheumatoid Arthritis Drug Effective

June 12, 2020 - AbbVie recently announced new Phase 3 clinical trial data, showing that RINVOQ (upadacitinib) was effective in adult patients with moderate to severe active rheumatoid arthritis.

SELECT-CHOICE, a randomized, double-blind study evaluated the safety and efficacy of upadacitinib in adult patients with active rheumatoid arthritis who had no response to or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs). 

SELECT CHOICE is the sixth and final Phase 3 study for the rheumatoid arthritis clinical trial program, AbbVie said.  

Participants were either given 15 mg of upadacitnib once daily or intravenous ORENCIA (abatacept). The primary endpoint was change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12.

Upadacitinib met the primary endpoint of non-inferiority versus abatacept from baseline at Week 12. The drug met secondary endpoints as well. 

The change from baseline in DAS28-CPR at Week 12 was -2.52 versus -2.00 in patients treated with abatacept. And while just 13 percent of patients receiving abatacept achieved clinical remission, 30 percent of upadacitinib patients showed the same. 

"Despite tremendous progress in the treatment of rheumatoid arthritis, about 70 percent of patients are still not achieving clinical remission with established therapies," Michael Severino, MD, vice chairman and president, AbbVie, said in the announcement. 

"We are pleased with the results as they add to our growing body of evidence that RINVOQ may offer more adult patients with rheumatoid arthritis a better chance at achieving clinical remission, including those who have already failed a prior biologic."

Upadacitinib is a selective and reversible JAK inhibitor discovered and developed by AbbVie. The drug is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to or who are intolerant to one or more DMARDs, Abbvie stated.

Researchers noted that the safety profile of upadacitnib 15 mg was consistent with that observed in previous studies in rheumatoid arthritis. No new safety risks were found.

Serious adverse events occurred in 3.3 percent of patients in the upadacitnib group, compared to 1.6 percent of patients in the abatacept group through Week 24.

Despite this, the American College of Rheumatology 20/50/70 responses were greater in the upadacitnib group compared to the abatacept group at 76, 46, and 22 percent versus 66, 34, and 14 percent, respectively, at Week 12. 

Improvements in disease activity and remission rates were maintained through week 24, researchers said.

"These data show that upadacitinib was superior to abatacept with regard to the proportion of patients achieving remission," said Andrea Rubbert-Roth, MD, professor, deputy director, division of rheumatology, Cantonal Hospital St. Gallen, Switzerland. 

"SELECT-CHOICE represents the first head-to-head study in rheumatoid arthritis patients who have failed biologic DMARDs and compares upadacitinib to a different biologic DMARD. Studies like this are important for daily decision-making in practice."

In mid-April, Eli Lilly and Company’s oral JAK1/JAK2 inhibitor was being tested in the National Institutes of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 treatment clinical trial. 

Baricitinib, marked as Olumiant, is approved in more than 65 countries as a treatment for adults with moderate to severe active rheumatoid arthritis. 

Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity may have potentially beneficial effects against the virus and warrants further study in infected patients.

“There is an urgent need for new strategies to help hospitalized COVID-19 patients, many of whom will progress to respiratory failure,” Vincent C. Marconi, MD, professor of medicine and global health at Emory University School of Medicine, one of the U.S. sites for NIAID's ongoing COVID-19 Treatment Trial, said in the announcement. 

“This NIAID study presents an important opportunity to test whether baricitinib can help these patients.”

The clinical trial began in April with planned expansions in Europe and Asia. Results are expected within the next few months.