Biopharma AbbVie (ABBV) has announced positive Phase 3 data from a Select-Choice clinical trial, comparing Rinvoq (upadacitinib, 15 mg, once daily) to Bristol-Myers Squibb’s (BMY) Orencia (abatacept) in adults with moderate-to-severe active rheumatoid arthritis (RA).
The trial focused on patients with a prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs).
Rinvoq met the primary endpoint of non-inferiority versus Orencia on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12.
It also met the key secondary endpoints of superiority versus Orencia on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6.
This was the sixth and final Phase 3 study from the robust Select rheumatoid arthritis clinical trial program.
Rinvoq, Abbvie’s selective and reversible JAK inhibitor, was approved by both the FDA and Europe in 2019 for rheumatoid arthritis.
“Despite tremendous progress in the treatment of rheumatoid arthritis, about 70 percent of patients are still not achieving clinical remission with established therapies,” commented Michael Severino, M.D., vice chairman and president, AbbVie.
The results “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” he added.
The safety profile of Rinvoq was consistent with previously reported studies in rheumatoid arthritis, with no new safety risks detected. Through week 24, serious adverse events occurred in 3.3% of Rinvoq patients, compared to 1.6% of Orencia patients, the company said.
Shares in ABBV are currently trading up 6% year-to-date, and analysts have a bullish Strong Buy outlook on the stock with 8 recent buy ratings vs 2 hold ratings. The average analyst price target of $104 translates into 11% upside potential from current levels. (See ABBV stock analysis on TipRanks)
On June 2 Argus Resarch’s David Toung upgraded AbbVie to Buy with a $115 price target. He called the recent Allergan merger a meaningful catalyst, “diversifying [AbbVie’s] revenue and substantially expanding its product portfolio.”
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