AbbVie touts Rinvoq win in giant cell arteritis, potentially teeing up another label expansion

Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval when the agency endorsed it in Crohn's disease. After a new positive pivotal trial, the drug could be bound for another label expansion.

On Thursday, AbbVie said that Rinvoq, also known as upadacitinib, met its primary endpoint in the SELECT-GCA trial in patients with giant cell arteritis (GCA). Specifically, 46% of patients treated with the AbbVie drug at the 15 mg dose—plus a 26-week steroid taper regimen—achieved sustained remission from week 12 through week 52. 

As for patients on placebo and a 52-week steroid taper remission, the rate of sustained remission was 29% during that timeframe, AbbVie said in a release. Safety was consistent with the medicine's known profile.

"Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date commonly used with steroids," study lead investigator Daniel Blockmans, M.D., Ph.D., said in a statement.

Rinvoq did not meet any trial endpoints at the lower 7.5 mg dose.

Giant cell arteritis causes inflammation in medium and large arteries and usually affects people older than 50, according to AbbVie. The disease disproportionately affects women and causes patients to experience headaches, jaw pain and sudden vision changes, including loss of vision.

The other FDA-approved drug in GCA is Roche's Actemra. The FDA has approved Actemra biosimilars from Biogen and Fresenius Kabi in recent months, but those don't appear to have reached the U.S. market.

After AbbVie last year lost U.S. exclusivity for its stalwart immunology med Humira, Rinvoq is a key pillar in the company's business plan for the coming years. The company expects its newer immunology duo of Rinvoq and Skyrizi to pull down $27 billion by 2027, far eclipsing Humira's 2022 peak of $21 billion. 

Last year, the duo generated nearly $12 billion. The combined sales figure is expected to climb to $16 billion for 2024.

Rinvoq won its original FDA approval in 2019 and already carries the agency endorsements to treat seven diseases. AbbVie has said expansions into new disease areas will fuel growth in the years to come.

In the SELECT-GCA trial, Rinvoq also met its secondary endpoints of improving rates of complete remission and reducing disease flares.

AbbVie said it will share full trial results at an upcoming medical meeting.