AbbVie's Rinvoq is delivering blockbuster sales and driving growth for the drugmaker after its January loss of exclusivity for top-selling Humira. Now, Rinvoq is taking a step toward another potential label expansion.
In a phase 2 trial in systemic lupus erythematosus (SLE), AbbVie's immunology star—either on its own or as part of a combination—met its primary and key secondary endpoints, the company said Wednesday. The SLEek study tested the drug in adults with moderate to severe active systemic lupus erythematosus who also stayed on other standard therapies.
The trial tested Rinvoq at the 30 mg dose either on its own or with the investigational BTK inhibitor elsubrutinib. The combination treatment was codenamed ABBV-599.
After 24 weeks, both treatment arms met the study's primary endpoint of helping patients based on the SLE responder index—while reducing steroid usage requirements—compared with the placebo. The index looks at reductions in SLE disease activity.
On secondary endpoints, patients experienced fewer lupus flares and a longer time to first flare in both treatment arms, AbbVie said. The drugs met other measures of disease activity and treatment response, including on the Lupus Low Disease Activity State measure.
Investigators are presenting the detailed results at the European Congress of Rheumatology' EULAR 2023 meeting.
Back in March, AbbVie said the trial had met its primary endpoint and that it was advancing Rinvoq into late-stage testing in this indication.
As for ABBV-599, the company is not advancing the prospect into phase 3 studies based on its finding of "no additional contribution of efficacy by elsubrutinib relative to [Rinvoq] alone."
AbbVie's Rinvoq won its original FDA approval in 2019 as a treatment for rheumatoid arthritis. Since then, the company has picked up six additional uses, including its most recent in Crohn's disease.
Rinvoq is a key growth driver for the drugmaker after its Humira tumbled off the patent cliff in January. Last year, the drug pulled down $2.52 billion worldwide, a 53% increase from 2021.