Rinvoq passes PhIII maintenance study for Crohn's disease, potentially setting the stage for label expansion
After AbbVie’s Rinvoq first got approved back in 2019, JAK inhibitors have been clouded by numerous safety issues and events, like with rival Pfizer’s Xeljanz. Now with the newest study out of AbbVie, there might be room to follow the route its sales king Humira did — expanding the drug into other indications and calming concerns about the drug class.
AbbVie announced top-line results earlier this week from a Phase III study for upadacitinib, its JAK inhibitor that had been previously approved for rheumatoid arthritis. The study, called U-ENDURE, was a 52-week maintenance study in adults with moderate to severe Crohn’s disease “who had an inadequate response or were intolerant to a conventional or biologic therapy.” Rinvoq met the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission.
The study enrolled patients from two previous Phase III trials — U-EXCEED and U-EXCEL, which compared patients to placebo at 12 weeks — and gave them a smaller dose for a longer period of time. Both of those studies met the same co-primary endpoints as the ones in U-ENDURE.
According to AbbVie, patients in previous studies were given the JAK inhibitor at a 45mg dose. For this one, patients were randomized to either receive a 30mg dose (168 patients), a 15mg dose (169 patients) or placebo (165 patients).
AbbVie reported its numbers at a p-value of p<0.0001:
- Clinical remission according to the Crohn’s Disease Activity Index: 37% at 15mg, 48% at 30 mg, 15% at placebo.
- Clinical remission as measured by stool frequency and abdominal pain score (SF/AP): 36% at 15mg, 46% at 30 mg, 14% at placebo.
- Endoscopic response: 28% at 15mg, 40% at 30 mg, 7% at placebo.
- Endoscopic remission: 19% at 15mg, 29% at 30 mg, 5% at placebo.
In the case of this study, in particular, no new safety risks were identified.
Rinvoq is AbbVie’s attempt at repeating the vastly expanded franchise of Humira, something that CEO Rick Gonzalez noted on the pharma’s annual earnings call back in February when he said that Rinvoq plus Skyrizi “will be commercialized across all of Humira’s major indications — plus atopic dermatitis.” He further noted at the time that AbbVie expects combined peak sales for both drugs “to exceed the peak revenues achieved by Humira.”
“These results are encouraging and would be particularly important for patients who have not found relief with other conventional or biologic treatment options,” said lead study investigator Julian Panés, who is the head of the IBD Unit at Hospital Clínic de Barcelona.
AbbVie further said that full results from the U-ENDURE study maintenance period will be presented at upcoming medical conferences, and published in a peer-reviewed medical journal — time to be determined. Additionally, data from the study will be used in future regulatory submissions.