AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease.
Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.
Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.
Study participants were poor candidates for conventional or biologic therapy.
The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).
Rinvoq first won FDA approval in 2019 for rheumatoid arthritis. Indications followed for psoriatic arthritis, atopic dermatitis, ulcerative colitis and ankylosing spondylitis.
AbbVie noted that it would include data from the U-ENDURE study as well as the U-EXCEED and U-EXCEL Phase 3 studies in future regulatory submissions.
“We are deeply committed to supporting Crohn’s disease patients who continue to live with challenging symptoms that impact their daily lives,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer at AbbVie, in a statement. “These results represent important progress as we work to bring new treatment options to patients with inflammatory bowel disease.”
The company is studying the use of Rinvoq for several other immune-mediated diseases.
International sales of Rinvoq in 2021 were $1.651 billion.
ABBV shares were mostly flat today, ending up at $151.96.