Upadacitinib Meets Primary Endpoint of Clinical Remission in Patients with Ulcerative Colitis


Study’s secondary endpoints were also met, including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement, and corticosteroid-free clinical remission at week 52.

Significantly more patients receiving upadacitinib (Rinvoq, AbbVie) achieved the primary endpoint of clinical remission in a 52-week phase 3 maintenance study, according to a press release.

The phase 3 maintenance study is an ongoing, multicenter, randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of upadacitinib in patients with moderate to severe ulcerative colitis. Results from the 2 induction studies were announced in December 2020 and February 2021.

Upadacitinib is a selective and reversible Janus kinase inhibitor that is being studied in several immune-mediated inflammatory diseases. It received FDA approval in August 2019 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance of methotrexate.

“Ulcerative colitis is a disease with unpredictable symptoms and frequent flares, which can make daily life challenging,” said Michael Severino, MD, vice chairman and president of AbbVie, in the press release. “We are encouraged by these results that demonstrate upadacitinib’s potential as a treatment option for patients with moderate to severe ulcerative colitis.”

In the study, adults with moderate to severe ulcerative colitis who achieved a clinical response following an 8-week period of once-daily upadacitinib (45 mg) induction treatment were re-randomized to receive either 15 mg, 30 mg, or placebo for an additional 52 weeks. Significantly more patients in the upadacitinib-treated arm achieved clinical remission at week 52 compared to placebo, according to the investigators.

Furthermore, all secondary endpoints were met, including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI), and corticosteroid-free clinical remission at week 52. Specifically, 49% of patients treated with upadacitinib 15 mg and 62% of patients treated with 30 mg achieved endoscopic improvement at 52 weeks versus 14% of patients in the placebo group.

Thirty-five percent of patients on upadacitinib 15 mg and 49% of patients on 30 mg achieved HEMI compared to 12% of patients in the placebo group. Among patients who were in remission at the completion of the 8-week induction studies, corticosteroid-free remission was achieved in 57% of patients in the upadacitinib 15 mg group and 68% of patients in the 30 mg group, compared to 22% of patients in the placebo group.

“Ulcerative colitis is a challenging disease to manage, and many patients do not find relief from their most burdensome symptoms,” said Remo Panaccione, MD, a professor of medicine at director of the IBD unit at the University of Calgary, in the press release. “These positive results demonstrate upadacitinib’s potential to achieve improvements in clinical, endoscopic, and histological outcomes at 52 weeks. This is promising news for the IBD community.”

A total of 746 patients who completed the 8-week upadacitinib induction treatment with clinical response and received at least 1 dose of the study drug in the maintenance period were included in the safety analysis. No new safety risks were identified and the most common adverse events observed in the upadacitinib groups were nasopharyngitis, exacerbation of ulcerative colitis, and blood creatine phosphokinase increase.

Reported malignancies (excluding non-melanoma skin cancer) included one event in the upadacitinib 15 mg group, 2 events in the upadacitinib 30 mg group, and 1 event in the placebo group. Adjudicated thrombotic events were reported in the upadacitinib 15 mg group, 30 mg group, and the placebo group, and 1 adjudicated major adverse cardiovascular event was reported in both the upadacitinib 30 mg and 15 mg groups.


Upadacitinib (Rinvoq) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients. News release. AbbVie. June 29, 2021. Accessed July 6, 2021. https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-met-primary-and-all-secondary-endpoints-in-52-week-phase-3-maintenance-study-in-ulcerative-colitis-patients.htm

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