AbbVie’s Upadacitinib Benefits Crohn’s Patients in Phase 2 Trial, Supporting Advance to Phase 3

AbbVie’s Upadacitinib Benefits Crohn’s Patients in Phase 2 Trial, Supporting Advance to Phase 3
A Phase 2 trial (NCT02365649) of AbbVie’s investigational compound upadacitinib (ABT-494) showed the treatment had a positive effect in patients with Crohn’s disease, supporting the drug's advance to Phase 3 trials. Data from the trial, called CELEST, was presented at the Digestive Disease Week 2017 conference May 6-9 in Chicago. The study had particularly focused on patients who had failed previous treatments with immunomodulating drugs or TNF inhibitors, and all patients had moderately to severely active disease. Researchers recruited 220 patients, who were randomized to receive placebo or one of five upadacitinib dose regimens for 16 weeks. The doses investigated were 3, 6, 12, or 24 mg twice daily, or 24 mg once a day. After 16 weeks, an extension phase of 36 weeks followed. Of these, 180 patients completed the study. Endoscopic remission — measured by the Simplified Endoscopic Score for Crohn's Disease scale — was more common in upadacitinib-treated patients. In the 24 mg twice daily treatment group, 22 percent achieved endoscopic remission, compared to none in the placebo group. Endoscopic remission, along with clinical remission, was the trial’s primary outcome measure. Clinical remission was also more common after upadacitinib treatment — with 27 percent in the 6 mg dose group achieving it, compared to 11 percent in the placebo group. "Crohn's disease is a serious, chronic disease with symptoms and complications that can have a major impact on patients' daily lives, and additional treatments are needed to improve the prognosis for many living with the disease," William Sandborn, MD, study investigat
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