A phase 3 induction study evaluating upadacitinib for the treatment of adults with moderate to severe ulcerative colitis met its primary and all ranked secondary end points.
The multicenter, randomized, double-blind, placebo controlled U-ACCOMPLISH study (ClinicalTrials.gov: NCT03653026) evaluated the efficacy and safety of upadacitinib in 515 adults with moderate to severe ulcerative colitis. Patients were randomly assigned 2:1 to receive upadacitinib 45mg orally once daily or placebo for 8 weeks. The primary end point was the proportion of patients who achieved clinical remission per Adapted Mayo Score.
Findings from the study showed that 33% of patients treated with upadacitinib achieved clinical remission at week 8 compared with 4% of patients treated with placebo (P <.001). Moreover, the study met all ranked secondary end points with a greater proportion of patients treated with upadacitinib achieving the following results compared with placebo, respectively:
- Percent of patients experiencing clinical response per Adapted Mayo Score at week 8: 74% vs 25% (P <.001); and at week 2: 63% vs 26% (P <.001);
- Percent of patients achieving endoscopic improvement at week 8: 44% vs 8% (P <.001);
- Percent of patients achieving histologic-endoscopic mucosal improvement at week 8: 37% vs 6% (P <.001).
The safety profile of upadacitinib was consistent with that seen in previous studies across indications, including a previously reported phase 3 induction study in ulcerative colitis. The most common adverse events reported in upadacitinib-treated patients were acne, increased blood creatine phosphokinase and anemia. Serious adverse events occurred in 3.2% of the upadacitinib group and 4.5% of the placebo group.
According to the Company, full study results will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
Upadacitinib, a selective and reversible Janus kinase (JAK) inhibitor, is marketed under the trade name Rinvoq and is currently approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
Second phase 3 induction study confirms upadacitinib (Rinvoq™) improved clinical, endoscopic and histologic outcomes in ulcerative colitis patients. [press release]. North Chicago, IL: AbbVie; February 22, 2021.