Upadacitinib meets primary endpoint for moderate-to-severe UC

Induction of upadacitinib treatment in patients with moderate-to-severe ulcerative colitis (UC) led to higher clinical remission rates than placebo after 8 weeks. Moreover, all ranked secondary endpoints of the phase 3 U-ACCOMPLISH trial were met. The treatment was well tolerated and no new safety issues with upadacitinib were observed.

Upadacitinib is an oral selective and reversible JAK inhibitor. The phase 3 U-ACCOMPLISH trial (NCT03653026) randomised patients with moderate-to-severe active UC to 45 mg once daily upadacitinib (n=344) or placebo (n=177) [1]. The primary endpoint was the proportion of patients in clinical remission at week 8. Clinical remission was defined as Mayo stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1.

Clinical remission was achieved more frequently in the upadacitinib arm (33.4%) than in the placebo arm (4.1%). Ranked secondary endpoints also demonstrated superiority of upadacitinib over placebo: clinical response (74.5% vs 25.4%), endoscopic improvement (44.0% vs 8.3%). Moreover, the fast-acting agent upadacitinib demonstrated significantly higher clinical remission rates than placebo after 2 weeks already.

Adverse events occurred in 52.9% of the upadacitinib subjects and in 39.5% of the placebo subjects. Serious adverse events were limited (upadacitinib 3.2% vs placebo 4.5%). The most common adverse events in the upadacitinib arm were acne, increased blood creatine phosphokinase, and anaemia. These results are consistent with the known safety profile of upadacitinib.

Dr Séverine Vermeire (University hospital Leuven, Belgium)of the study, concluded by arguing that safety and efficacy data of upadacitinib in this study are in line with the U-ACHIEVE study [2]. U-ACHIEVE is a second phase 3 trial presented at ECCO 2021 investigating the safety and efficacy of 45 mg upadacitinib in moderate-to-severe UC patients.

1. Vermeire S, et al. Efficacy and safety of upadacitinib as induction therapy in patients with moderately to severely active Ulcerative Colitis: Results from phase 3 U-ACCOMPLISH study. OP23, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.
2. Danese S, et al. Efficacy and safety of upadacitinib induction therapy in patients with Moderately to Severely Active Ulcerative Colitis: Results from the phase 3 U-ACHIEVE study. OP24, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.

 

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Posted on 2 July 20218 April 2024