Table 5.
Results from the U-ACHIEVE trial with upadacitinib.
| Placebo [n = 46] | 7.5 mg QD [n = 47] | 15 mg QD [n = 49] | 30 mg QD [n = 52] | 45 mg QD [n = 56] | |
|---|---|---|---|---|---|
| Clinical remission | 0.0% | 8.5% | 14.3%* | 13.5%* | 19.6%** |
| Clinical response | 13.0% | 29.8%* | 44.9%*** | 44.2%*** | 50.0%*** |
| Endoscopic improvement | 2.2% | 14.9%* | 30.6%*** | 26.9%*** | 35.7%*** |
| Endoscopic remission | 0.0% | 6.4% | 4.1% | 9.6%* | 17.9%** |
| Histological improvement | 6.5% | 31.9%** | 51.0%*** | 44.2%*** | 48.2%*** |
| Histological remission | 2.2% | 12.8%* | 22.4%** | 30.8%*** | 41.1%*** |
Clinical remission: clinical remission per adapted Mayo score at Week 8 [stool frequency sub-score ≤1, rectal bleeding sub-score = 0, and endoscopic sub-score ≤1]. Clinical response: clinical response per adapted Mayo score at Week 8 [decrease from baseline in the adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1]. Endoscopic improvement: endoscopic sub-score ≤1. Endoscopic remission: endoscopic sub-score = 0. Histological improvement: any decrease from baseline in the Geboes score. Histological remission: a Geboes score <2.
QD: once daily.
*p <0.05; **p <0.01; ***p <0.001.