Table 4.
Induction efficacy outcomes at Week 6 | Week 6 SGC [µg/ml] | p-Value | |
---|---|---|---|
Achieved | Not Achieved | ||
Clinical responsea | 2.96 [n = 373] |
1.55 [n = 320] |
< 0.001 |
Mucosal healingb | 3.14 [n = 315] |
1.70 [n = 378] |
< 0.001 |
Clinical remissionc | 3.14 [n = 134] |
2.13 [n = 559] |
< 0.001 |
Maintenance efficacy outcomes | Week 44 SGC [µg/ml] | p-Value | |
Achieved | Not achieved | ||
Clinical responsea through Week 54 | 1.17 [n = 142] |
0.83 [n = 57] |
0.003 |
Mucosal healingb at Week 30 and Week 54 | 1.22 [n = 124] |
0.83 [n = 75] |
0.005 |
Clinical remissionc at Week 30 and Week 54 | 1.50 [n = 74] |
0.87 [n = 125] |
< 0.001 |
aClinical response was defined as a decrease from baseline in the Mayo score ≥ 30% and ≥ 3 points, accompanied by either a rectal bleeding subscore of 0 or 1 or a decrease from baseline in the rectal bleeding subscore ≥ 1.
bMucosal healing was defined as a Mayo endoscopy subscore of 0 or 1.
cClinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
PURSUIT, Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment; SGC, serum golimumab concentration.