Table 1.
Definitions of endpoints in ulcerative colitis clinical trials.
| Trial/Author | Molecule | Clinical Response | Clinical Remission | Endoscopic Response/ Remission |
Time Frame (Weeks) |
|---|---|---|---|---|---|
| UNIFI [2] | USTE | decrease in the total Mayo score ≥30% and ≥3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | total Mayo score ≤ 2 and no subscore > 1) | Mayo endoscopic subscore ≤1 | 8 |
| OCTAVE [3] | TOFA | decrease in the total Mayo score ≥30% and ≥3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | total Mayo score ≤ 2, with no subscore > 1 and a rectal bleeding subscore of 0 | Mayo endoscopic subscore ≤1 | 8 |
| ACT [4] | IFX | decrease in the total Mayo score ≥30% and ≥3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point | Mayo endoscopic subscore ≤1 | 8 |
| ULTRA [5] | ADM | decrease in the total Mayo score ≥ 30% and ≥3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point | Mayo endoscopic subscore ≤1 | 8 |
| PURSUIT-SC [6] | GOL | decrease in the Mayo score ≥ 30% and ≥3 points from baseline, accompanied by either a rectal bleeding subscore of 0 or 1 or a decrease from baseline in the rectal bleeding subscore ≥1 | Mayo endoscopic subscore ≤1 | 6 | |
| UC-SUCCESS [7] | IFX vs. AZA vs. IFX + AZA | decrease in the total Mayo score ≥ 3 points and at least a 30% decrease from baseline | total Mayo score ≤ 2, with no individual subscore exceeding 1 point, without the use of corticosteroids | Mayo endoscopic subscore ≤1 | 16 |
| NCT00385736 [8] | ADM | decrease in Mayo score ≥ 3 points and ≥ 30% from baseline, plus either a decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1 | total Mayo score ≤ 2 and no individual subscore > 1 | Mayo endoscopic subscore ≤1 | 8 |
| SERENE-UC [9] | ADM | decrease in the total Mayo score ≥ 30% and of ≥3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | full Mayo score ≤ 2 with no subscore > 1 | Mayo endoscopic subscore ≤1 | 8 |
| Suzuki Y. et al. [10] | ADM | decrease of ≥3 points and ≥30% from baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1 | full Mayo score ≤2 with no subscore >1 | Mayo endoscopic subscore ≤1 | 8 |
| NCT00787202 [11] | TOFA | decrease in the total Mayo score ≥ 30% and ≥ 3 points from baseline, with an accompanying decrease of ≥1 point on the rectal bleeding component of the Mayo scale or a rectal bleeding subscore of 0 or 1 | total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point | Mayo endoscopic subscore of 0 | |
| NCT02039505 [12] | VEDO | reduction of ≥3 points and ≥30% from baseline in the full Mayo score, and a ≥1 point decrease on the rectal bleeding subscore or an absolute rectal bleeding subscore ≤ 1 | total Mayo score ≤ 2 and no individual subscore > 1 | Mayo endoscopic subscore ≤1 |
AZA = azathioprine, IFX = infliximab; ADM = adalimumab; GOL = golimumab; CTZ = certolizumab; VEDO = vedolizumab; USTE = ustekinumab; TOFA = tofacitinib; NA = not applicable.