Definitions of end points used in clinical trials in patients with active ulcerative colitis.
| Trial . | Drug . | End Point(s) . | Definition . |
|---|---|---|---|
| ASCEND II9 | Delayed-release mesalamine | Complete remission | Normal stool frequency, no rectal bleeding, patient’s functional assessment, normal endoscopy findings and physician global assessment score of 0. |
| Clinical response | Improvement in the baseline physician global assessment score and improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient’s functional assessment, and endoscopy findings) and no worsening in any other clinical assessment. | ||
| MEZAVANT10 | Mesalamine MMX | Clinical remission | Normal stool frequency, no rectal bleeding and combined physician global assessment score and sigmoidoscopy score <1 (no friability) (Modified UCDAI) |
| PINCE11 | Combined oral and rectal mesalamine | Clinical remission | Total UCDAI score ≤1 (calculated as sum of stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) |
| SALOFALK12 | Mesalamine granules | Clinical Remission | Clinical activity index ≤4 (calculated as sum of the scores of number of weekly stools, bloody stools, abdominal pain, general well-being, body temperature, extra-intestinal manifestations, erythrocyte sedimentation rate/haemoglobin) |
| CORE I/II13,14 | Budesonide MMX | Clinical remission | Total UCDAI score ≤1 (including rectal bleeding score of 0, stool frequency score of 0, mucosal appearance score of 0 (no sign of mucosal friability on full colonoscopy) |
| Endoscopic Remission | A ≥1-point reduction in baseline endoscopic index score (scored for granulation scattering reflected light, vascular pattern, vulnerability of the mucosa, and mucosal damage)23 | ||
| Symptom resolution | Rectal bleeding and stool frequency UCDAI subscores of 0 | ||
| Endoscopic improvement | ≥1-point reduction in the endoscopy subscore of the UCDAI from baseline | ||
| Histological healing | Defined as a total score of ≤1 in Saverymuttu criteria24 | ||
| ACT I/II15 | Infliximab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| GEMINI I16 | Vedolizumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| ULTRA I/II17,18 | Adalimumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Partial Mayo score clinical remissiona | Partial Mayo score ≤2 points, with no individual sub score exceeding 1 point. | ||
| Mild diseaseb | Mayo subscores of rectal bleeding subscore ≤1, physician’s global assessment subscore ≤1, or stool frequency subscore ≤1). | ||
| OCTAVE19 | Tofacitinib | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Endoscopic remission | Mayo endoscopic sub score of 0 | ||
| Symptomatic remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point, and both rectal bleeding and stool frequency sub score of 0 | ||
| Deep remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point and both endoscopic and rectal bleeding sub score of 0 | ||
| UNIFI20 | Ustekinumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Endoscopic improvement | Mayo endoscopy subscore of 0 or 1 | ||
| Histological improvement | Neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue | ||
| Histo-endoscopic mucosal healing | Both histologic and endoscopic improvement | ||
| TOUCHSTONE21 | Ozanimod | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Histological Remission | Geboe’s score <2 | ||
| U-ACHIEVE22 | Upadacitinib | Clinical remission | Stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore of ≤1 (Adapted Mayo Score) |
| Clinical response | According to Partial Mayo score Decrease from baseline in the partial Mayo score of ≤2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 According to Adapted Mayo Score Decrease from baseline in the adapted Mayo score of ≥2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 | ||
| Endoscopic response | Mayo endoscopy subscore of ≤1 | ||
| Endoscopic remission | Mayo endoscopy subscore of 0 | ||
| Histological Remission | Geboe’s score <2 | ||
| Histological response | Any decrease from baseline in Geboe’s score |
| Trial . | Drug . | End Point(s) . | Definition . |
|---|---|---|---|
| ASCEND II9 | Delayed-release mesalamine | Complete remission | Normal stool frequency, no rectal bleeding, patient’s functional assessment, normal endoscopy findings and physician global assessment score of 0. |
| Clinical response | Improvement in the baseline physician global assessment score and improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient’s functional assessment, and endoscopy findings) and no worsening in any other clinical assessment. | ||
| MEZAVANT10 | Mesalamine MMX | Clinical remission | Normal stool frequency, no rectal bleeding and combined physician global assessment score and sigmoidoscopy score <1 (no friability) (Modified UCDAI) |
| PINCE11 | Combined oral and rectal mesalamine | Clinical remission | Total UCDAI score ≤1 (calculated as sum of stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) |
| SALOFALK12 | Mesalamine granules | Clinical Remission | Clinical activity index ≤4 (calculated as sum of the scores of number of weekly stools, bloody stools, abdominal pain, general well-being, body temperature, extra-intestinal manifestations, erythrocyte sedimentation rate/haemoglobin) |
| CORE I/II13,14 | Budesonide MMX | Clinical remission | Total UCDAI score ≤1 (including rectal bleeding score of 0, stool frequency score of 0, mucosal appearance score of 0 (no sign of mucosal friability on full colonoscopy) |
| Endoscopic Remission | A ≥1-point reduction in baseline endoscopic index score (scored for granulation scattering reflected light, vascular pattern, vulnerability of the mucosa, and mucosal damage)23 | ||
| Symptom resolution | Rectal bleeding and stool frequency UCDAI subscores of 0 | ||
| Endoscopic improvement | ≥1-point reduction in the endoscopy subscore of the UCDAI from baseline | ||
| Histological healing | Defined as a total score of ≤1 in Saverymuttu criteria24 | ||
| ACT I/II15 | Infliximab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| GEMINI I16 | Vedolizumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| ULTRA I/II17,18 | Adalimumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Partial Mayo score clinical remissiona | Partial Mayo score ≤2 points, with no individual sub score exceeding 1 point. | ||
| Mild diseaseb | Mayo subscores of rectal bleeding subscore ≤1, physician’s global assessment subscore ≤1, or stool frequency subscore ≤1). | ||
| OCTAVE19 | Tofacitinib | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Endoscopic remission | Mayo endoscopic sub score of 0 | ||
| Symptomatic remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point, and both rectal bleeding and stool frequency sub score of 0 | ||
| Deep remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point and both endoscopic and rectal bleeding sub score of 0 | ||
| UNIFI20 | Ustekinumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Endoscopic improvement | Mayo endoscopy subscore of 0 or 1 | ||
| Histological improvement | Neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue | ||
| Histo-endoscopic mucosal healing | Both histologic and endoscopic improvement | ||
| TOUCHSTONE21 | Ozanimod | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Histological Remission | Geboe’s score <2 | ||
| U-ACHIEVE22 | Upadacitinib | Clinical remission | Stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore of ≤1 (Adapted Mayo Score) |
| Clinical response | According to Partial Mayo score Decrease from baseline in the partial Mayo score of ≤2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 According to Adapted Mayo Score Decrease from baseline in the adapted Mayo score of ≥2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 | ||
| Endoscopic response | Mayo endoscopy subscore of ≤1 | ||
| Endoscopic remission | Mayo endoscopy subscore of 0 | ||
| Histological Remission | Geboe’s score <2 | ||
| Histological response | Any decrease from baseline in Geboe’s score |
Abbreviations: UCDAI, ulcerative colitis disease activity index; MMX, Multi Matrix technology formulation
aonly defined in ULTRA-II trial;
bonly defined in ULTRA I trial
Definitions of end points used in clinical trials in patients with active ulcerative colitis.
| Trial . | Drug . | End Point(s) . | Definition . |
|---|---|---|---|
| ASCEND II9 | Delayed-release mesalamine | Complete remission | Normal stool frequency, no rectal bleeding, patient’s functional assessment, normal endoscopy findings and physician global assessment score of 0. |
| Clinical response | Improvement in the baseline physician global assessment score and improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient’s functional assessment, and endoscopy findings) and no worsening in any other clinical assessment. | ||
| MEZAVANT10 | Mesalamine MMX | Clinical remission | Normal stool frequency, no rectal bleeding and combined physician global assessment score and sigmoidoscopy score <1 (no friability) (Modified UCDAI) |
| PINCE11 | Combined oral and rectal mesalamine | Clinical remission | Total UCDAI score ≤1 (calculated as sum of stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) |
| SALOFALK12 | Mesalamine granules | Clinical Remission | Clinical activity index ≤4 (calculated as sum of the scores of number of weekly stools, bloody stools, abdominal pain, general well-being, body temperature, extra-intestinal manifestations, erythrocyte sedimentation rate/haemoglobin) |
| CORE I/II13,14 | Budesonide MMX | Clinical remission | Total UCDAI score ≤1 (including rectal bleeding score of 0, stool frequency score of 0, mucosal appearance score of 0 (no sign of mucosal friability on full colonoscopy) |
| Endoscopic Remission | A ≥1-point reduction in baseline endoscopic index score (scored for granulation scattering reflected light, vascular pattern, vulnerability of the mucosa, and mucosal damage)23 | ||
| Symptom resolution | Rectal bleeding and stool frequency UCDAI subscores of 0 | ||
| Endoscopic improvement | ≥1-point reduction in the endoscopy subscore of the UCDAI from baseline | ||
| Histological healing | Defined as a total score of ≤1 in Saverymuttu criteria24 | ||
| ACT I/II15 | Infliximab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| GEMINI I16 | Vedolizumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| ULTRA I/II17,18 | Adalimumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Partial Mayo score clinical remissiona | Partial Mayo score ≤2 points, with no individual sub score exceeding 1 point. | ||
| Mild diseaseb | Mayo subscores of rectal bleeding subscore ≤1, physician’s global assessment subscore ≤1, or stool frequency subscore ≤1). | ||
| OCTAVE19 | Tofacitinib | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Endoscopic remission | Mayo endoscopic sub score of 0 | ||
| Symptomatic remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point, and both rectal bleeding and stool frequency sub score of 0 | ||
| Deep remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point and both endoscopic and rectal bleeding sub score of 0 | ||
| UNIFI20 | Ustekinumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Endoscopic improvement | Mayo endoscopy subscore of 0 or 1 | ||
| Histological improvement | Neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue | ||
| Histo-endoscopic mucosal healing | Both histologic and endoscopic improvement | ||
| TOUCHSTONE21 | Ozanimod | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Histological Remission | Geboe’s score <2 | ||
| U-ACHIEVE22 | Upadacitinib | Clinical remission | Stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore of ≤1 (Adapted Mayo Score) |
| Clinical response | According to Partial Mayo score Decrease from baseline in the partial Mayo score of ≤2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 According to Adapted Mayo Score Decrease from baseline in the adapted Mayo score of ≥2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 | ||
| Endoscopic response | Mayo endoscopy subscore of ≤1 | ||
| Endoscopic remission | Mayo endoscopy subscore of 0 | ||
| Histological Remission | Geboe’s score <2 | ||
| Histological response | Any decrease from baseline in Geboe’s score |
| Trial . | Drug . | End Point(s) . | Definition . |
|---|---|---|---|
| ASCEND II9 | Delayed-release mesalamine | Complete remission | Normal stool frequency, no rectal bleeding, patient’s functional assessment, normal endoscopy findings and physician global assessment score of 0. |
| Clinical response | Improvement in the baseline physician global assessment score and improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient’s functional assessment, and endoscopy findings) and no worsening in any other clinical assessment. | ||
| MEZAVANT10 | Mesalamine MMX | Clinical remission | Normal stool frequency, no rectal bleeding and combined physician global assessment score and sigmoidoscopy score <1 (no friability) (Modified UCDAI) |
| PINCE11 | Combined oral and rectal mesalamine | Clinical remission | Total UCDAI score ≤1 (calculated as sum of stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) |
| SALOFALK12 | Mesalamine granules | Clinical Remission | Clinical activity index ≤4 (calculated as sum of the scores of number of weekly stools, bloody stools, abdominal pain, general well-being, body temperature, extra-intestinal manifestations, erythrocyte sedimentation rate/haemoglobin) |
| CORE I/II13,14 | Budesonide MMX | Clinical remission | Total UCDAI score ≤1 (including rectal bleeding score of 0, stool frequency score of 0, mucosal appearance score of 0 (no sign of mucosal friability on full colonoscopy) |
| Endoscopic Remission | A ≥1-point reduction in baseline endoscopic index score (scored for granulation scattering reflected light, vascular pattern, vulnerability of the mucosa, and mucosal damage)23 | ||
| Symptom resolution | Rectal bleeding and stool frequency UCDAI subscores of 0 | ||
| Endoscopic improvement | ≥1-point reduction in the endoscopy subscore of the UCDAI from baseline | ||
| Histological healing | Defined as a total score of ≤1 in Saverymuttu criteria24 | ||
| ACT I/II15 | Infliximab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| GEMINI I16 | Vedolizumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| ULTRA I/II17,18 | Adalimumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Partial Mayo score clinical remissiona | Partial Mayo score ≤2 points, with no individual sub score exceeding 1 point. | ||
| Mild diseaseb | Mayo subscores of rectal bleeding subscore ≤1, physician’s global assessment subscore ≤1, or stool frequency subscore ≤1). | ||
| OCTAVE19 | Tofacitinib | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Endoscopic remission | Mayo endoscopic sub score of 0 | ||
| Symptomatic remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point, and both rectal bleeding and stool frequency sub score of 0 | ||
| Deep remission | Total Mayo score of ≤2 points, with no individual sub score exceeding 1 point and both endoscopic and rectal bleeding sub score of 0 | ||
| UNIFI20 | Ustekinumab | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Endoscopic improvement | Mayo endoscopy subscore of 0 or 1 | ||
| Histological improvement | Neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue | ||
| Histo-endoscopic mucosal healing | Both histologic and endoscopic improvement | ||
| TOUCHSTONE21 | Ozanimod | Clinical Remission | Total Mayo score ≤2 points with no individual sub score (stool frequency, rectal bleeding, endoscopic appearance and physician global assessment) exceeding 1 point |
| Clinical Response | Decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 | ||
| Mucosal Healing | Mayo endoscopy subscore of 0 or 1 | ||
| Histological Remission | Geboe’s score <2 | ||
| U-ACHIEVE22 | Upadacitinib | Clinical remission | Stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore of ≤1 (Adapted Mayo Score) |
| Clinical response | According to Partial Mayo score Decrease from baseline in the partial Mayo score of ≤2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 According to Adapted Mayo Score Decrease from baseline in the adapted Mayo score of ≥2 points and ≥30% from baseline, plus a decrease in rectal bleeding score by ≥1 or an absolute rectal bleeding score of ≤1 | ||
| Endoscopic response | Mayo endoscopy subscore of ≤1 | ||
| Endoscopic remission | Mayo endoscopy subscore of 0 | ||
| Histological Remission | Geboe’s score <2 | ||
| Histological response | Any decrease from baseline in Geboe’s score |
Abbreviations: UCDAI, ulcerative colitis disease activity index; MMX, Multi Matrix technology formulation
aonly defined in ULTRA-II trial;
bonly defined in ULTRA I trial
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