Demographics and disease characteristics at True North baseline of patients who entered the OLE in clinical response.
Characteristic . | Week 52 clinical respondersa [n = 131] . |
---|---|
Age, y, mean [SD] | 44.3 [13.6] |
Female, n [%] | 68 [51.9] |
Body mass index, kg/m2, mean [SD] | 25.9 [5.8] |
Age at UC diagnosis, y, mean [SD] | 36.1 [13.4] |
Years since UC diagnosis, mean [SD] | 8.5 [7.3] |
Extent of UC disease, n [%] | |
Left-sided | 89 [67.9] |
Extensive | 42 [32.1] |
Corticosteroid use at screening, n [%] | 31 [23.7] |
Prior therapies, n [%] | |
5-ASA | 129 [98.5] |
Corticosteroid | 90 [68.7] |
Immunomodulator | 46 [35.1] |
Any biologicb | 46 [35.1] |
TNF inhibitor | 42 [32.1] |
Non-TNF inhibitor biologic | 26 [19.8] |
Characteristic . | Week 52 clinical respondersa [n = 131] . |
---|---|
Age, y, mean [SD] | 44.3 [13.6] |
Female, n [%] | 68 [51.9] |
Body mass index, kg/m2, mean [SD] | 25.9 [5.8] |
Age at UC diagnosis, y, mean [SD] | 36.1 [13.4] |
Years since UC diagnosis, mean [SD] | 8.5 [7.3] |
Extent of UC disease, n [%] | |
Left-sided | 89 [67.9] |
Extensive | 42 [32.1] |
Corticosteroid use at screening, n [%] | 31 [23.7] |
Prior therapies, n [%] | |
5-ASA | 129 [98.5] |
Corticosteroid | 90 [68.7] |
Immunomodulator | 46 [35.1] |
Any biologicb | 46 [35.1] |
TNF inhibitor | 42 [32.1] |
Non-TNF inhibitor biologic | 26 [19.8] |
5-ASA, 5-aminosalicylate; OLE, open-label extension; RBS, rectal bleeding subscore; SFS, stool frequency subscore; TNF, tumour necrosis factor; UC, ulcerative colitis.
aClinical response is defined as a reduction from baseline in the 3-component Mayo score [sum of RBS, SFS, and endoscopy subscore] of ≥2 points and ≥35% and reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.
bExcluding three patients exposed to only Janus kinase inhibitors.
Demographics and disease characteristics at True North baseline of patients who entered the OLE in clinical response.
Characteristic . | Week 52 clinical respondersa [n = 131] . |
---|---|
Age, y, mean [SD] | 44.3 [13.6] |
Female, n [%] | 68 [51.9] |
Body mass index, kg/m2, mean [SD] | 25.9 [5.8] |
Age at UC diagnosis, y, mean [SD] | 36.1 [13.4] |
Years since UC diagnosis, mean [SD] | 8.5 [7.3] |
Extent of UC disease, n [%] | |
Left-sided | 89 [67.9] |
Extensive | 42 [32.1] |
Corticosteroid use at screening, n [%] | 31 [23.7] |
Prior therapies, n [%] | |
5-ASA | 129 [98.5] |
Corticosteroid | 90 [68.7] |
Immunomodulator | 46 [35.1] |
Any biologicb | 46 [35.1] |
TNF inhibitor | 42 [32.1] |
Non-TNF inhibitor biologic | 26 [19.8] |
Characteristic . | Week 52 clinical respondersa [n = 131] . |
---|---|
Age, y, mean [SD] | 44.3 [13.6] |
Female, n [%] | 68 [51.9] |
Body mass index, kg/m2, mean [SD] | 25.9 [5.8] |
Age at UC diagnosis, y, mean [SD] | 36.1 [13.4] |
Years since UC diagnosis, mean [SD] | 8.5 [7.3] |
Extent of UC disease, n [%] | |
Left-sided | 89 [67.9] |
Extensive | 42 [32.1] |
Corticosteroid use at screening, n [%] | 31 [23.7] |
Prior therapies, n [%] | |
5-ASA | 129 [98.5] |
Corticosteroid | 90 [68.7] |
Immunomodulator | 46 [35.1] |
Any biologicb | 46 [35.1] |
TNF inhibitor | 42 [32.1] |
Non-TNF inhibitor biologic | 26 [19.8] |
5-ASA, 5-aminosalicylate; OLE, open-label extension; RBS, rectal bleeding subscore; SFS, stool frequency subscore; TNF, tumour necrosis factor; UC, ulcerative colitis.
aClinical response is defined as a reduction from baseline in the 3-component Mayo score [sum of RBS, SFS, and endoscopy subscore] of ≥2 points and ≥35% and reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.
bExcluding three patients exposed to only Janus kinase inhibitors.
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