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. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188

Table 7.

Primary/secondary endpoint of the study – clinical response/remission at t1, stratified according to prior anti-TNF experience. Calculation of the composite primary/secondary endpoint is indicated with the number patients meeting and not meeting the specific requirement (true/false).

Anti-TNF experienced
True/all		 Anti-TNF naïve
True/all
Primary endpoint
 Decrease in partial Mayo score ⩾ 2 (y/ n) 23/43 (53.5%); N = 43 8/9 (88.9%)
 Decrease in partial Mayo score ⩾ 30%  (y/ n) 24/43 (55.8%); N = 43 8/9 (88.9%)
 Decrease in rectal bleeding by 33/43 (76.7%); N = 43 8/9 (88.9%)
  ⩾1 or t1 score ⩽ 1 point (y/ n)
 Marked clinical improvement (y/ n) 22/43 (51.2%); N = 43 8/9 (88.9%)
  Resolution of anemia 0/31 (0%); no anemia at t0 in 22 0/5 (0%); no anemia at t0 in 4
  Improvement of CRP 14/30 (46.7%); normal CRP at t0 in 13 2/5 (40%); normal CRP at t0 in 2
  Improvement of calprotectin 6/15 (40%) 2/2 (100%); normal at t0 in 2
  Improvement of endoscopic findings 1/11 (9.1%); normal at t0 in 1 0/1 (0%); normal at t0 in 1
  Improvement of histology 2/10 (20%); normal at t0 in 1 0/0 (0%)
  Any improvement 17/35 (48.6%) 3/7 (42.9%)
 Primary outcome 12/43 (27.9%) 3/9 (33.3%)
  Outcome tested, persistent  normal + untested 13/43 (30.2%) 7/9 (77.8%)
Secondary endpoint N = 43 N = 9
 t1 normal partial Mayo ⩽ 2 18/43 (41.9%) 6/9 (66.7%)
 t1 no subscore > 1 19/43 (44.2%) 7/9 (77.8%)
 t1 clinical remission 17/43 (39.5%) 6/9 (66.7%)
 No anemia 24/33 (72.7%) 4/5 (80.0%)
 Normal CRP ⩽ 5 21/33 (63.6%) 5/5 (100%)
 Normal calprotectin ⩽ 100 2/15 (13.3%) 1/4 (25%)
 Endoscopy ⩽ 1 1/13 (7.7%) 0/1 (0%)
 Histology ⩽ 1 1/12 (8.3%) 0/0 (0%)
 No evidence residual disease 9/37 (24.3%) 3/7 (42.9%)
 New remission tested 5/38 (11.6%) 3/9 (33.3%)
  New remission tested + not tested 9/34 (20.9%) 4/9 (44.4%)

CRP, C-reactive protein; TNF, tumor necrosis factor.