Table 2.
Corticosteroid use at wk 8 n = 85a |
Response at wk 12 (SCCAI <5) n = 73b |
Remission at wk 12 (SCCAI ≤2) N = 73b |
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Yes n = 25 |
No n = 57 |
P value | Yes n = 57 |
No n = 14 |
P value | Yes n = 38 |
No n = 33 |
P value | |
Response at wk 52 (SCCAI < 5) n = 44 | 36% | 60% | 0.05 | 70% | 29% | 0.004 | 71% | 50% | 0.01 |
Remission at wk 52 (SCCAI ≤2) n = 32 | 24% | 46% | 0.07 | 51% | 21% | 0.05 | 53% | 35% | 0.03 |
Response was defined as mild or no clinical disease activity at the time point of evaluation and remission as no disease activity at the time point of evaluation.
Other factors not associated with mild disease activity or remission at week 52 included the following: Mayo endoscopic score 3 vs ≥3 at baseline, <2 vs ≥2 previous biologic failures before initiation of tofacitinib, mild disease activity (SCCAI <5) or remission status (SCCAI ≤2) at week 8 or corticosteroid use at week 12.
SCCAI, simple clinical colitis activity index.
85 patients in the study, but for 3 patients, steroid use was not known at week 8.
73 patients in the study, but for 2 patients, SCCAI values were not known in the predefined time frame week 12.