Table 1:
Differences in prevalence of Mayo endoscopic sub-scores post-induction across patient reported outcome permutations when using local versus central endoscopy scores in tofacitinib trials
| Patient-reported outcome | Endoscopic activity | Local Reads | Central Reads | ||
|---|---|---|---|---|---|
| n/N | Prevalence | n/N | Prevalence | ||
| RBS0 + SFS0/1 | MES 0/1 (p<0.001) | 323/472 | 68.4 (64.1–72.5) | 242/472 | 51.3 (46.8–55.8) |
| MES 0 (p=0.006) | 85/472 | 18.0 (14.8–21.7) | 55/472 | 11.7 (9.1–14.9) | |
| MES 1 (p=0.001) | 238/472 | 50.4 (45.9–54.9) | 187/472 | 39.6 (35.3–44.1) | |
| RBS0 + SFS0 | MES 0/1 (p<0.001) | 150/196 | 76.5 (70.1–81.9) | 112/196 | 57.1 (50.1–63.9) |
| MES 0 (p=0.09) | 43/196 | 21.9 (16.7–28.3) | 30/196 | 15.3 (10.9–21.0) | |
| MES 1 (p=0.01) | 107/196 | 54.6 (47.6–61.4) | 82/196 | 41.8 (35.1–48.9) | |
| RBS0 + SFS2/3 | MES 0/1 (p=0.32) | 35/154 | 22.7 (16.8–30.0) | 28/154 | 18.2 (12.9–25.1) |
| MES 0 (p=0.79) | 7/154 | 4.5 (2.2–9.2) | 8/154 | 5.2 (2.6–10.0) | |
| MES 1 (p=0.21) | 28/154 | 18.2 (12.9–25.1) | 20/154 | 13.0 (8.5–19.3) | |
| RBS 2/3 + SFS2/3 | MES 0/1 (p=0.46) | 10/140 | 7.1 (3.9–12.8) | 7/140 | 5.0 (2.4–10.1) |
| MES 0 (p=1.00) | 0/140 | 0.4 (0.0–5.4) | 0/140 | 0.4 (0.0–5.4) | |
| MES 1 (p=0.46) | 10/140 | 7.1 (3.9–12.8) | 7/140 | 5.0 (2.4–10.1) | |
RBS: rectal bleeding score; SFS: stool frequency score; MES: Mayo endoscopic score