TABLE 1.
Demographics and Baseline Disease Characteristics for Patients in the Pooled OCTAVE Induction 1 and 2 Studies (FAS)
| All Patients | TNFi-naïve Patients | TNFi-experienced Patients | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (N = 234) | Tofacitinib 10 mg BID (N = 905) | Overall (N = 1139) | Placebo (N = 104) | Tofacitinib 10 mg BID (N = 417) | Overall (N = 521) | Placebo (N = 130) | Tofacitinib 10 mg BID (N = 488) | Overall (N = 618) | |
| Age (years), mean (SD) | 41.1 (14.4) | 41.2 (13.8) | 41.2 (13.9) | 43.2 (13.9) | 41.1 (13.5) | 41.5 (13.6) | 39.4 (14.5) | 41.3 (14.1) | 40.9 (14.2) |
| Male, n (%) | 132 (56.4) | 536 (59.2) | 668 (58.6) | 64 (61.5) | 249 (59.7) | 313 (60.1) | 68 (52.3) | 287 (58.8) | 355 (57.4) |
| White, n (%) | 186 (79.5) | 726 (80.2) | 912 (80.1) | 83 (79.8) | 335 (80.3) | 418 (80.2) | 103 (79.2) | 391 (80.1) | 494 (79.9) |
| Never smoked, n (%) | 161 (68.8) | 569 (62.9) | 730 (64.1) | 75 (72.1) | 282 (67.6) | 357 (68.5) | 86 (66.2) | 287 (58.8) | 373 (60.4) |
| Body mass index (kg/ m2),a mean (SD) | 24.6 (4.7) | 24.9 (5.0) | 24.8 (4.9) | 24.9 (4.3) | 25.2 (5.2) | 25.2 (5.0) | 24.4 (5.0) | 24.6 (4.8) | 24.6 (4.9) |
| Disease extent,b n (%) | |||||||||
| Proctosigmoiditis | 35 (15.0) | 132 (14.6) | 167 (14.7) | 23 (22.3) | 69 (16.6) | 92 (17.7) | 12 (9.2) | 63 (12.9) | 75 (12.2) |
| Left-sided colitis | 76 (32.6) | 307 (34.0) | 383 (33.7) | 35 (34.0) | 160 (38.5) | 195 (37.6) | 41 (31.5) | 147 (30.2) | 188 (30.5) |
| Extensive/ pancolitis | 122 (52.4) | 463 (51.3) | 585 (51.5) | 45 (43.7) | 186 (44.7) | 231 (44.5) | 77 (59.2) | 277 (56.9) | 354 (57.4) |
| Proctitis | 0 (0.0) | 1 (0.1)c | 1 (0.1) | 0 (0.0) | 1 (0.2)c | 1 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Extraintestinal manifestations present,d n (%) | 58 (24.9) | 249 (27.6) | 307 (27.0) | 15 (14.6) | 101 (24.3) | 116 (22.4) | 43 (33.1) | 148 (30.4) | 191 (31.0) |
| Mayo score,e mean (SD) | 9.0 (1.5) | 9.0 (1.4) | 9.0 (1.4) | 8.8 (1.4) | 8.8 (1.4) | 8.8 (1.4) | 9.1 (1.5) | 9.1 (1.4) | 9.1 (1.4) |
| Prior TNFi treatment, n (%) | 130 (55.6) | 488 (53.9) | 618 (54.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 130 (100.0) | 488 (100.0) | 618 (100.0) |
| Prior corticosteroid treatment, n (%) | 217 (92.7) | 812 (89.7) | 1029 (90.3) | 101 (97.1) | 375 (89.9) | 476 (91.4) | 116 (89.2) | 437 (89.5) | 553 (89.5) |
| Oral corticosteroid use at baseline, n (%) | 113 (48.3) | 412 (45.5) | 525 (46.1) | 44 (42.3) | 173 (41.5) | 217 (41.7) | 69 (53.1) | 239 (49.0) | 308 (49.8) |
| <15 mg/dayf | 35 (34.3) | 122 (32.4) | 157 (32.8) | 14 (33.3) | 49 (29.3) | 63 (30.1) | 21 (35.0) | 73 (34.9) | 94 (34.9) |
| ≥15 mg/dayf | 67 (65.7) | 254 (67.6) | 321 (67.2) | 28 (66.7) | 118 (70.7) | 146 (69.9) | 39 (65.0) | 136 (65.1) | 175 (65.1) |
| Prior immunosuppressant treatment, n (%) | 160 (68.4) | 683 (75.5) | 843 (74.0) | 57 (54.8) | 266 (63.8) | 323 (62.0) | 103 (79.2) | 417 (85.5) | 520 (84.1) |
| Prior immunosuppressant failure, n (%) | 158 (67.5) | 661 (73.0) | 819 (71.9) | 57 (54.8) | 263 (63.1) | 320 (61.4) | 101 (77.7) | 398 (81.6) | 499 (80.7) |
aAll patients: placebo, N = 233; 10 mg of tofacitinib BID, N = 905; TNFi-naïve patients: placebo, N = 104; 10 mg of tofacitinib BID, N = 417; TNFi-experienced patients: placebo, N = 129; 10 mg of tofacitinib BID, N = 488; bAll patients: placebo, N = 233; 10 mg of tofacitinib BID, N = 903; TNFi-naïve patients: placebo, N = 103; 10 mg of tofacitinib BID, N = 416; TNFi-experienced patients: placebo, N = 130; 10 mg of tofacitinib BID, N = 487; cOne patient with proctitis was enrolled as a protocol deviation; dAll patients: placebo, N = 233; 10 mg of tofacitinib BID, N = 902; TNFi-naïve patients: placebo, N = 103; 10 mg of tofacitinib BID, N = 415; TNFi-experienced patients: placebo, N = 130; 10 mg of tofacitinib BID, N = 487; eAll patients: placebo, N = 233; 10 mg of tofacitinib BID, N = 903; TNFi-naïve patients: placebo, N = 104; 10 mg of tofacitinib BID, N = 417; TNFi-experienced patients: placebo, N = 129; 10 mg of tofacitinib BID, N = 486; fAll patients: placebo, N = 102; 10 mg of tofacitinib BID, N = 376; TNFi-naïve patients: placebo, N = 42; 10 mg of tofacitinib BID, N = 167; TNFi experienced patients: placebo, N = 60; 10 mg of tofacitinib BID, N = 209; excludes patients who took budesonide or beclometasone.
Abbreviation: FAS, full analysis set.