TABLE 2.
Clinical Outcomes: Tofacitinib vs Ustekinumab
| Outcomes | Tofacitinib | Ustekinumab | P * |
|---|---|---|---|
| Steroid-free clinical remission 12-16 wks, fraction (%) | 18/41 (43.9) | 14/35 (40.0) | 0.82 |
| Steroid-free clinical response 12-16 wks, fraction (%) | 19/41 (46.3) | 17/35 (48.6) | 1.00 |
| Colectomy-free drug survival, fraction (%)† | 22/45 (48.9) | 23/36 (63.9) | 0.75 |
| Adverse drug reaction or infection, fraction (%)† | 5/45 (11.1) | 2/36 (5.6) | 0.57 |
| Steroid-free clinical remission 52 wks, fraction (%) | 15/25 (60.0) | 6/11 (54.6) | — |
| Endoscopic remission, fraction (%)† | 7/25 (28.0) | 3/18 (16.7) | — |
| Dose de-escalation, fraction (%)‡ | 17/45 (37.8) | — | — |
| Dose escalation, fraction (%)‡ | — | 12/36 (33.3) | — |
*Calculated using Fisher exact test or log-rank test. The last 4 outcomes are intended to be descriptive, so P values are not calculated.
† These outcomes are assessed over all available follow-up of 675 days (IQR, 537-1106 days) for tofacitinib and 407 days (IQR, 207-1191 days) for ustekinumab.
‡These outcomes were assessed at any point over all available follow-up. In the tofacitinib group, 17 patients underwent dose de-escalation to a total daily dose of 10 mg (n = 15) or 15 mg (n = 2). In the ustekinumab group, 12 patients underwent dose escalation to every 4 weeks (n = 6) or every 6 weeks (n = 6).
IQR indicates interquartile range.