Tofacitinib |
NCT01465763, NCT01458951 (14) |
598 + 541 |
Induction |
8 weeks |
10 mg, bid |
Clinical remission at week 8 |
In the OCTAVE Induction 1 trial, remission at 8 weeks occurred in 18.5% of the patients in the tofacitinib group versus 8.2% in the placebo group (P = 0.007); in the OCTAVE Induction 2 trial, remission occurred in 16.6% vs. 3.6 (P < 0.001). |
|
NCT01458574 (14) |
593 |
Maintenance |
52 weeks |
5, 10 mg, bid |
Clinical remission at week 52 |
In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5 mg tofacitinib group and 40.6% in the 10 mg tofacitinib group versus 11.1% in the placebo group (P < 0.001 for both comparisons with placebo). |
|
NCT03281304 (18) |
140 |
Maintenance |
6 months |
5, 10 mg, bid |
Clinical remission at month 6 |
Most patients in stable remission on 10 mg bid maintenance therapy maintained remission following dose de-escalation. For patients who dose de-escalated, those in deep endoscopic remission and those without prior TNFi failure were more likely to maintain remission. |
Upadacitinib |
NCT02819635, NCT03653026 (34) |
474 + 522 |
Induction |
8 weeks |
45 mg, qd |
Clinical remission at week 8 |
More patients achieved clinical remission with upadacitinib 45 mg (26% and 34 in UC1 and UC2, respectively) than in the placebo group (5% and 4 in UC1 and UC2, respectively; p < 0.0001). |
|
NCT02819635, NCT03653026 (34) |
451 |
Maintenance |
52 weeks |
15, 30 mg, qd |
Clinical remission at week 52 |
Clinical remission was achieved by more patients receiving upadacitinib 15 mg (42%) and upadacitinib 30 mg (52%) than those receiving placebo (12%; p < 0.0001). |
Filgotinib |
NCT02914522 (29) |
2040 |
Induction |
10 weeks |
100, 200 mg, qd |
Clinical remission at week 10 |
A greater proportion of patients given filgotinib 200 mg had clinical remission than those given placebo (induction study A 26.1 vs. 15.3%, p = 0.0157; induction study B 11.5% vs. 4.2, p = 0.0103). Clinical remission was not significantly different between filgotinib 100 mg and placebo at week 10. |
|
NCT02914522 (29) |
664 |
Maintenance |
58 weeks |
100, 200 mg, qd |
Clinical remission at week 58 |
37.2% of patients given filgotinib 200 mg had clinical remission versus 11.2% in the placebo group (p < 0.0001). Clinical remission was significantly different between filgotinib 100 mg and placebo by week 58 (23.8% vs. 13.5, p = 0.0420). |