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. 2023 Mar 2;10:1089099. doi: 10.3389/fmed.2023.1089099

TABLE 2.

Major RCTs including JAK inhibitors for UC treatment.

Drug RCT identifier Patient number Treatment phase Duration Dose End point Results
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).