Table 1.
Inclusion criteria from SLR to NMA.
| Element | Inclusion |
|---|---|
| Patient population | • Randomized adults (≥16 years) with moderately to severely active UC |
| Interventions | Evaluated the following FDA- and/or EMA-approved biologic or SMD doses: • ADA (subcutaneous [SC] 160 mg at week 0, 80 mg at week 2, and 40 mg at week 4 [ADA160/80] for induction, and SC 40 mg every other week [ADA40Q2W] or every week [ADA40QW] for maintenance) • FIL (oral 100 mg [FIL100] or 200 mg [FIL200] QD for induction and maintenance) • GOL (SC 200 mg at week 0 and 100 mg at week 2 [GOL200/100] for induction, and SC 100 mg [GOL100] or 50 mg [GOL50] every 4 weeks for maintenance) • INF (IV 5 mg/kg [INF5] or 10 mg/kg [INF10a] at weeks 0, 2, and 6 then every 8 weeks for induction and maintenance) • OZA (oral 0.23 mg QD for 4 days, 0.46 mg QD for 3 days, then 0.92 mg QD [OZA0.92] for induction and maintenance) • TOF (oral 10 mg BID [TOF10] for 8 weeks for induction, and oral 5 mg BID [TOF5] or TOF10 for maintenance) • UPA (oral 45 mg QD for 8 weeks [UPA45] for induction, and oral 15 mg [UPA15] or 30 mg [UPA30] QD for maintenance) • UST (IV 6 mg/kg at week 0 [UST6] for induction, and SC 90 mg at week 8 then every 12 weeks [UST90Q12W] or 8 weeks [UST90Q8W] for maintenance) • VED (IV 300 mg at weeks 0, 2, and 6 [VED300] for induction, and IV 300 mg every 8 weeks [VED300Q8W] or every 4 weeks [VED300Q4W] for maintenance) |
| Comparators | • Included an active comparator that enabled network link or PBO |
| Outcomes measures | • Reported an outcome of interest after 6–10 weeks of induction treatment and/or after at least 40 weeks of maintenance treatment |
| Study design | • Double-blinded, phase 3+ RCT |
Abbreviations: ADA, adalimumab; BID, twice daily; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FIL, filgotinib; GOL, golimumab; INF, infliximab; IV, intravenous; NMA, network meta-analysis; OZA, ozanimod; PBO, placebo; QD, once daily; RCT, randomized clinical trial; SC, subcutaneous; SLR, systematic literature review; SMD, small molecule drug; TOF, tofacitinib; UC, ulcerative colitis; UPA, upadacitinib; UST, ustekinumab; VED, vedolizumab.
aDose unapproved but used in clinical practice.