Table 3.
Comparative efficacy of pharmacotherapies for induction phase in patients with left sided, extensive colitis and effect modification by disease extend, adjusted for sex, age, disease duration, concomitant corticosteroid use, prior-anti TNF exposure, and treatment arm (pooled analysis).
| Outcomes | Left sided colitis |
Extensive colitis |
Ratio of RRs |
|||
|---|---|---|---|---|---|---|
| Risk ratio | p value for RR = 1 | Risk ratio | p value for RR = 1 | Ratio of risk ratios | p-value for effect modification | |
| Tofacitinib [Week 9] | ||||||
| Clinical responsea (N = 1074) | 1.57 (1.22, 2.02) | <0.001 | 2.34 (1.74, 3.16) | <0.001 | 0.67 (0.45, 0.99) | 0.049 |
| Clinical remissionb (N = 1077) | 2.08 (1.78, 3.67) | <0.001 | 6.43 (2.10, 19.71) | <0.001 | 0.32 (0.09, 1.14) | 0.078 |
| Endoscopic improvementc (N = 1077) | 1.94 (1.29, 2.92) | 0.001 | 2.64 (1.59, 4.40) | <0.001 | 0.73 (0.38, 1.41) | 0.347 |
| Golimumab [week 6] | ||||||
| Clinical responsea (N = 1282) | 1.30 (1.09, 1.56) | 0.004 | 1.65 (1.30, 2.10) | <0.001 | 0.79 (0.58, 1.07) | 0.120 |
| Clinical remissionb (N = 1280) | 2.25 (1.42, 3.56) | <0.001 | 2.06 (1.20, 3.54) | 0.009 | 1.09 (0.54, 2.22) | 0.811 |
| Endoscopic improvementc (N = 1280) | 1.25 (1.02, 1.52) | 0.031 | 1.60 (1.22, 2.10) | 0.001 | 0.78 (0.56, 1.09) | 0.142 |
| Infliximab [week 8] | ||||||
| Clinical responsea (N = 634) | 1.61 (1.26, 2.06) | <0.001 | 1.48 (1.10, 1.99) | 0.010 | 1.09 (0.74, 1.60) | 0.673 |
| Clinical remissionb (N = 633) | 1.74 (1.18, 2.55) | 0.005 | 5.29 (2.22, 12.65) | <0.001 | 0.33 (0.13, 0.85) | 0.021 |
| Endoscopic improvementc (N = 643) | 1.51 (1.22, 1.87) | <0.001 | 1.58 (1.20, 2.10) | 0.001 | 0.95 (0.67, 1.36) | 0.776 |
| Adalimumab [week 8] | ||||||
| Clinical responsea (N = 858) | 1.20 (0.96, 1.50) | 0.109 | 1.28 (1.08, 1.53) | 0.004 | 0.94 (0.71, 1.24) | 0.664 |
| Clinical remissionb (N = 859) | 1.71 (0.92, 3.15) | 0.088 | 1.69 (1.05, 2.71) | 0.031 | 1.01 (0.47, 2.20) | 0.980 |
| Endoscopic improvementc (N = 859) | 1.11 (0.87, 1.41) | 0.397 | 1.23 (1.00, 1.52) | 0.050 | 0.90 (0.65, 1.24) | 0.523 |
| Anti-TNFs combined [Weeks 6–8] | ||||||
| Clinical responsea (N = 2774) | 1.34 (1.19, 1.51) | <0.001 | 1.42 (1.25, 1.61) | <0.001 | 0.94 (0.79, 1.12) | 0.487 |
| Clinical remissionb (N = 2772) | 1.98 (1.51, 2.60) | <0.001 | 2.37 (1.73, 3.27) | <0.001 | 0.84 (0.55, 1.27) | 0.414 |
| Endoscopic improvementc (N = 2782) | 1.28 (1.13, 1.45) | 0.001 | 1.42 (1.24, 1.64) | <0.001 | 0.90 (0.75, 1.08) | 0.257 |
| Vedolizumab [weeks 6] | ||||||
| Clinical responsea (N = 860) | 3.28 (1.24, 8.69) | 0.017 | 3.21 (1.21, 8.50) | 0.019 | 1.02 (0.26, 4.07) | 0.977 |
| Clinical remissionb (N = 860) | 1.44 (0.97, 2.13) | 0.070 | 1.49 (0.97, 2.28) | 0.069 | 0.97 (0.54, 1.73) | 0.918 |
| Endoscopic improvementc (N = 860) | 3.28 (1.24, 8.69) | 0.017 | 3.21 (1.21, 8.50) | 0.019 | 1.02 (0.26, 4.07) | 0.977 |
a
Decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
b
Total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point.
c
Mayo endoscopic sub score of 0 or 1.