Table 2.
GRADE Evidence Profile comparing infliximab, adalimumab, golimumab, vedolizumab and tofacitinib with placebo for induction and maintenance of remission in patients with moderate to severe ulcerative colitis. Note, for tofacitinib, both doses 5mg twice/day and 10mg twice/day were combined for maintenance of remission outcome
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
|---|---|---|---|---|---|---|
| Induction of clinical remission (CRITICAL) | 45/354 (12.7%) | 130/356 (36.5%) | RR 2.85 (2.11 to 3.86) | 185 more per 1,000 (from 111 more to 286 more) | 710 (5 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 48/334 (14.4%) | 108/333 (32.4%) | RR 2.25 (1.67 to 3.05) | 188 more per 1,000 (from 100 more to 307 more) | 667 (4 RCTs) | ⨁⨁⨁◯1 MODERATE |
| ADALIMUMAB COMPARED TO PLACEBO FOR MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 46/472 (9.7%) | 74/468 (15.8%) | RR 1.62 (1.15 to 2.29) | 62 more per 1,000 (from 15 more to 129 more) | 940 (3 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 29/342 (8.5%) | 84/425 (19.8%) | RR 2.28 (1.52 to 3.42) | 192 more per 1,000 (from 78 more to 363 more) | 767 (2 RCTs) | ⨁⨁⨁◯1 MODERATE |
| GOLIMUMAB COMPARED TO PLACEBO FOR MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 23/320 (7.2%) | 58/324 (17.9%) | RR 2.49 (1.58 to 3.93) | 149 more per 1,000 (from 58 more to 239 more) | 644 (2 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 36/185 (19.5%) | 67/183 (36.6%) | RR 1.88 (1.32 to 2.68) | 132 more per 1,000 (from 48 more to 252 more) | 368 (2 RCTs) | ⨁⨁⨁◯1,2 MODERATE |
| VEDOLIZUMAB COMPARED TO PLACEBO FOR MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 18/231 (7.8%) | 68/393 (17.3%) | RR 2.22 (1.36 to 3.64) | 122 more per 1,000 (from 36 more to 264 more) | 624 (2 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 33/168 (19.6%) | 74/163 (45.4%) | RR 2.31 (1.63 to 3.28) | 197 more per 1,000 (from 94 more to 342 more) | 331 (2 RCTs) | ⨁⨁⨁◯1 MODERATE |
| TOFACITINIB COMPARED TO PLACEBO FOR MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 19/282 (6.7%) | 176/938 (18.8%) | RR 3.22 (2.03 to 5.08) | 222 more per 1,000 (from 103 more to 408 more) | 1220 (3 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 22/198 (11.1%) | 149/395 (37.7%) | RR 3.09 (1.99 to 4.79) | 203 more per 1,000 (from 110 more to 308 more) | 593 (1 RCT) | ⨁⨁⨁◯1 MODERATE |
| USTEKINUMAB COMPARED TO PLACEBO FOR MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 17/319 (5.3%) | 50/322 (15.5%) | RR 2.91 (1.72 to 4.94) | 191 more per 1,000 (from 72 more to 394 more) | 641 (1 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 42/175 (24.0%) | 77/176 (43.8%) | RR 1.83 (1.33 to 2.49) | 125 more per 1,000 (from 50 more to 224 more) | 351 (1 RCT) | ⨁⨁⨁◯1 MODERATE |
|
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1
Rated down for imprecision since optimal information size not met (<200 events)
2
Though statistical heterogeneity was noted, with use of fixed effects meta-analysis, estimate was largely driven by larger, high quality trials