Table 2.
CT-P13 compared to infliximab originator for active Crohn’s disease naive to anti-TNF therapy: summary of findings table
| Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | CT-P13 | infliximab originator | Relative (95% CI) | Absolute (95% CI) | ||
| Crohn’s disease remission (follow up: mean 6 weeks; assessed with: A reduction of CDAI > 70 points) | ||||||||||||
| 1 | Randomised trials | Not serious | Not serious | Not serious | Very serious a | None | 77/111 (69.4%) | 81/109 (74.3%) | RR 0.96 (0.76–1.22) | 30 fewer per 1,000 (from 178 fewer to 163 more) | ⨁⨁◯◯ LOW | CRITICAL |
| Switch to another biologic (follow up: mean 12 months; assessed with: Switch of drug in administrative database) | ||||||||||||
| 1 | Observational studies | Very serious b | Not serious | Not serious | Not serious | None | 312/2499 (12.5%) | 406/2551 (15.9%) | HR 0.93 (0.79–1.08) | 10 fewer per 1,000 (from 31 fewer to 12 more) | ⨁⨁◯◯ LOW | CRITICAL |
| Serious infections (follow up: mean 12 months; assessed with: Administrative database) | ||||||||||||
| 1 | Observational studies | Serious b | Not serious | Not serious | Serious c | None | 83/2499 (3.3%) | 115/2551 (4.5%) | HR 0.82 (0.61–1.11) | 8 fewer per 1,000 (from 17 fewer to 5 more) | ⨁⨁◯◯ LOW | CRITICAL |
CI, confidence interval; HR, hazard ratio explanations; RR, risk ratio.
aPossibility that CT-P13 is up to 15% less effective than infliximab originator. This was felt to be an important difference when substituting one drug for a similar drug.
bDecision to use CT-P13 was up to patient and clinician.
c95% CI include important differences in safety.