Table 4.
GRADE Evidence Profile comparing natalizumab with placebo for induction and maintenance of remission, and risk of progressive multifocal leukoencephalopathy in patients with moderate to severe luminal Crohn’s disease.
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
|---|---|---|---|---|---|---|
| Risk with placebo | Risk with natalizumab | |||||
| Induction of clinical remission (CRITICAL) | 323/431 (74.9%) | 633/983 (64.4%) | RR 0.88 (0.82 to 0.96) | 24 fewer per 1,000 (from 36 fewer to 8 fewer) | 1414 (2 RCTs) | ⨁⨁⨁◯1 MODERATE |
| Maintenance of clinical remission (CRITICAL) | 133/170 (78.2%) | 76/168 (45.2%) | RR 0.58 (0.48 to 0.70) | 101 fewer per 1,000 (from 125 fewer to 72 fewer) | 338 (1 RCT) | ⨁⨁⨁◯2 MODERATE |
| Risk of progressive multifocal leukoencephalopathy (CRITICAL) | Positive for JC virus antibody: 0% | ~1% | RR >20 | 99,571 (Registry) | ||
| Negative for JC virus antibody: 0% | ~0.01% | 11.1 per 1,000 patients (95% CI, 8.3 to 14.5) | ⨁⨁◯◯3 LOW | |||
1
Rated down for imprecision since 95% CI of effect estimate was smaller than the minimal clinically important difference of at least 10% over placebo
2
Rated down for imprecision since optimal information size not met (<200 events)
3
Rated down for risk of bias (derived from observational studies)