Cochrane · systematic review · CD006097
Natalizumab for induction of remission in Crohn's disease
Nelson, SML, Nguyen, TM, McDonald, JWD, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library
GutAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
33
current version
GRADE rated
32
No studies
1
Included studies
NR
No studies 1 · 3%Ungraded 0 · 0%Very low 0 · 0%Low 11 · 33.3%Moderate 14 · 42.4%High 7 · 21.2%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
One infusion of natalizumab (300 mg or 3 mg/kg) compared to placebo for induction of remission in Crohn's disease
Population: Participants with active Crohn's disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to induce remission at 2 weeks One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.94 [0.89, 0.98] | 3 studies · 1132 participants | Moderate Downgraded: inconsistency |
Failure to induce remission at 4 weeks One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.91 [0.86, 0.96] | 3 studies · 1611 participants | High |
Failure to induce clinical response at 2 weeks One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.82 [0.66, 1.01] | 2 studies · 1102 participants | Moderate |
Failure to induce clinical response at 4 weeks One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.78 [0.66, 0.92] | 3 studies · 1611 participants | Moderate |
Adverse events up to week 12 One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.91 [0.75, 1.09] | 1 study · 131 participants | Moderate Downgraded: imprecision, inconsistency |
Withdrawal due to adverse events up to week 12 One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.46 [0.04, 4.98] | 1 study · 131 participants | Low Downgraded: imprecision, inconsistency |
Serious adverse events up to week 12 One infusion of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.93 [0.34, 2.49] | 1 study · 131 participants | Low Downgraded: imprecision, inconsistency |
Two infusions of natalizumab (300 mg or 3 mg/kg) compared to placebo for induction of remission in Crohn's disease
Population: Participants with active Crohn's disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to induce remission at 6 weeks Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.85 [0.78, 0.93] | 2 studies · 1034 participants | High |
Failure to induce remission at 8 weeks Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.85 [0.76, 0.95] | 3 studies · 1543 participants | Moderate Downgraded: inconsistency |
Failure to induce clinical response at 6 weeks Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.66 [0.35, 1.25] | 2 studies · 1034 participants | Low |
Faliure to induce clinical response at 8 weeks Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.73 [0.58, 0.91] | 3 studies · 1543 participants | Low Downgraded: imprecision, inconsistency |
Adverse events up to week 12 Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 1.07 [0.92, 1.24] | 1 study · 129 participants | Moderate Downgraded: imprecision, inconsistency |
Withdrawal due to adverse events up to week 12 Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.95 [0.14, 6.57] | 1 study · 129 participants | Low Downgraded: imprecision, inconsistency |
Serious adverse events up to week 12 Two infusions of natalizumab (300 mg or 3 mg/kg) vs placebo | RR 0.82 [0.29, 2.3] | 1 study · 129 participants | Low Downgraded: imprecision, inconsistency |
Two infusions of natalizumab (6 mg/kg) compared to placebo for induction of remission in Crohn's disease
Population: Participants with active Crohn's disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to induce remission at 6 weeks Two infusions of natalizumab (6 mg/kg) vs placebo | RR 0.94 [0.74, 1.19] | 1 study · 114 participants | Moderate Downgraded: imprecision |
Failure to induce remission at 8 weeks Two infusions of natalizumab (6 mg/kg) vs placebo | RR 0.68 [0.52, 0.88] | 1 study · 114 participants | Moderate Downgraded: imprecision |
Failure to induce clinical response at 6 weeks Two infusions of natalizumab (6 mg/kg) vs placebo | RR 0.7 [0.48, 1.01] | 1 study · 114 participants | Moderate Downgraded: imprecision |
Failure to induce clinical response at 8 weeks Two infusions of natalizumab (6 mg/kg) vs placebo | RR 0.69 [0.49, 0.99] | 1 study · 114 participants | Moderate Downgraded: imprecision |
Adverse events up to week 12 Two infusions of natalizumab (6 mg/kg) vs placebo | RR 0.97 [0.8, 1.17] | 1 study · 114 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse events up to week 12 Two infusions of natalizumab (6 mg/kg) vs placebo | RR 1.85 [0.32, 10.67] | 1 study · 114 participants | Low Downgraded: imprecision |
Serious adverse events up to week 12 Two infusions of natalizumab (6 mg/kg) vs placebo | RR 1.06 [0.38, 2.95] | 1 study · 114 participants | Low Downgraded: imprecision |
Three infusions of natalizumab (300 mg) compared to placebo for induction of remission in Crohn's disease
Population: Participants with active Crohn's disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to induce remission at 10 weeks Three infusions of natalizumab (300 mg) vs placebo | RR 0.91 [0.81, 1.01] | 1 study · 905 participants | High |
Failure to induce remission at 12 weeks Three infusions of natalizumab (300 mg) vs placebo | RR 0.85 [0.78, 0.92] | 2 studies · 1414 participants | High |
Failure to induce clinical response at 10 weeks Three infusions of natalizumab (300 mg) vs placebo | RR 0.85 [0.72, 1] | 1 study · 905 participants | High |
Failure to induce clinical response at 12 weeks Three infusions of natalizumab (300 mg) vs placebo | RR 0.76 [0.67, 0.86] | 2 studies · 1414 participants | High |
Adverse events up to week 12 Three infusions of natalizumab (300 mg) vs placebo | RR 1.03 [0.98, 1.08] | 2 studies · 1415 participants | High |
Withdrawal due to adverse event up to week 12 Three infusions of natalizumab (300 mg) vs placebo | RR 0.86 [0.59, 1.26] | 2 studies · 1415 participants | Moderate Downgraded: imprecision |
Serious adverse events up to week 12 Three infusions of natalizumab (300 mg) vs placebo | RR 0.76 [0.37, 1.56] | 2 studies · 1414 participants | Low Downgraded: imprecision, inconsistency |
Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) compared to placebo and two infusions of infliximab for induction of remission in Crohn's disease
Population: Participants with active Crohn's disease despite current treatment with infliximab
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to induce clinical remission at week 10 Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) vs placebo and two infusions of infliximab | RR 0.9 [0.65, 1.24] | 1 study · 79 participants | Moderate Downgraded: imprecision |
Failure to induce clinical response at 10 weeks Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) vs placebo and two infusions of infliximab | no estimate extracted | NR | No studies |
Adverse events up to week 10 Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) vs placebo and two infusions of infliximab | RR 0.93 [0.85, 1.03] | 1 study · 79 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse events up to week 10 Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) vs placebo and two infusions of infliximab | RR 0.18 [0.01, 4.18] | 1 study · 79 participants | Low Downgraded: imprecision |
Serious adverse events up to week 10 Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) vs placebo and two infusions of infliximab | RR 0.52 [0.03, 7.98] | 1 study · 79 participants | Low Downgraded: imprecision |