- Meta-analysis of high-quality studies suggests that natalizumab is effective for induction of clinical remission and response in patients with active Crohn’s disease.
- None of the studies reported progressive multifocal leukoencephalopathy (PML); studies were however underpowered to detect PML.
Why this matters
- Due to availability of alternate agents that are not associated with PML, risk-benefit ratio should be carefully assessed before using natalizumab in selected patients.
- Meta-analysis of 5 randomised controlled trials involving 1771 participants with Crohn’s disease compared natalizumab with placebo.
- Funding: None disclosed.
- 1 infusion of natalizumab vs placebo:
- At week 4, significantly lower number of participants receiving natalizumab failed to enter remission (risk ratio [RR], 0.91; 95% CI, 0.86-0.96) or respond to treatment (RR, 0.78; 95% CI, 0.66-0.92).
- Patients in the natalizumab group had significantly greater change in Crohn’s disease Activity Index (CDAI) from baseline (mean difference [MD], −32.90; 95% CI, −47.85 to −17.95).
- 2 infusions of natalizumab vs placebo
- At week 8, the risk for failing to enter remission (RR, 0.85; 95% CI, 0.76-0.95) or response to treatment (RR, 0.73; 95% CI, 0.58-0.91) was significantly lower with natalizumab.
- Patients in the natalizumab group had a significantly greater change in CDAI from baseline (MD, −38.60; 95% CI, −55.26 to −21.94).
- 3 infusions of natalizumab vs placebo
- At week 12, natalizumab was associated with significantly lower risk for failure to enter remission (RR, 0.85; 95% CI, 0.78-0.98) or respond to treatment (RR, 0.76; 95% CI, 0.67-0.86).
- Mean change in CDAI from baseline was higher in the natalizumab group (MD, −49.60; 95% CI, −67.35 to −31.85).
- No statistically significant difference was observed in adverse event rates.
- There were no reported cases of PML.
- All included studies were underpowered to detect rare but serious adverse events.