Crohn’s disease: Cochrane reviews natalizumab for induction of remission

  • Nelson SM & al.
  • Cochrane Database Syst Rev
  • 1 Aug 2018

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • 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.

Study design

  • Meta-analysis of 5 randomised controlled trials involving 1771 participants with Crohn’s disease compared natalizumab with placebo.
  • Funding: None disclosed.

Key results

  • 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.

Limitations

  • All included studies were underpowered to detect rare but serious adverse events.

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