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Lecanemab-irmb

(Leqembi®)

Leqembi®

Drug updated on 10/21/2024

Dosage FormInjection (intravenous; 500 mg/5 mL [100 mg/mL], 200 mg/2 mL [100 mg/mL])
Drug ClassAmyloid beta-directed antibodies
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of Alzheimers disease.

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Summary
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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-2]
  • Lecanemab significantly reduced brain amyloid-beta plaques (difference 0.45; 95% CI, 0.67 to 0.23; p < .001) and moderately slowed clinical progression in patients with amyloid pathology (SMD -0.194; 95% CI, -0.279 to -0.108), as well as demonstrated positive effects on cognitive outcomes such as ADCOMS, CDR-SB (P = 0.01), and ADAS-cog14 scores.
  • Lecanemab showed beneficial effects in reducing the accumulation of beta-amyloid and cognitive decline, with improvements in cognitive and functional scales, although these changes were below the minimal clinically important difference (MCID).
  • The effectiveness of lecanemab was primarily observed in early-stage Alzheimer’s disease (AD) patients, particularly those with mild cognitive impairment or mild dementia and amyloid pathology. Subgroup analysis indicated potential considerations based on APOE4 genetic status for patient selection.
  • Lecanemab was associated with a higher frequency of amyloid-related imaging abnormalities (ARIA), particularly ARIA-H (17.3% vs. 9.0%) and ARIA-E (12.6% vs. 1.7%) compared to placebo. Common adverse events included headache, infusion-related reactions, and ARIA-E.
  • Lecanemab showed no significant difference in the occurrence of serious adverse events compared to placebo in early Alzheimer's disease patients. However, the risks of ARIA-edema (RR = 10.29; NNH = 9) and ARIA-hemorrhage (RR = 1.74; NNH = 13) were notably increased.
  • Specific safety concerns related to ARIA were more pronounced in patients with amyloid pathology, and APOE4 genetic status may influence the safety profile and treatment response in these patients.
  • Lecanemab studies primarily focused on early-stage Alzheimer’s disease (AD) patients, particularly those with mild cognitive impairment or mild dementia, and with confirmed amyloid pathology. Subgroup analyses highlighted the relevance of the APOE4 genetic status, which may influence both treatment efficacy and safety outcomes.