Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis

Fuchs E
Record ID 32018000337
Authors' objectives: The aim of this systematic review was to investigate whether natalizumab is more effective and safer than alternative pharmacological therapies or placebo over a minimum follow-up period of 36 months with respect to annualised relapse rate, disability progression, quality of life (QoL) and number of serious adverse events (SAEs).
Authors' results and conclusions: For the assessment of clinical effectiveness, three studies met the inclusion criteria. No significant differences regarding the annualised relapse rate and disability progression were found, when natalizumab was compared to fingolimod. A single trial investigated the patient-reported outcome quality of life. Yet, no significant difference was observed between the intervention group and a placebo control. For the assessment of safety, seven studies met the inclusion criteria. The proportion of patients suffering from SAEs ranged from 2.4% to 16.0%. Among them, infections and infestations (up to 4.0%), neoplasms (up to 2.0%) and hypersensitivity reactions (0.5% to 2.0%) were reported most frequently. In total, 35 cases of PML occurred. Conclusion: Concerning clinical effectiveness and safety, the quality of evidence was low to very low.
Authors' recomendations: Future research should provide more head-to-head RCTs comparing natalizumab with other disease modulating drugs along with a comprehensive documentation of adverse events.
Authors' methods: A systematic literature search was conducted in four databases. The risk of bias (RoB) was assessed using the Cochrane RoB tool for randomised controlled studies and the ROBINS-I tool for non-randomised controlled trials. The quality of evidence was assessed using the GRADE-method (Grading of Recommendations, Assessment, Development and Evaluation).
Project Status: Completed
Year Published: 2019
URL for additional information:
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Multiple Sclerosis, Relapsing-Remitting
  • Natalizumab
  • Therapeutics
  • Pharmacology
  • Natalizumab
  • Tysabri™
  • Multiple Sclerosis
  • Relapsing-Remitting Multiple Sclerosis
  • efficacy
  • adverse events
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
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This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.