Related Experiment Video
Updated: Jun 11, 2026

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
Clinical evaluation of natalizumab for formulary consideration
Ashley Bivins1, Karolyn Hou, Nana Ayesu
1University of Maryland School of Pharmacy, Center on Drugs and Public Policy, Baltimore, MD 21201, USA.
Importance Of The Field:
Natalizumab is a monotherapy for relapsing forms of multiple sclerosis (MS) and maintaining remission in Crohn's disease (CD). Evaluation of natalizumab's clinical relevance must be performed before considering its place in treatment of these diseases.
Areas Covered In This Review:
MEDLINE and PubMed searches were performed using the keywords multiple sclerosis, Crohn's disease, natalizumab and clinical trials. The manufacturer's product information was consulted to extract additional data. Pivotal clinical trials included: Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM), Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis (SENTINEL), Efficacy of Natalizumab as Active Crohn's Therapy (ENACT)-1 and 2 and Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE).
What The Reader Will Gain:
AFFIRM and SENTINEL showed improvements in progression of MS. ENACT-1 failed to show a significant effect, but the follow-up trials ENACT-2 and ENCORE were able to demonstrate a response to natalizumab.
Take Home Message:
Two trials on efficacy of Tysabri for treatment of MS demonstrated positive results. Efficacy for CD was mixed. More research demonstrating head-to-head evidence against other agents is necessary to determine if Tysabri's benefits are significant.
Related Concept Videos
Therapeutic Drug Monitoring: Overview and Classification
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Drug Products: Biologics, Biosimilars and Interchangeables
Clinically Relevant Drug Product Specifications: Methods of Establishment
Bioequivalence studies: Biowaivers
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
