Related Experiment Video
Updated: May 22, 2026

Analyzing Tumor and Tissue Distribution of Target Antigen Specific Therapeutic Antibody
Published on: May 16, 2020
Belimumab is approved by the FDA: what more do we need to know to optimize decision making?
Diane Lewis Horowitz1, Richard Furie
1Division of Rheumatology and Allergy-Clinical Immunology, Hofstra North Shore-LIJ School of Medicine, Manhasset, NY, USA. dhorowitz@nshs.edu
Abstract:
The March 2011 approval of belimumab (Benlysta) by the US Food and Drug Administration has left rheumatologists in a bit of a quandary regarding its use. It is officially intended for adult patients with autoantibody-positive systemic lupus erythematosus whose disease remains active despite receipt of standard-of-care therapy. The approved indication is broad and leaves interpretation to individual rheumatologists. Analyses of the phase 2 and 3 clinical trials of belimumab help answer some of the commonly asked questions, such as the following: 1) Who is the appropriate patient for belimumab? 2) How does one measure response? 3) When should results be expected in a patient newly treated with belimumab? 4) When should belimumab be discontinued?
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Inflammatory Bowel Disease IV: Pharmacological Management
Pharmacologic...
FDA Approved Drugs: Changes to Approved Drugs
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
