Lead Investigator: Chiara Tani, University of Pisa
Title of Proposal Research: Evaluation of gender differences in the efficacy and safety of belimumab in the treatment of active systemic lupus erythematosus
Vivli Data Request: 8315
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. There is no cure for lupus, but medical interventions and lifestyle changes can help control it.
SLE is chronic and typically affects young subjects with a clear predomimance in females; the estimated female-to-male ratio is of about 9:1. The overall prevalence ranges from 15 to 60/100000 based on the geographical areas; SLE in men is certainly a rare condition.
Because of the epidemiological characteristics of the disease, much of the information that we have on this condition is based on analyses conducted on predominantly female patient groups. However, we know that the disease can take a different course in males and females with different modes of clinical presentation and different long-term outcomes. We also know that there are significant differences between men and women in their response to treatment. Belimumab is an approved therapy for the treatment of active SLE; numerous studies have shown its efficacy in controlling disease manifestations and preventing organ damage.
The study we propose aims to analyze and compare the response to belimumab treatment in male and female patients . The results of this study will provide a better understanding of whether there are gender disparities in response to therapy and, therefore, investigate strategies for personalizing treatment. Indeed, precision medicine is the new frontier of medicine especially for the treatment of chronic diseases; it is based on a new approach to the treatment and prevention of disease that takes into account individual variability in genetic characteristics, environment, and lifestyles. We thus move from treatments aimed at the “average patient” to therapies tailored to the patient with certain characteristics, with the intention of achieving better results through, for example, targeted prevention strategies and the use of ad hoc drugs. This could be particularly important in a complex disease such as SLE.
The study will be conducted by combining data from the the results from 3 clinical trials that have employed the drug belimumab to treat patients with active SLE. This methodology will ensure that we have a large sample of patients to analyze and greater statistical power of the results.
Requested Studies:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT00424476
Sponsor ID: HGS1006-C1057
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT00410384
Sponsor ID: HGS1006-C1056
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT01484496
Sponsor ID: 112341