Year: 2010
Type: editorial
Abstract: The latest report that belimumab, a human monoclonal antibody targeting BAFF (B-cell activating factor, also known as TNF ligand superfamily member 13B or BLyS), was not better than placebo in controlling signs and symptoms of systemic lupus erythematosus (SLE) after 76 weeks re-emphasizes the difficulty of developing new drugs for this disease. Previous positive results after 1 year of therapy with belimumab in the BLISS-52 and BLISS-76 trials had been the only positive outcome in recent SLE trials, and had served to stimulate a belief that development of new therapies was not only possible, but also likely. However, the new results reported in a press release not only question the impact of belimumab, but also raise important issues about the underlying assumptions of SLE clinical trials. Is our understanding of SLE immunopathogenesis correct? Do we actually understand the basis of all clinical manifestations of SLE sufficiently to expect positive results from highly targeted therapies? Are the clinical trials designed appropriately? Is patient heterogeneity too great to see a therapeutic impact? Are we able to identify patients with lupus with a sufficiently high probability of responding to warrant further clinical trials? All of these issues, and many others, must be reconsidered before more money, effort and the good will of more patients who participate in trials are squandered in fruitless pursuits. To quote the Major League Baseball player Yogi Berra, “The future ain't what it used to be.”
Source: Nature Reviews Rheumatology
Authors: Peter E. Lipsky, Thomas Dörner
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2030584517