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Belimumab May Be First Biologic Okayed for SLE


 

Anti–interleukin-6. Tocilizumab (RoActemra) achieved improvements in SLEDAI and arthritis in a recent National Institutes of Health phase I study in 16 SLE patients (Arthritis Rheum. 2010;62:542-52). Neutropenia was a frequent limiting side effect. Additional interleukin-6 and interleukin-6 receptor antagonists are in early clinical trials.

Rituximab. Early, uncontrolled studies were “exciting and encouraging,” recalled Dr. van Vollenhoven, who led several of them. Then came the failed phase III, randomized, double-blind, controlled EXPLORER and LUNAR trials, which contributed prominently to the glum global prospects for biologic therapy of a year ago. EXPLORER established that rituximab (Rituxan) is unlikely to be of benefit in nonrenal lupus. Many rheumatologists have concluded that LUNAR showed the same for lupus nephritis, but Dr. van Vollenhoven, who was on the trial's steering committee, remains unconvinced. In as-yet-unpublished data, he has shown that rituximab works quite slowly in lupus nephritis, with about one-half of treated patients showing a partial response after 1 year, and complete responses being seen only after about 2 years. LUNAR, he noted, was a 1-year trial, so it didn't capture the late responses. “It could be that rituximab doesn't work in lupus nephritis. But I'll reserve my judgment because I've seen such good responses that it still seems to me to be a pretty good option,” he said.

Disclosures: Dr. van Vollenhoven serves as a consultant to GlaxoSmithKline and Human Genome Sciences, which are developing belimumab, and he has received research grants from most of the other companies which make biologics for rheumatologic diseases. Dr. Wallace is a consultant to UCB, which is developing epratuzumab and funded the EMBLEM trial.

Early data from the EMBLEM trial show that epratuzumab halved, rather than eliminated, B cell numbers.

Source DR. WALLACE

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